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    Prevention of wound complications following salvage laryngectomy using free vascularized tissue

    HEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 5 2007
    FRCS(C), Kevin Fung MD
    Abstract Background. Total laryngectomy following radiation therapy or concurrent chemoradiation therapy is associated with unacceptably high complication rates because of wound healing difficulties. With an ever increasing reliance on organ preservation protocols as primary treatment for advanced laryngeal cancer, the surgeon must develop techniques to minimize postoperative complications in salvage laryngectomy surgery. We have developed an approach using free tissue transfer in an effort to improve tissue vascularity, reinforce the pharyngeal suture line, and minimize complications in this difficult patient population. The purpose of this study was to outline our technique and determine the effectiveness of this new approach. Methods. We conducted a retrospective review of a prospective cohort and compared it with a historical group (surgical patients of Radiation Therapy Oncology Group (RTOG)-91-11 trial). Eligibility criteria for this study included patients undergoing salvage total laryngectomy following failed attempts at organ preservation with either high-dose radiotherapy or concurrent chemo/radiation therapy regimen. Patients were excluded if the surgical defect required a skin paddle for pharyngeal closure. The prospective cohort consisted of 14 consecutive patients (10 males, 4 females; mean age, 58 years) who underwent free tissue reinforcement of the pharyngeal suture line following total laryngectomy. The historical comparison group consisted of 27 patients in the concomitant chemoradiotherapy arm of the RTOG-91-11 trial who met the same eligibility criteria (26 males, 1 female; mean age, 57 years) but did not undergo free tissue transfer or other form of suture line reinforcement. Minimum follow-up in both groups was 12 months. Results. The overall pharyngocutaneous fistula rate was similar between groups,4/14 (29%) in the flap group, compared with 8/27 (30%) in the RTOG-91-11 group. There were no major wound complications in the flap group, compared with 4 (4/27, 14.8%) in the RTOG-91-11 group. There were no major fistulas in the flap group, compared with 3/27 (11.1%) in the RTOG-91-11 group. The rate of pharyngeal stricture requiring dilation was 6/14 (42%) in the flap group, compared with 7/27 (25.9%) in the RTOG-91-11 group. In our patients, the rate of tracheoesophageal speech was 14/14 (100%), and complete oral intake was achieved in 13/14 (93%) patients. Voice-Related Quality of Life Measure (V-RQOL) and Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) scores suggest that speech and swallowing functions are reasonable following free flap reinforcement. Conclusions. Free vascularized tissue reinforcement of primary pharyngeal closure in salvage laryngectomy following failed organ preservation is effective in preventing major wound complications but did not reduce the overall fistula rate. Fistulas that developed following this technique were relatively small, did not result in exposed major vessels, and were effectively treated with outpatient wound care rather than readmission to the hospital or return to operating room. Speech and swallowing results following this technique were comparable to those following total laryngectomy alone. © 2007 Wiley Periodicals, Inc. Head Neck 2007 [source]


    Role of Intralesional Bleomycin in the Treatment of Complicated Hemangiomas: Prospective Clinical Study

    DERMATOLOGIC SURGERY, Issue 5 2005
    Shapour Omidvari MD
    background. Hemangioma is the most common tumor of infancy. Although it has a basically benign nature and usually spontaneously regresses, a small percentage (5%) have complications that need treatment. Many different therapeutic modalities can be used in this tumor. objective. To investigate the effect of a new method of treatment (intralesional bleomycin injection) in complicated hemangiomas. materials and methods. In the Department of Radiation Oncology at Nemazee Hospital in Shiraz, Iran, from April 1992 to October 1998, 32 patients with complicated hemangioma were treated with four to six courses of direct injection of bleomycin into the lesion. results After a minimum follow-up of 6 years, there was 70 to 100% regression in 18 patients, 50 to 70% in 7 cases, and less than 50% reduction in 7 patients. conclusion. Intralesional injection of bleomycin is an easy, safe, and effective therapeutic modality in complicated cutaneous hemangiomas. [source]


    Hemispheric Surgery in Children with Refractory Epilepsy: Seizure Outcome, Complications, and Adaptive Function

    EPILEPSIA, Issue 1 2007
    Sheikh Nigel Basheer
    Summary:,Purpose: To describe seizure control, complications, adaptive function and language skills following hemispheric surgery for epilepsy. Methods: Retrospective chart review of patients who underwent hemispheric surgery from July 1993 to June 2004 with a minimum follow-up of 12 months. Results: The study population comprised 24 children, median age at seizure onset six months and median age at surgery 41 months. Etiology included malformations of cortical development (7), infarction (7), Sturge-Weber Syndrome (6), and Rasmussen's encephalitis (4). The most frequent complication was intraoperative bleeding (17 transfused). Age <2 yr, weight <11 kg, and hemidecortication were risk factors for transfusion. Postoperative complications included aseptic meningitis (6), and hydrocephalus (3). At median follow-up of 7 yr, 79% of patients are seizure free. Children with malformations of cortical development and Rasmussen's encephalitis were more likely to have ongoing seizures. Overall adaptive function scores were low, but relative strengths in verbal abilities were observed. Shorter duration of epilepsy prior to surgery was related significantly to better adaptive functioning. Conclusions: Hemispheric surgery is an effective therapy for refractory epilepsy in children. The most common complication was bleeding. Duration of epilepsy prior to surgery is an important factor in determining adaptive outcome. [source]


    Cortical Resection with Electrocorticography for Intractable Porencephaly-related Partial Epilepsy

    EPILEPSIA, Issue 1 2005
    Koji Iida
    Summary:,Purpose: We evaluated the results of cortical resection of epileptogenic tissue for treatment of intractable porencephaly-related epilepsy. Methods: We examined clinical features, electrophysiological data, surgical findings, and seizure outcomes after cortical resection in eight patients with intractable epilepsy related to porencephalic cysts. Results: All eight patients had hemiparesis. Five retained motor function in the hemiparetic extremities; six retained visual fields. All had partial seizures, six with secondary generalization. Seven patients had simple and three had complex partial seizures (CPSs); two also had drop attacks. Four patients had multiple seizure types. Long-term scalp video-EEG (LVEEG) localized interictal epileptic abnormalities that anatomically corresponded to the cyst location in three patients. LVEEG recorded ictal-onset zones in five; these anatomically corresponded to the cyst location in three of the five. EEG recorded generalized seizures in two patients, hemispheric in one, and multifocal in two. Intraoperative electrocorticography (ECoG) revealed interictal epileptic areas extending beyond the margins of the cyst in seven patients. We resected ECoG-localized interictal epileptic areas completely in five patients and partially in two. Cortical resection was based on seizure semiology and LVEEG in one patient whose ECoG showed no epileptiform discharges. After a minimum follow-up of 1 year, six patients had excellent seizure outcome (Engel class I), and two had a >90% seizure reduction (Engel class III) without complications. Conclusions: Cortical resection guided by ECoG allows preservation of motor function and visual field and provides an effective surgical procedure for treatment of intractable epilepsy secondary to porencephaly. [source]


    Clinical impact of, and prognostic stratification by, F-18 FDG PET/CT in head and neck mucosal squamous cell carcinoma

    HEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 11 2007
    Caroline A. Connell FRANZCR
    Abstract Background The aim of this study was to determine prospectively the incremental value of positron emission tomography/computed tomography (PET/CT) over conventional assessment (clinical examination and CT/MRI imaging). Methods All patients undergoing 18F-fluorodeoxyglucose (FDG)-PET/CT for primary head and neck mucosal squamous cell carcinoma between January 2002 and December 2003 (inclusive) were included in this study provided they had undergone contemporaneous conventional assessment of the head and neck region and had 12 months minimum follow-up. Results Seventy-six patients underwent 100 PET/CT scans. The majority of patients (74%) were treated with definitive (chemo)radiotherapy. Median follow-up time was 28 months. PET/CT led to a TNM classification alteration in 34% (12/35), a change in radiotherapy planning technique and/or dose in 29% (10/35), and altered treatment response assessment in 43% (13/30). A complete metabolic response was predictive of overall survival (p = .037). Conclusion Our results support incorporation of PET/CT into the management paradigm of head and neck mucosal squamous cell carcinoma. © 2007 Wiley Periodicals, Inc. Head Neck 2007 [source]


    Effectiveness of routine follow-up of patients treated for T1,2N0 oral squamous cell carcinomas of the floor of mouth and tongue

    HEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 1 2006
    Matthias Adrianus Wilhelmus Merkx MD
    Abstract Background. The duration of follow-up after treatment for head and neck cancer, the depth of the routine visits, and the diagnostic tools used are determined on the basis of common acceptance rather than evidence-based practice. Patients with early-stage tumors are more likely to benefit from follow-up programs, because they have the best chance for a second curative treatment after recurrence. The purpose of this study was to determine the benefit of our 10-year follow-up program in patients with stage I and II squamous cell carcinoma (SCC) of the floor of mouth and tongue. Methods. In a longitudinal cohort study involving 102 patients who were treated with curative intent for a pT1,2N0M0 SCC of the floor of mouth and tongue from 1989,1998 with a minimum follow-up of 5 years, we evaluated the effect of routine follow-up. Results. During the follow-up (mean, 61 months; SD, 4 months), 10 patients had a recurrence, and 20 patients had a second primary tumor. No regional lymph node recurrences in the neck were detected. Location, T classification of the primary tumor, choice of therapy, or measure of tumor-free margins in the resection did not significantly affect the occurrence of a secondary event (p , .1). The secondary event was discovered during a patient-initiated visit for complaints in 14 patients and was found during routine follow-up visits in 16 patients. Only seven second primary tumors were detected after 60 months, four on routine follow-up and three on a self-initiated visit. The mean disease-free survival time after treatment of the secondary event was 72 months (SD, 17 months) in the "own initiative" group and 65 months (SD, 13 months) in the routine follow-up group; this difference was not statistically significant (p = .3). Conclusions. The effectiveness of a 10-year routine follow-up, even in patients with early-stage oral SCC, is very limited. These visits on routine basis can be stopped after 5 years. © 2005 Wiley Periodicals, Inc. Head Neck27: XXX,XXX, 2005 [source]


    Outcome of treatment for advanced cervical metastatic squamous cell carcinoma

    HEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 2 2005
    Jonathan Clark FRACS
    Abstract Background. Patients with advanced cervical metastases from mucosal squamous cell carcinoma have a poor prognosis because of their high risk of regional and distal failure. This study aims to evaluate the outcomes of patients with clinical N2 or N3 disease managed with surgery and postoperative radiotherapy. Methods. From a comprehensive computerized database, 181 entered patients who had neck dissection for N2 or N3 disease between 1988 and 1999 were evaluated. The mean age was 62 years, and minimum follow-up was 3 years. Results. A total of 233 neck dissections were performed in 181 patients, including 163 comprehensive and 70 selective dissections. Postoperative radiotherapy was given in 82% of cases. The local control rate was 75% at 5 years, and control of disease in the treated neck was achieved in 86%. Macroscopic extracapsular spread (ECS) significantly increased regional recurrence (p = .001). Adjuvant radiotherapy significantly improved neck control (p = .004) but did not alter survival. Patients with ECS (both microscopic and macroscopic) who received radiotherapy had a significantly better survival than did patients with ECS who did not receive radiotherapy. Disease-specific survival for the entire group was 39% at 5 years. By use of multivariate analysis, macroscopic ECS and N2c neck disease were independent adverse prognostic factors for survival (p = .001). Conclusions. Despite a high rate of control in the treated neck, the poor survival (39%) in this patient group indicates that adjuvant therapeutic strategies need to be considered. © 2004 Wiley Periodicals, Inc. Head Neck27: 87,94, 2005 [source]


    Metastatic squamous cell carcinoma of the neck from an unknown primary: Management options and patterns of relapse,

    HEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 3 2002
    Shahrokh Iganej MD
    Abstract Purpose Management of squamous cell carcinoma of undetermined primary tumors in the head and neck region is controversial. Here we report the Southern California Kaiser Permanente experience with these patients. Methods and Materials From January 1969 through December 1994, 106 patients were eligible for this retrospective analysis. Distribution of nodal staging was as follows: 14 N1, 27 N2A, 39 N2B, 2 N2C, and 24 N3. Initial treatment included excisional biopsy alone in 12, radical neck dissection alone in 29, radiotherapy alone in 24, excisional biopsy followed by radiotherapy in 15, and radical neck dissection plus postoperative radiation in 26 patients. Results Except for two patients, all patients have had a minimum follow-up of 5 years. Overall, 57 patients (54%) have had recurrences. Only two patients (3%) who had received radiotherapy as part of their initial treatment had an appearance of a potential primary site inside the irradiated field vs 13 patients (32%) who had not received radiotherapy (p = .006). Combined modality therapy resulted in fewer neck relapses, particularly in patients with advanced neck disease. Including salvage, surgery alone as the initial treatment resulted in 81% ultimate tumor control above the clavicle for patients with N1 and N2a disease without extracapsular extension. The 5-year survival for the entire population was 53%. Radiotherapy alone resulted in poor survival in patients with advanced/unresectable neck disease. No significant difference in survival based on the initial treatment was found. The statistically significant adverse factors in determining survival included advanced nodal stage and the presence of extracapsular extension. Conclusions Radiotherapy is very effective in reducing the rate of appearance of a potential primary site. However, in the absence of advanced neck disease (N1 and N2A without extracapsular extension), radiotherapy can be reserved for salvage. Radiotherapy alone results in poor outcomes in patients with advanced/unresectable neck disease, and incorporation of concurrent chemotherapy and cytoprotective agents should be investigated. © 2002 Wiley Periodicals, Inc. Head Neck 24: 236,246, 2002; DOI 10.1002/hed.10017 [source]


    Response of refractory colitis to intravenous or oral tacrolimus (FK506)

    INFLAMMATORY BOWEL DISEASES, Issue 5 2002
    Dr. Klaus Fellermann
    Abstract Intravenous cyclosporine has proven to be an alternative to emergency colectomy in steroid-refractory ulcerative colitis, whereas the experience with FK506 is limited. In this report we compare intravenous to oral FK506 treatment in 38 patients with refractory ulcerative (n = 33) or indeterminate (n = 5) colitis. FK506 was started intravenously in the first group (n = 18) at a dose of 0.01 to 0.02 mg/kg up to 14 days, followed by 0.1 to 0.2 mg/kg orally, or was started orally at this dose in a second group (n = 20). Additional azathioprine/6-mercaptopurine was given and steroids were tapered in responding patients, followed by a dose reduction of FK506. Clinical disease activity and laboratory parameters were assessed to evaluate efficacy and safety. Primary objectives were the induction of remission (Truelove index of mild) and colectomy-free survival. Treatment lasted for a mean of 7.6 months, and the mean observation period was 16.2 months. Eighteen of 38 patients improved within 14 days, and a complete remission was achieved in 13 patients after 1 month. A colectomy within 1 month was performed in 3 of 38 patients. The overall colectomy rate was 34%. One-half of the patients with a minimum follow-up of 2 years required a colectomy. Intravenous and per oral administration were equally safe and effective. The most frequent adverse events included tremor, hyperglycemia, hypertension, and infection, but none were severe. Renal impairment was rare and subsided upon drug withdrawal. In conclusion, FK506 is effective in the treatment of refractory colitis with per oral dosing being equivalent to intravenous administration. [source]


    Longitudinal quantitative evaluation of lesion size change in femoral head osteonecrosis using three-dimensional magnetic resonance imaging and image registration

    JOURNAL OF ORTHOPAEDIC RESEARCH, Issue 6 2006
    Masaki Takao
    Abstract It remains controversial whether some lesions of femoral head osteonecrosis regress during the natural course of the disease. With image registration, accurately matched image sets of the same subject can be acquired at different times. We applied image registration to evaluate lesion size change and assessed accuracy and usefulness compared to volume measurements and a conventional method. We also investigated whether lesions regress with this technique and with volume measurements. Baseline and 1 year minimum follow-up scans were conducted on 25 patients (31 hips) without radiological evidence of collapse. A three-dimensional (3D) spoiled gradient recalled echo sequence was used in the coronal direction (slice thickness,=,2 mm; slice pitch,=,1 mm). Size change was evaluated on all contiguous pairs of matched images after image registration. As a conventional method, coronal images (slice thickness,=,5 mm) were reconstructed, and size change was evaluated on the five representative coronal slices. Evaluation with the conventional method identified eight lesions with apparent reduction; assessments using image registration and volume measurements identified three lesions, all within a year of initial steroid treatment and remaining at ARCO stage I at follow up. Evaluation of lesion size change using image registration was comparable to volume measurements. Inaccurate estimation of lesion size change due to mismatching of slice planes can be excluded. We demonstrated that some early lesions detected less than a year after initial steroid treatment can show size reduction with image registration as well as with volume measurements. © 2006 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 24:1231,1239, 2006 [source]


    Long-Term Survival in Patients Treated with Cardiac Resynchronization Therapy: A 3-Year Follow-Up Study from the InSync/InSync ICD Italian Registry

    PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 2006
    MAURIZIO GASPARINI
    Background: Studies reporting the long-term survival of patients treated with cardiac resynchronization therapy (CRT) outside the realm of randomized controlled trials are still lacking. The aim of this study was to quantify the survival of patients treated with CRT in clinical practice and to investigate the long-term effects of CRT on clinical status and echocardiographic parameters. Methods: The study population consisted of 317 consecutive patients with implanted CRT devices from eight Italian University/Teaching Hospitals. The patients were enrolled in a national observational registry and had a minimum follow-up of 2 years. A visit was performed in surviving patients and mortality data were obtained by hospital file review or direct telephone contact. Results: During the study period, 83 (26%) patients died. The rate of all-cause mortality was significantly higher in ischemic than nonischemic patients (14% vs 8%, P = 0.002). Multivariate analysis showed that ischemic etiology (HR 1.72, CI 1.06,2.79; P = 0.028) and New York Heart Association (NYHA) class IV (HR 2.87, CI 1.24,6.64; P = 0.014) were the strongest predictors of all-cause mortality. The effects of CRT persisted at long-term follow-up (for at least 2 years) in terms of NYHA class improvement, increase of left ventricular ejection fraction, decrease of QRS duration (all P = 0.0001), and reduction of left ventricular end-diastolic and end-systolic diameters (P = 0.024 and P = 0.011, respectively). Conclusions: During long-term (3 years) follow-up after CRT, total mortality rate was 10%/year. The outcome of ischemic patients was worse mainly due to a higher rate of death from progressive heart failure. Ischemic etiology along with NYHA class IV was identified as predictors of death. Benefits of CRT in terms of clinical function and echocardiographic parameters persisted at the time of long-term follow-up. [source]


    Influence of Polyps on Outcomes After Endoscopic Sinus Surgery

    THE LARYNGOSCOPE, Issue 10 2007
    Neil Bhattacharyya MD
    Abstract Objective: To determine clinical and comparative outcomes for endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) with polyposis. Methods: Two cohorts of adult patients with refractory CRS with and without nasal polyps were prospectively studied before and after ESS (minimum follow-up, 12 months) with the Rhinosinusitis Symptom Inventory (RSI). For the non-polyp and polyp cohorts, RSI symptom domains and medical resource utilization were compared in the preoperative and postoperative states. Corresponding effect sizes were computed and compared between cohorts to determine the effect of polyps on prognosis after ESS. Results: A total of 165 non-polyp and 86 polyp patients were enrolled. Polyps were more common in female patients (2:1, P = .025); age (mean, 42.9 years) and follow-up (18.5 months) were similar between groups. Lund scores were significantly higher for polyp patients (13.7, SD 4.8) vs. non-polyp patients (8.1, SD 5.3, P < .001). At baseline, polyp patients reported lower symptom scores for facial, oropharyngeal, and systemic RSI symptom domains (all P < .012); nasal and total symptom domains were similar between groups. Both non-polyp and polyp groups obtained significant symptomatic benefit from ESS with effect sizes for RSI symptom domain improvements ranging from 0.89 to 1.38 and 0.43 to 1.19, respectively (all P < .001). There were no significant differences between groups in symptomatic improvement, excepting oropharyngeal symptoms (better improvement in non-polyp group, P = .024). Non-polyp patients decreased medical resource consumption more significantly than did polyp patients. Conclusions: Both non-polyp and polyp patients derive similar clinically significant symptomatic improvement after ESS. These similarities suggest that polyp patients do not necessarily have a poorer symptomatic outcome after ESS. [source]


    Surgery and Adjuvant Radiotherapy in Patients with Cutaneous Head and Neck Squamous Cell Carcinoma Metastatic to Lymph Nodes: Combined Treatment Should be Considered Best Practice,

    THE LARYNGOSCOPE, Issue 5 2005
    FRANZCR, Michael J. Veness MMed
    Abstract Objective: Patients with cutaneous squamous cell carcinoma (SCC) may develop metastatic SCC to nodes in the head and neck. Recent data support best outcome with the addition of adjuvant radiotherapy. This study aims to present further supportive evidence. Study Design: Retrospective chart review. Methods: Patients were identified with metastatic cutaneous SCC to nodes of the head and neck treated with surgery or surgery and adjuvant radiotherapy. Relapse and outcome were analyzed using Cox regression analysis. Disease-free survival and overall survival rates were calculated using Kaplan-Meier survival curves. Results: Between 1980 to 2000, 167 patients were treated with curative intent at Westmead Hospital, Sydney. Median age was 67 years (range, 34,95) in 143 men and 24 women with a minimum follow-up of 24 months. Patients underwent surgery (21/167; 13%), or surgery and adjuvant radiotherapy (146/167; 87%). The majority (98/167; 59%) of metastatic nodes were located in the parotid and/or cervical nodes. The remaining 69 (41%) had metastatic cervical nodes (levels I,V). Forty-seven patients (28%) had recurrences, with the majority (35/47; 74%) as locoregional failures. On multivariate analysis, spread to multiple nodes and single-modality treatment significantly predicted worse survival. Patients undergoing combined treatment had a lower rate of locoregional recurrence (20% vs. 43%) and a significantly better 5-year disease-free survival rate (73% vs. 54%; P = .004) compared to surgery alone. Conclusions: In patients with metastatic cutaneous head and neck SCC, surgery and adjuvant radiotherapy provide the best chance of achieving locoregional control and should be considered best practice. [source]


    Lipotransfer as an Adjunct in Head and Neck Reconstruction

    THE LARYNGOSCOPE, Issue 9 2003
    FRCS(C), Yadranko Ducic MD
    Abstract Objectives To present our technique of lipotransfer and to evaluate a single center's experience in the use of lipotransfer as an adjunct to head and neck reconstruction. Study Design A retrospective review of all patients undergoing lipotransfer over a 5-year period by the senior author was undertaken. A total of 23 patients with a minimum follow-up of 1 year were available for analysis. Methods Patient records were retrospectively reviewed to assess functional (in the case of palate augmentation) and esthetic outcomes. Results Twenty-three patients undergoing lipotransfer as part of their reconstructive effort included (1) eight patients undergoing temporal fossa augmentation following temporalis muscle flap reconstruction for extirpative skull base surgery, (2) six patients undergoing facial defect augmentation following traumatic atrophy, (3) three patients undergoing palatal augmentation for correction of velopharyngeal insufficiency, and (4) six patients undergoing soft tissue augmentation following flap reconstruction of the face. Twenty of the 23 patients had excellent maintenance of graft volume. An adequately vascularized recipient bed appears to be an important factor in determining ultimate graft survival using our technique. Conclusions Lipotransfer of the head and neck represents a simple, effective adjunctive technique providing for large amounts of readily available, well-tolerated soft tissue filler material. Patient selection is important, specifically in regard to determining that there is adequate vascularity of the recipient bed. [source]


    Adult Living Liver Donors have Excellent Long-Term Medical Outcomes: The University of Toronto Liver Transplant Experience

    AMERICAN JOURNAL OF TRANSPLANTATION, Issue 2 2010
    L. Adcock
    Right lobe living donor liver transplantation is an effective treatment for selected individuals with end-stage liver disease. Although 1 year donor morbidity and mortality have been reported, little is known about outcomes beyond 1 year. Our objective was to analyze the outcomes of the first 202 consecutive donors performed at our center with a minimum follow-up of 12 months (range 12,96 months). All physical complications were prospectively recorded and categorized according to the modified Clavien classification system. Donors were seen by a dedicated family physician at 2 weeks, 1, 3 and 12 months postoperatively and yearly thereafter. The cohort included 108 males and 94 females (mean age 37.3 ± 11.5 years). Donor survival was 100%. A total of 39.6% of donors experienced a medical complication during the first year after surgery (21 Grade 1, 27 Grade 2, 32 Grade 3). After 1 year, three donors experienced a medical complication (1 Grade 1, 1 Grade 2, 1 Grade 3). All donors returned to predonation employment or studies although four donors (2%) experienced a psychiatric complication. This prospective study suggests that living liver donation can be performed safely without any serious late medical complications and suggests that long-term follow-up may contribute to favorable donor outcomes. [source]


    Long-term results of a combination of paclitaxel, cisplatin and gemcitabine for salvage therapy in male germ-cell tumours

    BJU INTERNATIONAL, Issue 3 2009
    Nicola Nicolai
    OBJECTIVE To retrospectively review the long-term activity, efficacy and toxicity of the combination of paclitaxel, cisplatin and gemcitabine (TPG) as third- or further-line chemotherapy in patients with germ-cell tumours (GCTs) who are not cured after at least two courses of standard-dose chemotherapy, high-dose chemotherapy or both. PATIENTS AND METHODS We evaluated 22 consecutive men treated between April 1999 and December 2000. Half of them were classified as absolutely refractory to cisplatin and a further two as refractory. The median (range) number of previous courses of chemotherapy was 8 (5,11). Treatment consisted of paclitaxel 80 mg/m2, cisplatin 50 mg/m2 and gemcitabine 800 mg/m2 on days 1 and 8, every 3 weeks for four courses, followed by surgery of actual residual resectable masses. RESULTS The follow-up was updated at August 2007. There were no deaths from toxicity and only one patient needed suspension of therapy for toxicity. There was both grade 3,4 thrombocytopenia and neutropenia in 15 patients (68%), and anaemia in nine (41%). There were partial remissions in eight (36%) patients. Six (27%) patients were rendered disease-free with surgical removal of a residual mass after chemotherapy (two still containing viable cancer). Four (18%) patients are long-term survivors at more than 80, 81, 94 and 99 months. The median (range) overall survival of the whole series was 13.5 (1,>99) months. CONCLUSION This combination had a toxicity profile that was acceptable and comparable with other third-line regimens. There were eight (36%) major responses. After a 6-year minimum follow-up, four (18%) patients were long-term disease-free survivors. [source]


    Salvage robotic-assisted radical prostatectomy: initial results and early report of outcomes

    BJU INTERNATIONAL, Issue 7 2009
    Ronald S. Boris
    OBJECTIVE To evaluate the initial results of salvage robotic-assisted radical prostatectomy (SRARP) after recurrence following primary radiotherapy (RT) for localized prostate cancer. PATIENTS AND METHODS Between December 2002 and January 2008, 11 patients had SRARP with pelvic lymph node dissection by one surgeon from one institution. Six patients had brachytherapy, three had external beam RT (EBRT), one intensity-modulated RT, and one received brachytherapy with an EBRT boost. All patients had prostate cancer on biopsy after RT, with negative computed tomography and bone scan. The mean (range) follow-up was 20.5 (1,77) months. RESULTS The mean interval from RT to SRARP was 53.2 months; the mean preoperative prostate-specific antigen (PSA) level was 5.2 ng/mL, the operative duration 183 min and the estimated blood loss 113 mL. One patient had prolonged lymphatic drainage, one had an anastomotic leak, and one had an anastomotic stricture requiring direct vision internal urethrotomy at 3 months. The mean duration of catheterization was 10.4 days and the hospital stay 1.4 days. Three patients had a biochemical recurrence, at 1, 2 and 43 months. In one of two patients with node-positive carcinoma of the prostate the PSA level failed to reach a nadir of zero after surgery. In patients with a minimum follow-up of 2 months, eight of 10 are continent (defined as zero to one pad per day) and two have erections adequate for intercourse with the use of phosphodiesterase-5 inhibitors. CONCLUSION SRARP after RT-resistant disease recurrence is feasible with minimal perioperative morbidity. Early functional outcomes appear to be at least equivalent with historical salvage RP series. Robotic extended pelvic lymph node dissection is safe and can improve the accuracy of surgical staging. A longer follow-up is necessary to better assess the functional and oncological outcomes. [source]


    Short-term outcome after high-intensity focused ultrasound in the treatment of patients with high-risk prostate cancer

    BJU INTERNATIONAL, Issue 6 2006
    Vincenzo Ficarra
    OBJECTIVE To assess the short-term outcome in patients with high-risk prostate cancer treated by transrectal high-intensity focused ultrasound (HIFU). PATIENTS AND METHODS From April 2003 to November 2004, 30 patients with high-risk prostate cancer were enrolled in this prospective study; all had transurethral resection of the prostate before transrectal HIFU treatment, using the Ablatherm device (EDAP, Lyon, France) during the same session, associated with hormonal therapy with luteinizing hormone-releasing hormone analogues. After the procedure, all the patients were evaluated every 3 months by physical examination, prostate-specific antigen (PSA) assay and a continence questionnaire. The follow-up schedule also included a transperineal prostate biopsy 6 months after the treatment. All the patients had a minimum follow-up of 12 months. RESULTS The HIFU treatment took a median (interquartile range, IQR) of 140 (100,160) min. No complications were reported during treatment. The mean (IQR) hospitalization was 2.2 (1,4) days, and the suprapubic drainage tube was removed after 12 (7,18) days. The complications after treatment were: urinary tract infections in five patients (16%), stenosis of the intraprostatic and membranous urethra in three (10%), and secondary infravesical obstruction in four (13%). At 12 months after the procedure, 28 patients (93%) were continent. Seven of the 30 men (23%) had a positive prostate biopsy. At the 1-year follow-up only three of the 30 patients with high-risk prostate cancer had a PSA level of >0.3 ng/mL. CONCLUSIONS HIFU is a modern, minimally invasive therapy for prostate cancer, often used in selected patients with localized disease. The present results show that HIFU was also feasible in patients with high-risk prostate cancer. The low complication rates and favourable functional outcome support the planning of further larger studies in such patients. The oncological efficacy of HIFU should be assessed in further studies with a longer follow-up. [source]


    Dasatinib 100 mg once daily minimizes the occurrence of pleural effusion in patients with chronic myeloid leukemia in chronic phase and efficacy is unaffected in patients who develop pleural effusion,

    CANCER, Issue 2 2010
    Kimmo Porkka MD
    Abstract BACKGROUND: Dasatinib, a highly potent BCR-ABL inhibitor, is an effective treatment for patients with chronic myeloid leukemia in chronic phase (CML CP) after resistance, suboptimal response, or intolerance to prior imatinib. In a phase 3 dose optimization trial in patients with CML CP (CA180-034), the occurrence of pleural effusion was significantly minimized with dasatinib 100 mg once daily (QD) compared with other treatment arms (70 mg twice daily [twice daily], 140 mg QD, or 50 mg twice daily). METHODS: To investigate the occurrence and management of pleural effusion during dasatinib treatment, and efficacy in patients with or without pleural effusion, data from CA180-034 were analyzed. RESULTS: With 24-month minimum follow-up, 14% of patients treated with dasatinib 100 mg QD incurred pleural effusion (grade 3: 2%; grade 4: 0%) compared with 23% to 26% in other study arms. The pleural effusion rate showed only a minimal increment from 12 to 24 months. In the 100 mg QD study arm, median time to pleural effusion (any grade) was 315 days, and after pleural effusion, 52% of patients had a transient dose interruption, 35% had a dose reduction, 57% received a diuretic, and 26% received a corticosteroid. Three patients in the 100 mg QD study arm discontinued treatment after pleural effusion. Across all study arms, patients with or without pleural effusion demonstrated similar progression-free and overall survival, and cytogenetic response rates were higher in patients with a pleural effusion. CONCLUSIONS: Pleural effusion is minimized with dasatinib 100 mg QD dosing and its occurrence does not affect short- or long-term efficacy. Cancer 2010. © 2010 American Cancer Society. [source]


    Response measurement after intraarterial chemoradiation in advanced head and neck carcinoma

    CANCER, Issue 8 2006
    Magnetic resonance imaging, evaluation under general anesthesia?
    Abstract BACKGROUND The objectives of this prospective trial were to evaluate the diagnostic accuracy and predictive value of magnetic resonance imaging (MRI) and to use MRI evaluation under general anesthesia (EGA) 6 to 8 weeks after chemoradiation to determine local control. METHODS Eighty-two consecutive patients with advanced-stage squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx were treated with selective targeted chemoradiation. All patients who completed treatment and survived had a minimum follow-up of 3 years. MRI and EGA were performed from 6 to 8 weeks after treatment. Posttreatment MRI findings were compared with pretreatment MRI findings and were graded for risk of local recurrence/residual disease on a 4-point scale. The diagnosis of treatment failure was based on tissue biopsies, which were obtained during EGA or later during follow-up. The predictive value of MRI was analyzed by using a Cox proportional hazards model. RESULTS Only 1 patient with MRI Grade 0 or 1 findings (discrete mass < 10 mm; n = 62 patients) had residual disease 6 to 8 weeks after treatment that was detected during EGA. In 5 patients with MRI findings of Grade 2a and 2b (mass > 10 mm; n = 20 patients), residual disease was detected. After 2 years, 23 patients had a local failure (28%). Twelve local failures were found among 62 patients who had MRI findings of Grade 0 and 1. Posttreatment MRI emerged as an independent predictive factor (hazard ratio, 3.0; P = .014) for local control. CONCLUSIONS Posttreatment MRI studies provided predictive information on local control in addition to pretreatment predictors. In patients with focal masses < 10 mm, the combination of response evaluation under general anesthesia and posttreatment MRI from 6 to 8 weeks after chemoradiation hardly provided more information on the local control than posttreatment MRI alone. Cancer 2006. © 2006 American Cancer Society. [source]


    An interinstitutional and interspecialty comparison of treatment outcome data for patients with prostate carcinoma based on predefined prognostic categories and minimum follow-up,

    CANCER, Issue 10 2002
    Frank A. Vicini M.D.
    Abstract BACKGROUND The optimal management of patients with clinically localized prostate carcinoma remains undefined due in part to the absence of well-designed, prospective, randomized trials. The current study was conducted to compare and contrast outcomes with different forms of therapy for patients with prostate carcinoma who were treated at several institutions using predefined prognostic categories. METHODS A retrospective study of 6877 men with prostate carcinoma who were treated between 1989 and 1998 at 7 different institutions with 6 different types of therapy was conducted. Five-year actuarial rates of prostate specific antigen (PSA) failure were calculated based on predefined prognostic categories, which included combinations of pretreatment PSA level, tumor stage, and Gleason score. In addition, outcome was calculated using consistent biochemical failure definitions and a minimum, median length of follow-up. RESULTS Substantial differences in outcome were observed for the same type of treatment and at the same institution, depending on the number of prognostic variables used to define treatment groups. However, estimates of 5-year PSA outcomes after all forms of therapy for low-risk and intermediate-risk patient groups were remarkably similar (regardless of the type of treatment) when all three pretreatment variables were used to define prognostic categories. For patients in high-risk groups, the 5-year PSA outcomes were suboptimal, regardless of the treatment technique used. CONCLUSIONS The current data suggest that interinstitutional and interspecialty comparisons of treatment outcome for patients with prostate carcinoma are possible but that results must be based on all major prognostic variables to be meaningful. Analyzed in this fashion, 5-year PSA results were similar for patients in low-risk and intermediate-risk groups, regardless of the form of therapy. Findings from prospective, randomized trials using survival (cause specific and overall) as the end point for judging treatment efficacy and longer follow-up will be needed to validate these findings and to identify the most appropriate management option for patients with all stages of disease. Cancer 2002;95:2126,35. © 2002 American Cancer Society. DOI 10.1002/cncr.10919 [source]


    Baerveldt glaucoma implants in the management of refractory glaucoma after vitreous surgery

    ACTA OPHTHALMOLOGICA, Issue 1 2010
    Elisabeth Van Aken
    Abstract. Purpose:, To examine the effectiveness and safety of Baerveldt glaucoma implants in eyes with refractory glaucoma following vitrectomy. Methods:, We performed a retrospective study of a non-comparative case series of 30 eyes of 30 patients who had undergone the implantation of a Baerveldt glaucoma device. All eyes (30/30) had a minimum follow-up of 6 months, and 16/30 (53%) had a follow-up of 24 months. Surgical success was defined as intraocular pressure (IOP) < 22 mmHg on the last two follow-up visits with or without glaucoma medication and a decrease in IOP of at least 20% compared to preoperative values with or without glaucoma medication. Results:, The mean IOP before implantation of a Baerveldt glaucoma device was 30 mmHg [± 11.4 mmHg standard deviation (SD)] with maximally tolerated medical therapy. Six months after implantation of the Baerveldt glaucoma device, the mean IOP was 17.3 mmHg (± 6.7 mmHg SD) and the mean number of glaucoma medications had gone down from 3.0 (± 0.4 SD) to 0.3 (± 0.3 SD). Successful outcomes were found in 24 eyes (80%). Small complications occurred in six eyes (20%): transient postoperative hypotony (17%) and tube retraction (3%). Larger complications occurred in another six eyes (20%): corneal decompensation requiring keratoplasty (7%), suprachoroidal haemorrhage (3%) and persistently high IOP (10%). Conclusion:, Baerveldt glaucoma devices are a valid treatment option in eyes with refractory glaucoma after vitreous surgery, although failure occurred in 20% of our patients. Transient complications occurred in 20% and severe complications in another 20%. [source]


    Augmentation procedures for the rehabilitation of deficient edentulous ridges with oral implants

    CLINICAL ORAL IMPLANTS RESEARCH, Issue S2 2006
    Matteo Chiapasco
    Abstract Objectives: To analyze publications related to augmentation procedures and to evaluate the success of different surgical techniques for ridge reconstruction and the survival/success rates of implants placed in the augmented areas. Material and methods: Clinical investigations published in English involving at least 5 patients and with a minimum follow-up of 6 months were included. The following procedures were considered: a) Guided bone regeneration (GBR); 2) Onlay bone grafts; 3) Inlay grafts; 4) Bone splitting for ridge expansion (RE); 5) Distraction osteogenesis (DO); and 6) Revascularized flaps. Success rates of augmentation procedures and related morbidity, as well as survival and success rates of implants placed in the augmented sites were analyzed. Results: Success rates of surgical procedures ranged from 60% to 100% for GBR, from 92% to 100% for onlay bone grafts, from 98% to 100% for ridge expansion techniques, from 96,7% to 100% for DO, and was 87.5% for revascularized flaps, whereas survival rates of implants ranged from 92% to 100% for GBR, from 60% to 100% for onlay bone grafts, from 91% to 97.3% for RE, from 90.4% to 100% for DO, and, finally, was 88.2% for revascularized flaps. Conclusion: On the basis of available data it was shown that it was difficult to demonstrate that a particular surgical procedure offered better outcome as compared to another. The main limit encountered in this review has been the overall poor methodological quality of the published articles. Therefore larger well-designed long term trials are needed. [source]


    A randomized trial of thymoglobulin vs. alemtuzumab (with lower dose maintenance immunosuppression) vs. daclizumab in renal transplantation at 24 months of follow-up

    CLINICAL TRANSPLANTATION, Issue 2 2008
    Gaetano Ciancio
    Abstract: Introduction: A long-term prospective randomized trial evaluating alemtuzumab, a humanized anti-CD52 monoclonal antibody, in a predominantly non-Caucasian population has yet to be reported. Methods: Ninety deceased donor (DD) first renal transplant recipients were randomized into three different antibody induction groups: group A, thymoglobulin (Thymo); group B, alemtuzumab; group C, daclizumab (Dac). In groups A and C, the target trough levels of tacrolimus were 8,10 ng/mL, mycophenolate mofetil (MMF) 1 g administered twice daily, and maintenance methylprednisolone. In group B, target tacrolimus trough levels were 4,7 ng/mL, 500 mg MMF administered twice-daily, without methylprednisolone. African-Americans and Hispanics comprised more than 50% in each group. Results: A minimum follow-up of 27 months showed no overall group differences in patient or graft survival (p = 0.89 and 0.66), but a trend towards worse death-censored graft survival in group B (p = 0.05). Acute rejection rates were not significantly different: six (20%), seven (23%), and seven (23%) in groups A, B, and C, respectively. The incidence of chronic allograft nephropathy was higher in group B than in A and C (p = 0.008). The mean calculated creatinine clearance at 24 months was 81.1 ± 5.5, 64.4 ± 4.5, and 80.7 ± 5.7 in groups A, B, and C, respectively (p = 0.01 for B vs. average of A and C). Conclusion: In this randomized 27-month minimum follow-up trial of predominantly non-Caucasian DD renal transplant recipients with alemtuzumab induction, lower maintenance tacrolimus, MMF, and steroid avoidance appear less effective than either Thymo or Dac with higher maintenance immunosuppression. [source]


    Renal function with delayed or immediate cyclosporine microemulsion in combination with enteric-coated mycophenolate sodium and steroids: results of follow up to 30 months post-transplant

    CLINICAL TRANSPLANTATION, Issue 3 2007
    Georges Mourad
    Abstract:, Background:, In the multicenter, open-label Myriade study, renal transplant patients were randomized to early cyclosporine microemulsion (CsA-ME, day 0) or delayed CsA-ME (day 6) with enteric-coated mycophenolate sodium (EC-MPS), steroids and interleukin-2 receptor induction. One-yr results have been published previously. We now report the results of an extension study in which patients were followed up for a period of three yr post-transplant. Methods:, All patients completing the one-yr core study on-treatment were eligible to enter the extension study. Results:, Of the 203 patients, 153 completed the core trial on-treatment; 144 (94%) entered the extension study with a minimum follow-up of one yr (73 early CsA-ME, 71 delayed CsA-ME). In 75% of patients receiving EC-MPS during the extension, the recommended dose was administered (1440 mg/d). Median creatinine clearance remained constant (57 mL/min) at 12, 24 and 30 months post-transplant and was similar in the early and delayed CsA-ME groups as well as in subpopulations with or without delayed graft function. One patient in the early CsA-ME group died. No grafts were lost. The incidence of BPAR from time of transplant to the end of the extension study was 17% (24/139). Seven patients (5%) discontinued the extension study prematurely because of adverse events. Conclusion:, These results suggest that a regimen of CsA-ME, EC-MPS and steroids results in excellent survival rates with stable renal function over a mean follow-up of 30 months. Immediate introduction of CsA-ME has no deleterious effect on long-term renal function, even among patients with delayed graft function. [source]


    L/I-7 Comparison of HCV outcomes in recipients of expanded-criteria, living donor, and standard liver grafts

    CLINICAL TRANSPLANTATION, Issue 2006
    M. Kinkhabwala
    Introduction:, Living donor (LD) and expanded-criteria donor (ECD) livers are important sources of organ transplants in some regions. Hepatitis C virus (HCV) remains the most common reason for end-stage liver disease in the United States. It is unclear whether ECD and LD grafts are associated with poorer outcomes in hepatitis C recipients, as compared with non-ECD (standard [STD]) MELD-allocated livers. The aim of this retrospective study was to compare long-term hepatitis C recurrence rates and outcomes in recipients of ECD, LD, and STD grafts. Methods:, The cohort of patients analyzed comprised all adult hepatitis C transplant recipients between 1/1/01 and 11/1/04 (minimum follow-up, 1 year). Recipients not surviving the immediate perioperative period (90 days) were excluded. Censored events were defined by disease-free graft survival. Disease recurrence was defined by histologically confirmed hepatitis C and at least stage II fibrosis. ECDs were identified according to accepted criteria (e.g., age, steatosis, ischemia, donation after cardiac death, abnormal biopsy). Results:, In all, 120 patients formed the study cohort, with 79 ECD, 27 LD, and 14 STD grafts. The mean recipient MELD was 19.8 overall (range, 6 to 43), 20.1 (ECD), 14.1 (LD), and 24.7 (STD). The mean time to censored event was 709 days overall, 631 (ECD), 884 (STD), and 846 (LD). The 2-year disease-free survival rate was 44% (ECD), 55.6% (LD), and 70.7% (STD), by Kaplan-Meier analysis. Comparison of the curves indicated a significant difference between ECD and STD recipients, but no difference between ECD and LD recipients. Conclusions:, Recipients with hepatitis C who received ECD grafts had poorer outcomes in our experience, as compared with those receiving STD grafts. LD grafts, which can be viewed as a subset of ECD grafts, also had poorer outcomes than STD whole grafts, but this difference was not statistically significant. [source]