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Prospective Protocol (prospective + protocol)
Selected AbstractsThe effect of intestinal urinary reservoirs on renal function: a 10-year follow-upBJU INTERNATIONAL, Issue 3 2000E. Fontaine Objective To study the effect of the storage of urine in intestinal reservoirs on long-term renal function and the possible causes of deterioration. Patients and methods Eighty-seven patients (aged 4,35 years) with bladder exstrophy who underwent reconstruction of the lower urinary tract using a bowel segment were enrolled in a prospective protocol. The glomerular filtration rate (GFR) was measured before and after surgery at 1, 2, 5 and 10 years using 51Cr-ethylenediamine tetra-acetic acid. Patients with a decline in GFR of > 5% were investigated to identify the cause. Results Of 58 patients with a follow-up of , 10 years, 53 were evaluable, four having been lost to follow-up and one refusing to accept the protocol. In these 53 patients, the mean ( sd) GFR decreased from 97.9 (20.4) to 92.9 (23.6) mL/min/1.73 m2 (P = 0.24). However, this decrease was accounted for by 10 patients (19%) whose GFR fell by ,,20% over the 10 years. The causes of renal deterioration in these 10 patients were; chronic retention and/or infection caused by inadequate catheterization in poorly compliant patients (five), uretero-ileal stenosis (one), a high-pressure reservoir (one) and uncertain causes (three). Conclusions For 80% of the patients, the storage of urine in intestinal reservoirs did not change renal function for at least 10 years. However, ,,20% of patients had some deterioration in renal function during the 10-year follow-up, usually from identifiable and remediable causes. The storage of urine in bowel does not appear to be inherently damaging to kidney function. Patients with an enterocystoplasty need regular monitoring of renal function; when deterioration is detected the urinary tract must be functionally assessed. [source] Outcome of protracted hypoparathyroidism after total thyroidectomyBRITISH JOURNAL OF SURGERY (NOW INCLUDES EUROPEAN JOURNAL OF SURGERY), Issue 11 2010A. Sitges-Serra Background: Although the variables that influence the development of post-thyroidectomy hypocalcaemia are now better understood, the risk factors and long-term outcome of persistent hypoparathyroidism (HPP) are poorly defined. A retrospective review of a prospective protocol for the management of post-thyroidectomy hypocalcaemia was performed. Methods: Patients with a serum calcium level below 8 mg/dl (2 mmol/l) 24 h after total thyroidectomy were prescribed oral calcium with or without calcitriol and followed for at least 1 year. Protracted HPP was defined as an intact parathyroid hormone (iPTH) level below 13 pg/ml and need for calcium medication at 1 month after thyroidectomy. Results: Of 442 patients (343 with goitre, 99 with carcinoma) undergoing total thyroidectomy, 222 (50·2 per cent) developed postoperative hypocalcaemia. Eleven patients were lost to follow-up. Parathyroid function recovered in 131 patients within 1 month and 80 developed protracted HPP, which was associated with lymphadenectomy, fewer than three glands left in situ and incidental parathyroidectomy. Parathyroid function recovered within 1 year in 78 per cent of patients with protracted HPP. Factors associated with late recovery of parathyroid function were higher serum calcium and low but detectable iPTH levels 1 month after surgery. These factors were associated with higher calcitriol and calcium dosages at hospital discharge. Parathyroid autotransplantation did not protect against permanent HPP. Conclusion: Higher serum calcium levels at 1 month after total thyroidectomy are associated with recovery of parathyroid function. It is hypothesized that intensive medical treatment of hypocalcaemia,,parathyroid splinting',may improve the outcome of patients with protracted HPP. Copyright © 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. [source] A prospective pilot study of curative-intent stereotactic body radiation therapy in patients with 5 or fewer oligometastatic lesions,CANCER, Issue 3 2008Michael T. Milano MD Abstract BACKGROUND. It is hypothesized that oligometastatic disease represents a state of potentially curable, limited metastases. Stereotactic body radiation therapy (SBRT) is an option for patients who are not amenable to or do not want resection. METHODS. From 2001 to 2006, 121 patients with ,5 detectable metastases were enrolled in 2 prospective studies that used curative-intent SBRT. Most patients were treated with 10 fractions of 5 Gray. Stereotactic radiosurgery was offered to patients with brain metastases. RESULTS. The 2-year overall survival (OS), progression-free survival (PFS), local control (LC), and distant control (DC) rates were 50%, 26%, 67%, and 34%, respectively; and the respective 4-year rates values were 28%, 20%, 60%, and 25%. A greater net tumor volume predicted significantly worse OS, PFS, LC, and DC. Patients with breast cancer fared significantly better with respect to OS, PFS, LC, and DC; and patients with adrenal metastases had significantly worse OS, PFS, and DC despite the small number of such patients enrolled. Neither the number of metastatic lesions nor the number of organs involved was a significant predictor of outcome. Among 45 patients who remained alive at the last follow-up, 29 patients had no evidence of disease, including 23 patients with ,2 years of follow-up. CONCLUSIONS. Oligometastatic disease is a potentially curable state of distant cancer spread. In this hypothesis-generating analysis, patients with less volume burden of their metastatic disease and those with primary breast cancer fared better. SBRT delivered with curative intent in patients with limited metastases should be investigated further. The Southwest Oncology Group is developing a prospective protocol to treat women who have limited breast cancer metastases with SBRT. Cancer 2008. © 2007 American Cancer Society. [source] A prospective study of concurrent cyclophosphamide/methotrexate/5-fluorouracil and reduced-dose radiotherapy in patients with early-stage breast carcinomaCANCER, Issue 7 2004Jennifer R. Bellon M.D. Abstract BACKGROUND Concurrent administration of chemotherapy and radiotherapy has the potential advantage of delaying neither treatment and providing radiation sensitization. However, the optimal approach to concurrent treatment in women with early-stage breast carcinoma remains undefined. We present updated results of a prospective protocol of concurrent cyclophosphamide/methotrexate/5-fluorouracil (CMF) and reduced-dose radiotherapy, focusing on tumor control and patient tolerance. METHODS One hundred twelve women with AJCC Stage I or Stage II breast carcinoma with 0,3 positive axillary lymph nodes were enrolled in a prospective single-arm study of concurrent CMF and reduced-dose radiotherapy (39.6 gray [Gy] to the whole breast, 16-Gy boost). A high proportion of women had risk factors associated with an increased risk of local disease recurrence, including age < 40 (32%), close or positive margins (37%), or lymphatic/vascular invasion (51%). The median follow-up period was 94 months. RESULTS The 5-year overall survival rate was 94%. By 60 months, 5 patients (4%) experienced local disease recurrence and 19 patients (17%) experienced distant metastasis. There were no isolated regional lymph node recurrences. Local disease recurrence occurred in 1 of 25 patients (4%), 1 of 16 patients (6%), and 3 of 70 patients (4%) with positive, close (< 1 mm), and negative margins, respectively. One patient developed acute myelogenous leukemia. An additional patient developed Grade 2 pneumonitis. Cosmetic results were not recorded uniformly for all patients and therefore could not be reliably analyzed. CONCLUSIONS Concurrent CMF and reduced-dose radiotherapy resulted in a low level of late toxicity and excellent local tumor control, despite the large proportion of patients with substantial risk factors for local disease recurrence. Future studies of concurrent regimens, particularly in patients at high risk of local disease recurrence, are warranted. Cancer 2004;100:1358,64. © 2004 American Cancer Society. [source] Coronary stent assessability by 64 slice multi-detector computed tomographyCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 2007Tej Sheth MD Abstract Background: We evaluated the assessability of contemporary stent platforms by 64-slice multi-detector computed tomography (MDCT). Methods. Patients undergoing coronary stenting were included in a prospective protocol of MDCT imaging within 48 hr of stent implantation. MDCT data were acquired using a "Sensation 64" MDCT scanner (Siemens Medical Solutions, Forchheim, Germany). Stent assessability was assessed by two independent blinded observers and disagreement was resolved by a third observer. Assessability was defined at visualization of the in-stent lumen without influence of partial volume effects, beam hardening, motion, calcification, or contrast to noise limitations. Results: Fifty four stents (Cypher n = 25, Vision/Minivision n = 19, Taxus Express n = 8, Liberte n = 1, Driver n = 1) in 44 patients were included in the study. The two independent observers classified 30 of 54 stents (56%) as assessable. Interobserver reproducibility was good with , = 0.66. Stent size was the most important determinant of assessability. Consistently assessable stents were 3.0 mm or larger (85%), whereas those under 3 mm were mostly nonassessable (26%).Conclusions: Contemporary stent designs evaluated on a 64-slice MDCT scanner showed artifact free assessability only in larger stents. Increase in spatial resolution of MDCT scanners or modifications in stent design will be necessary to noninvasive evaluate stents <3 mm in diameter, where in-stent restenosis is more frequent. © 2007 Wiley-Liss, Inc. [source] | ||||||||||