Impact of Surgical Technique on Long-term Complication Rate After Laparoscopic Adjustable Gastric Banding (LAGB): Results of a Single-blinded Randomized Controlled trial (ANOSEAN Study).

OBJECTIVE: The aim of the study was to explore the impact of the absence of band fixation on the reoperation rate and to identify other risk factors for long-term complications. BACKGROUND: Laparoscopic adjustable gastric banding has been demonstrated to permit important weight loss and comorbidity improvement, but some bands will have to be removed mainly for failure or in case of planned 2-step surgery. Then, the absence of a gastro-gastric suture (GGS) would allow easier band removal. There are insufficient data to conclude that GGS should be abandoned, as the associated risk of band slippage has not been prospectively assessed. METHODS: The ANOSEAN study was a randomized controlled single-blind trial (CPP 2009-A00346-51). Primary outcome was reintervention rate for band removal or repositioning at 3 years. It included 706 patients in 17 bariatric centers. Patients in group 1 received a gastric band with GGS. Inclusion criteria were adapted from National Institutes of Health recommendations. Surgical technique was standardized among all surgeons. RESULTS: At 3 years, the reintervention rate for band retrieval or repositioning was significantly higher in the absence of band fixation (19.4% vs11.3%; P = 0.013), partly because of the slippage rate (10.3% vs 3.6%; P = 0.005). Body mass index <40 kg/m at baseline was also an independent risk factor of slippage (odds ratio 2.769, 95% confidence interval 1.373, 5.581). CONCLUSIONS: GGS prevents band slippage and lower reintervention rate at 3 years. Fixation could be discussed for patients with high BMI who are scheduled to undergo 2-step surgery, but it needs to be specifically assessed.

Early prediction of failure to lose weight after obesity surgery.

BACKGROUND: After Roux-en-Y gastric bypass (RYGB), failing to lose enough weight or regaining weight is a concern for both patients and healthcare professionals. Our objective was to report the criteria for an early prediction of the failure to lose enough weight in the setting of a private practice and an academic center of obesity surgery. PATIENTS AND METHODS: A retrospective analysis of the 2-year weight loss profiles of patients after RYGB was performed using nonlinear mixed models. A total of 375 morbidly obese adult patients, with a body mass index of 49.3 ± 7.7 kg/m(2), were included. Weight loss success was determined 2 years after surgery using the percentage of excess weight loss criteria. The surgical treatment and the main outcome measurement was standardized RYGB and the percentage of excess weight loss time profiles. RESULTS: The patients who failed, succeeded, or had intermediate results at 2 years after surgery had different percentage of excess weight loss profiles during this period. At 6 months, 71% of those who had lost <30% of their initial excess weight had not lost ≥50% at 24 months. In contrast, those who had lost >45% were unlikely to have lost <50% of their excess weight. CONCLUSION: An early (month 6) prediction of failure to lose significant weight after RYGB can be made, with the threshold at 30% of the initial excess weight loss. Patients who have lost <30% of their initial excess weight are unlikely to have lost ≥50% at 24 months.

Continuous glucose monitoring after islet transplantation in type 1 diabetes: an excellent graft function (ß-score greater than 7) Is required to abrogate hyperglycemia, whereas a minimal function is necessary to suppress severe hypoglycemia (ß-score greater than 3).

CONTEXT: For the last 10 yr, continuous glucose monitoring (CGM) has brought up new insights into the accuracy of blood glucose analysis. OBJECTIVE: Our objective was to determine how islet graft function was able to influence the various components of dysglycemia after islet transplantation (IT). DESIGN AND SETTING: We conducted a single-arm open-labeled study with a 3-yr follow-up in a referral center (ClinicalTrial.gov identifiers NCT00446264 and NCT01123187). PATIENTS: Twenty-three consecutive patients with type 1 diabetes (14 islet alone, nine islet after kidney) received IT within 3 months using the Edmonton protocol. INTERVENTION: INTERVENTION included 72-h CGM before and 3, 6, 9, 12, 24, and 36 months after transplantation. MAIN OUTCOME MEASURE: Graft function was estimated via ß-score, a previously validated index (range 0-8) based on treatment requirements, C-peptide, blood glucose, and glycated hemoglobin. RESULTS: At the 3-yr visit, graft function persisted in 19 patients (82%), and 10 (43%) remained insulin independent. Glycated hemoglobin decreased in the whole cohort from 8.3% (7.3-9.0%) at baseline to 6.7% (5.9-7.7%) at 3 yr [median (interquartile range), P < 0.01]. Mean glucose, glucose sd, and time spent with glycemia above 10 mmol/liter (hyperglycemia) and below 3 mmol/liter (hypoglycemia) were significantly lower after IT (P < 0.05 vs. baseline). The four CGM outcomes were related to ß-score (P < 0.001). However, partial function (ß-score >3) was sufficient to abrogate hypoglycemia; suboptimal function (ß-score >5) was necessary to significantly improve mean glucose, glucose sd, and hyperglycemia; and optimal function (ß score >7) was necessary to normalize them. CONCLUSION: The four components of dysglycemia were not equally affected by the degree of islet graft function, which could have important implications for future development of ß-cell replacement. A ß-score above 3 dramatically reduced the occurrence of hypoglycemia.

Renal origin and size are independent predictors of survival after surgery for adrenal metastasis.

BACKGROUND: The adrenal gland is a frequent site of dissemination for certain types of tumors. Aggressive treatment remains controversial. The benefit of adrenalectomy has been observed, but the ultimate role remains to be elucidated. MATERIALS AND METHODS: We conducted a retrospective study analyzing the records of all patients with adrenal metastases submitted to adrenalectomy (open or laparoscopic) at our institution from 1981 to 2010. Baseline characteristics, operative outcomes, and survival were analyzed; predictive factors were also studied by multivariate analysis. RESULTS: A total of 65 patients were included with a median age of 60 years. Primary tumor sites were renal (35%), pulmonary (23%), melanoma (7%), colon (2%), liver (1%), and others. Mean metastasis size was 7 ± 4.2 cm with a mean interval to metastasis diagnosis of 39 months. Laparoscopic approach was done in 50% of cases. Postoperative morbidity was present in 9%, and 2 early deaths were observed. Median overall survival was 48 months and 45% at 5 years. Univariate and multivariate analyses showed better prognosis for renal metastases (p = 0.007 and 0.009) and those with size <5 cm (p = 0.011 and 0.031). Also in univariate analysis: synchronous (p = 0.02), symptomatic (p = 0.04), and laparoscopically operated (p = 0.033) metastasis showed higher survival rates. Metastasis from pulmonary tumors had the worst prognosis. CONCLUSIONS: Adrenalectomy should be considered in patients with adrenal metastasis from renal carcinoma, as well as in those with small secondary lesions from other type of tumor with a controlled primary disease. The clear benefit of adrenalectomy remains to be documented in pulmonary carcinoma metastasis.

Preoperative weight loss with intragastric balloon decreases the risk of significant adverse outcomes of laparoscopic gastric bypass in super-super obese patients.

BACKGROUND: Extreme obesity increases morbi-mortality in bariatric surgery. We previously showed that significant weight loss can be obtained within 3 months in super-super obese patients (BMI > 60 kg/m(2)) with an intragastric balloon (IGB). Here, we explored the potential benefit of preoperative IGB on the outcome of laparoscopic gastric bypass (LGBP) in super-super obese patients. METHODS: In this case-control study, we compared the records of 60 consecutive super-super obese patients (66.5 ± 3.4 kg/m(2)) submitted to a LGBP between 2004 and 2009, with preoperative IGB (n = 23, cases) or without (n = 37, controls). We analyzed the clinical outcome of surgery and a composite end point of significant adverse events defined as the presence of at least one of the following conditions: conversion to laparotomy, intensive care unit stay for more than 2 days, and overall hospital stay superior to 2 weeks. RESULTS: All baseline clinical and biological characteristics were homogenous between both groups. IGB was maintained during 155 ± 62 days and induced a loss of 5.5 ± 1.3 kg/m(2) (11.2 ± 3.2% of excess body mass index) at the time of LGBP, associated with a decrease in systolic blood pressure and gamma-glutamyl transpeptidase level (p < 0.05 vs. baseline). Operative time was lower in the IGB group (146 ± 47 vs. 201 ± 81 min in controls; p < 0.01). Significant adverse events occurred less frequently after LGBP in the IGB group (2 vs. 13 in controls; p < 0.05). All patients were alive at 1 year and overall weight loss was similar in both groups (52.4 ± 17.3 vs. 50.3 ± 12.7 percent of excess BMI loss in controls; NS). CONCLUSIONS: IGB prior to LGBP in super-super obese patients significantly reduced excess BMI. It was associated with a shorter operative time and a lower overall risk of significant adverse outcomes.

Validation of noninvasive biomarkers (FibroTest, SteatoTest, and NashTest) for prediction of liver injury in patients with morbid obesity.

BACKGROUND: Liver biopsy is considered as the gold standard for assessing nonalcoholic fatty liver disease (NAFLD) histologic lesions in patients with morbid obesity. The aim of this study was to determine the diagnostic utility of noninvasive markers of fibrosis (FibroTest), steatosis (SteatoTest), and steatohepatitis (NashTest, ActiTest) in these patients. MATERIALS AND METHODS: Two hundred and eighty-eight patients presenting with interpretable baseline operative biopsy and biomarkers, in an ongoing prospective cohort of patients treated with bariatric surgery, were included. Histology (NAFLD activity score, or NAFLD scoring system) and biochemical measurements were centralized and blinded to other characteristics. The area under the receiver operating characteristic curves (AUROC), sensitivity, specificity, positive and negative predictive values were assessed. Weighted AUROC (Obuchowski method) was used to prevent multiple testings and a spectrum effect. RESULTS: The prevalence of advanced fibrosis (bridging) was 6.9%, advanced steatosis (>33%) was 48%, and steatohepatitis was 6.9% (NAFLD scoring system>4). Weighted AUROCs of the tests were as follows (mean, 95% confidence interval, significance): FibroTest for advanced fibrosis: 0.85, 0.83-0.87, P<0.0001; SteatoTest for advanced steatosis: 0.81, 0.79-0.83, P<0.0001; and ActiTest for steatohepatitis: 0.77, 0.73-0.81, P<0.0001. CONCLUSION: In patients with morbid obesity, the diagnostic performances of the FibroTest, SteatoTest, and ActiTest were statistically significant, thereby possibly reducing the need for biopsy in this population.

25-hydroxy vitamin D deficiency causes parathyroid incidentalomas.

PURPOSE: 25-OH D3 (D3) deficiency causes secondary hyperparathyroidism. Asymmetric gland hypertrophy may also lead to unnecessary parathyroid gland resection by mistaking these glands for parathyroid incidentalomas. We tested the hypothesis that D3 deficiency causes parathyroid gland hypertrophy. METHOD: This is a prospective study of 100 consecutive patients undergoing total thyroidectomy. Pre-operative D3 measurement was made at first presentation and on the day after surgery. During thyroidectomy, the parathyroid glands were searched for and measured. Using an ellipsoid volume calculator, the gland volume was calculated. This was correlated with D3 and other possible confounding factors. RESULTS: Normal parathyroid volume is 25.1 mm(3). Parathyroid gland size correlated with D3 levels, p < 0.001. There is a greater asymmetry in gland volume in those patients with the lowest levels of D3 (Spearman's rank correlation coefficient r = -0.51). There was a significant difference in individual gland volume between D3 levels >30 ng/ml and those <30 ng/ml. However, there was no difference in mean gland volume between these groups. There was no difference in correlation according to pathology or thyroid specimen weight. CONCLUSION: There is a significant difference in both individual gland volume and variation in parathyroid gland volume according to D3 levels. Patients with a D3 level <30 ng/ml have a more asymmetrical hyperplasia corresponding with parathyroid incidentalomas. D3 levels should be measured pre-operatively in all patients undergoing total thyroidectomy to avoid unnecessary parathyroid resection.

Upgrading pretransplant human islet culture technology requires human serum combined with media renewal.

BACKGROUND.: The original Edmonton protocol used fresh islets, but for obvious logistic advantages most transplant centers have implemented pretransplant culture in human albumin. The aim of this study was to improve current pretransplant human islet culture techniques. METHODS.: Clinical-grade purified human islets from a total of 24 donors were directly resuspended after isolation in CMRL 1066-based media at 37 degrees C, and media additions and renewal were tested. At days 1 and 5 of culture, in vitro quality controls included islet viability, insulin content and function, apoptosis, and in vivo islet potency assay in nude mice. RESULTS.: Replacing human albumin with human AB serum improved 1- and 5-day preservation of islet function and viability which was further enhanced with antioxidant Stem Ease, leading to the iCulture medium (enriched CMRL: pyruvate, zinc sulfate, insulin, transferrin, selenium, 2.5% human AB serum and Stem Ease). Major damage occurs in the first day of culture and frequent media renewal (25% vol/hr) in this period further improved viability, apoptosis, islet recovery, and function in vitro and in vivo, compared with only changing medium after overnight culture. CONCLUSIONS.: The described human islet culture technique (iCulture medium+renewal) seems to be the best choice for clinical human islet culture when short (1 day) or long (5 days) periods are used. Media choice and dilution play a major role in the function and survival of human islets in culture.

Is thymectomy worthwhile in central lymph node dissection for differentiated thyroid cancer?

BACKGROUND: Clinical guidelines edited in 2006 by the American Thyroid Association (ATA) and stated in the European Thyroid Association Consensus (ETA) recommend routine central lymph node dissection (level VI neck dissection) in addition to thyroidectomy for the surgical treatment of differentiated thyroid cancer. This central dissection increases the incidence of postoperative hypocalcemia, which is related to the resection or devascularization of the inferior parathyroids together with bilateral thymectomy. Some authors perform unilateral thymectomy in order to minimize this complication. Our aim was to study the benefit/risk (incidence of thymic lymph node metastases versus postoperative hypocalcemia) of both procedures. METHODS: We retrospectively reviewed the records of 138 patients who underwent total thyroidectomy with central neck lymph node dissection for differentiated thyroid cancer between 2004 and 2007. Bilateral thymectomy was performed in 45 patients (group 1, 15 males and 30 females) and unilateral thymectomy was performed in 93 patients (group 2, 27 males and 66 females). Forty-two papillary and 3 medullary cancers were found in group 1, and 75 papillary, 2 follicular, and 17 medullary cancers were found in group 2. The presence of thymic metastases at pathology and the occurrence of postoperative hypocalcemia were reviewed. RESULTS: Two cases of papillary thymic metastases were found in group 1. These were lymph node micrometastases localized in the ipsilateral side of the primary tumor in both cases. Transient hypocalcemia was significantly more frequent (P < 0.001) in group 1 than in group 2: 16 patients (35.5%) versus 10 (10.7%). There was one case of permanent hypocalcemia in group 1 after the follow-up period. CONCLUSIONS: Bilateral thymectomy risk outweighs any likely carcinologic benefit. We do not recommend routine bilateral thymectomy during central neck dissection for differentiated thyroid cancer.

Local-regional recurrence of sporadic or syndromic abdominal extra-adrenal paraganglioma: incidence, characteristics, and outcome.

BACKGROUND: Operative excision of abdominal extra-adrenal paragangliomas (EAPs) does not preclude the late development of local-regional recurrence. We describe the incidence, characteristics, and outcome of this rarely reported feature. METHODS: Retrospective analysis of local-regional recurrence that occurred during follow-up of 51 consecutive patients operated for a sporadic (n = 26) or hereditary (n = 25) EAP. RESULTS: Seven patients with a sporadic or syndromic EAP (n = 4: von Hippel-Lindau syndrome and SDHB, SDHC, and SDHD gene mutations) underwent reoperation for a local-regional recurrence after a median time of 46 months (interquartile range [IQR], 16-100). The Kaplan-Meier estimated incidence of local-regional recurrence (+/- standard error of the mean) reached 15% +/- 7% at 5 years and 23% +/- 9% after 10 years. Recurrent EAPs were all secreting and 38% provoked clinical symptoms. New lesions were smaller than the primary EAP (P = .01) and more often associated with lymph node metastases (43% vs 4%, P = .01). Operative excision seemed complete in 5 patients. Clinical remission was maintained in 4 patients after a median follow-up of 57 months (IQR, 22-102). CONCLUSION: Local-regional recurrence of sporadic and syndromic EAPs is frequent and may be delayed beyond 10 years, requiring lifelong follow-up after the initial operation. When technically feasible, operative excision can lead to prolonged remission.

Primary graft function, metabolic control, and graft survival after islet transplantation.

OBJECTIVE To investigate the influence of primary graft function (PGF) on graft survival and metabolic control after islet transplantation with the Edmonton protocol. RESEARCH DESIGN AND METHODS A total of 14 consecutive patients with brittle type 1 diabetes were enrolled in this phase 2 study and received median 12,479 islet equivalents per kilogram of body weight (interquartile range 11,072-15,755) in two or three sequential infusions within 67 days (44-95). PGF was estimated 1 month after the last infusion by the beta-score, a previously validated index (range 0-8) based on insulin or oral treatment requirements, plasma C-peptide, blood glucose, and A1C. Primary outcome was graft survival, defined as insulin independence with A1C < or =6.5%. RESULTS All patients gained insulin independence within 12 days (6-23) after the last infusion. PGF was optimal (beta-score > or =7) in nine patients and suboptimal (beta-score < or =6) in five. At last follow-up, 3.3 years (2.8-4.0) after islet transplantation, eight patients (57%) remained insulin independent with A1C < or =6.5%, including seven patients with optimal PGF (78%) and one with suboptimal PGF (20%) (P = 0.01, log-rank test). Graft survival was not significantly influenced by HLA mismatches or by preexisting islet autoantibodies. A1C, mean glucose, glucose variability (assessed with continuous glucose monitoring system), and glucose tolerance (using an oral glucose tolerance test) were markedly improved when compared with baseline values and were significantly lower in patients with optimal PGF than in those with suboptimal PGF. CONCLUSIONS Optimal PGF was associated with prolonged graft survival and better metabolic control after islet transplantation. This early outcome may represent a valuable end point in future clinical trials.

Prospective study of the long-term effects of bariatric surgery on liver injury in patients without advanced disease.

BACKGROUND & AIMS: Severe obesity is implicated in development of nonalcoholic fatty liver disease (NAFLD). Bariatric surgery induces weight loss and increases survival time of obese patients, but little is known about its effects on liver damage. We performed a 5-year prospective study to evaluate fibrosis and nonalcoholic steatosis (NASH) in severely obese patients after bariatric surgery. METHODS: Bariatric surgery was performed on 381 patients. Clinical and biological data, along with liver biopsies, were collected before and at 1 and 5 years after surgery. RESULTS: Five years after surgery, levels of fibrosis increased significantly, but 95.7% of patients maintained a fibrosis score

Intraperitoneal insulin infusion versus islet transplantation: comparative study in patients with type 1 diabetes.

OBJECTIVE: The purpose of this article was to compare two strategies for insulin delivery in brittle type 1 diabetic patients: intraperitoneal insulin infusion (IPII) through an implantable pump and intraportal islet transplantation (IIT). METHODS: Thirteen consecutive patients (6 islet after kidney and 7 islet transplantation alone), treated with IIT according to the Edmonton protocol, were compared with 17 patients treated with IPII in the same center in a nonrandomized study. Both groups of patients were assessed for clinical profile, metabolic results, and adverse events during the 3-year period after implantation. RESULTS: Sex ratio, mean age, body mass index, diabetes duration, daily insulin need (DIN), blood creatinine, lipid and HbA1c levels, and frequency of diabetic complications did not differ significantly between the two groups before inclusion. The comparison of metabolic results 3, 6, and 12 months after IIT or IPII showed that while mean HbA1c significantly decreased over time in both groups, mean DIN, glycemia, and number of hypoglycemias less than 3.3 mmol/L per patient per week (Hypo) only significantly decreased in the IIT group versus baseline. At 12 months, mean DIN, HbA1c, and Hypo were significantly lower in the IIT versus IPII group. After 24 and 36 months, mean DIN, HbA1c, and Hypo remained significantly lower in the IIT group versus baseline, and mean HbA1c and DIN versus IPII. Adverse events were, however, fourfold more frequent with IIT versus IPII, though their numbers decreased over time. CONCLUSION: These results suggest that metabolic results improve with both methods, but were significantly better with IIT versus IPII, though with more frequent side effects.

Chylothorax: unusual complication after laparoscopic gastric banding.

Laparoscopic adjustable gastric banding is one of the most frequently performed bariatric procedures because of its low operative risk and morbidity. Postoperative chylothorax has never been reported following bariatric surgery. We present the case of a 41-year-old woman who developed a massive right chylothorax after a laparoscopic gastric banding, whose lymphogram showed thoracic duct disruption. Good outcome was achieved after thoracoscopy approach with duct ligation. Although rare, chylothorax is a severe complication, and surgeons must be aware of anatomic landmarks. Chyle leak could be under-diagnosed in postoperative uncomplicated pleural effusions.

Gabapentin attenuates late but not early postoperative pain after thyroidectomy with superficial cervical plexus block.

BACKGROUND: Preoperative oral gabapentin has been shown to reduce postoperative pain. However, the effects of gabapentin as an adjunct to regional anesthesia is unclear and its effects on chronic pain remains unknown. In patients undergoing thyroidectomy, we investigated the effects on early and late (at 6 mo) postoperative pain of preoperative oral gabapentin as an adjunct to superficial cervical plexus block (SCPB). METHOD: Fifty consecutive consenting patients were randomized to receive either 1200 mg of gabapentin (Group G) or placebo (Group P) 2 h preoperatively. Preoperative anxiety was assessed on a numeric scale from 0 to 6. A SCPB was performed after a standardized induction of anesthesia. The primary outcome, analgesic drug consumption, was assessed during the procedure and postoperatively in the postanesthesia care unit and after discharge to the ward. Over the first 24 h, pain levels at rest and during swallowing were measured on a numeric scale from 0 to 10. If the pain level was more than 4/10 at rest, patients received 1 g/6 h of IV paracetamol and/or 50 mg/6 h of IV tramadol as a rescue analgesic treatment in the interval. The day before operation and 6 mo after thyroidectomy, included patients were asked to answer a neuropathic pain diagnostic questionnaire. RESULTS: Population characteristics, preoperative anxiety, intraoperative drug consumption, procedure duration, and postoperative care unit stay were comparable in both groups. Analgesic consumption during the first 24 postoperative hours was similar in both groups (G: 3 [0-5] doses/24 h; P: 3 [1-5] doses/24 h; P = NS), as well as pain at rest (G: 2,2 [0.2-3.7]; P: 2 [0-6.3]; P = NS), and during swallowing (G: 2.8 [0.4-8.9]; P: 3 [1.4-6.3]; P = NS]). Eight patients had a diagnostic questionnaire score more than 3, 6 mo after operation versus 2 in preoperative period (P = 0.04). Such delayed neuropathic pain complaints were reported in seven patients receiving SCPB alone and only in one patient receiving both SCPB and preoperative adjunctive oral gabapentin. (P = 0.01). CONCLUSION: Oral preoperative administration of gabapentin did not modify immediate pain management in thyroidectomy patients receiving SCPB, but prevented delayed neuropathic pain at 6 mo.

Risk factors for lateral cervical lymph node involvement in follicular thyroid carcinoma.

BACKGROUND: Metastases from follicular thyroid carcinoma (FTC) are usually blood borne and far less to lymph nodes (LN). The present study was designed to evaluate the factors that are associated with LN metastases in patients operated on for FTC. METHODS: A retrospective review of 70 patients (25 men; mean age, 47 (range, 14-92) years) operated on between January 1995 and December 2005 for FTC was undertaken. All patients had histopathology study of the regional LN and postoperative radioiodine scintigraphy. According to LN invasion, they were divided into two groups in which various parameters were compared. RESULTS: The length of follow-up was 52 (range 17-108) months. A total of 375 LN were examined from ipsilateral neck side and 87 LN from the contralateral side. LN metastases were found in five (7%) cases: all ipsilateral. Comparing data from the patients with and without LN metastases, respectively, age was 60 and 47 years (p = 0.12), male/female ratio was 1/4 and 24/41 (p = 0.44), tumor size was 68 and 37 mm (p < 0.01), tumor differentiation (well/moderate) was 3/2 and 25/19 (p = 0.89), distant metastases were detected in 1 and 8 cases (p = 0.72) .The tumor size was >40 mm in 35 (50%) patients. All patients with LN metastases were found in this group (5/35; 14%). CONCLUSIONS: Follicular thyroid carcinoma results in metastases to regional lymph nodes in 7% of cases but only to the ipsilateral neck side. Tumor size is the only factor that impacts it. We do not recommend lymph node dissection in follicular thyroid carcinomas <4 cm.

Influence of preservation solution on human islet isolation outcome.

BACKGROUND: The influence of the preservation solution used for in situ perfusion of the donor and pancreas storage on islet isolation has received little attention. METHODS: In this prospective controlled trial, we compared the outcome of human islet isolation from pancreata perfused with University of Wisconsin (UW) solution or Celsior, an alternative colloid-free extracellular solution. RESULTS: At the 1-year interim analysis, the viability and insulin secretion of islets isolated from donors perfused with UW (n=19) or Celsior (n=5) were identical. However, total islet recovery (IEQ) and isolation yield (IEQ/g) were 1.8-fold and 2.1-fold inferior in the Celsior group (P<0.05 vs. UW). Overall, 13 (68%) of islet preparations were effectively transplanted from the UW group vs. none from the Celsior group (P=0.01). The clinical study was discontinued and the causes of these differences were further explored in the pig (n=14). In contrast to UW, Celsior induced cell swelling and pancreas edema after only four hours of cold storage. These abnormalities were delayed when the donor was perfused with Solution de Conservation d'Organes et de Tissus (SCOT), an extracellular solution containing polyethylene glycol. CONCLUSIONS: Our results suggest that colloid-free preservation solutions might be suboptimal for pancreas perfusion and cold storage prior to islet isolation and transplantation. Because pancreata are now frequently recovered for islet transplantation, preliminary experimental and clinical data about islet isolation should be obtained prior to the routine implementation of new preservation solutions for abdominal perfusion during multiorgan recovery.

The evolution of severe steatosis after bariatric surgery is related to insulin resistance.

BACKGROUND & AIMS: In severely obese patients, factors implicated in the evolution of severe steatosis after bariatric surgery remain unresolved. Our aim was to determine whether insulin resistance (IR) influences the histologic effects induced by bariatric surgery. METHODS: We prospectively included 185 severely obese patients (body mass index >/=35 kg/m(2)) referred for bariatric surgery. The evolution of IR (IR index = 1/quantitative insulin sensitivity check index) and liver injury with consecutive biopsy was concomitantly assessed before and 1 year after surgery. RESULTS: At preoperative biopsy, 27% of severely obese patients disclosed severe steatosis (>/=60%). The alanine aminotransferase (P = .01) and IR indexes (P = .04) were independent predictive factors of severe steatosis at baseline. One year after surgery, surgical treatment induced a decrease in body mass index (9.5 kg/m(2); P < .0001), steatosis score (8.5%; P < .0001), and IR index (0.29; P < .0001). The preoperative IR index (P = .01) and preoperative steatosis (P = .006) were independent predictive factors in the persistence of severe steatosis after surgery. Moderate or severe steatosis was more frequently observed in patients who had conserved a higher IR index after surgery than in patients who had improved their IR index (44% vs 20.2%; P = .04). CONCLUSIONS: IR was independently associated with severe steatosis and predicted its persistence after surgery. The amelioration of IR after surgery is associated with a decrease in the amount of fat. Taken together, the results of this prospective study in severely obese patients demonstrate that severe steatosis and its evolution after surgery are intimately connected with IR.

Intragastric balloon for preoperative weight reduction in candidates for laparoscopic gastric bypass with massive obesity.

BACKGROUND: Laparoscopic bariatric operations can be technically challenging in massively obese patients. The potential of the intragastric balloon for preoperative weight reduction was evaluated in candidates for laparoscopic Roux-en-Y gastric bypass (LRYGBP) with super obesity. METHODS: From January 2004 to March 2005, 10 patients with super obesity who were potential candidates for LRYGBP were included in a prospective observational study. An intragastric balloon was placed endoscopically under general anesthesia. Patients were then followed by a multidisciplinary team until removal of the balloon after 6 months. Weight, BMI, and percent excess weight lost (%EWL) were monitored after 1, 3 and 6 months. RESULTS: The 10 patients were all female with mean +/- SD age of 33+/-11 years (range 17-51). Initial weight was 175+/-25 kg (range 135-223) and initial BMI was 64+/-7 kg/m2 (range 59-78). After completion of 1, 3 and 6 months, weight, BMI, and %EWL reached respectively: 166+/-27 kg*, 165+/-27 kg*, and 169+/-26 kg*; 61.1+/-7.6 kg/m2*, 60.8+/-8.4 kg/m2*, and 61+/-8.2 kg/m2*; 9+/-5%, 10+/-7%, 7+/-6%. (*=P<0.01 vs preop). CONCLUSION: In potential candidates for LRYGBP with super obesity, preoperative placement of an intragastric balloon can reduce the excess weight by 10% within 3 months. Extending this period failed to improve these results further.