Implementation and validation of a competency assessment tool for laparoscopic cholecystectomy.

BACKGROUND: Achieving proficiency in a surgical procedure is a milestone in the career of a trainee. We introduced a competency assessment tool for laparoscopic cholecystectomy in our residency program. Our aim was to assess the inter-rater reliability of this tool. METHODS: We included all laparoscopic cholecystectomies performed by residents under the supervision of board certified surgeons. All residents were assessed at the end of the procedure by the supervising surgeon (live reviewer) using our competency assessment tool. Video records of the same procedure were analyzed by two independent reviewers (reviewer A and B), who were blinded to the performing trainee's. The assessment had three parts: a laparoscopic cholecystectomy-specific assessment tool (LCAT), the objective structured assessment of technical skills (OSATS) and a 5-item visual analogue scale (VAS) to address the surgeon's autonomy in each part of the cholecystectomy. We compared the assessment scores of the live supervising surgeon and the video reviewers. RESULTS: We included 15 junior residents who performed 42 laparoscopic cholecystectomies. Scoring results from live and video reviewer were comparable except for the OSATS and VAS part. The score for OSATS by the live reviewer and reviewer B were 3.68 vs. 4.26 respectively (p = 0.04) and for VAS (5.17 vs. 4.63 respectively (p = 0.03). The same difference was found between reviewers A and B with OSATS score (3.75 vs. 4.26 respectively (p = 0.001)) and VAS (5.56 vs. 4.63 respectively; p = 0.004)). CONCLUSION: Our competency assessment tool for the evaluation of surgical skills specific to laparoscopic cholecystectomy has been shown to be objective and comparable in-between raters during live procedure or on video material.

A comparison of the da Vinci Xi vs. the da Vinci Si Surgical System for Roux-En-Y gastric bypass.

PURPOSE: The da Vinci Surgical System family remains the most widely used surgical robotic system for laparoscopy. Data about gastric bypass surgery with the Xi Surgical System are not available yet. We compared Roux-en-Y gastric bypass surgery performed at our institution with the da Vinci Xi and the da Vinci Si Surgical System. METHODS: All robotic gastric bypass procedures performed between January 2013 and September 2016 were analyzed retrospectively. Patient demographics and operative and postoperative outcomes up to 30 days were compared for the da Vinci Xi and Si Surgical System. Robotic costs per procedure were modeled including posts for a standard set of robotic instruments, capital investment, and yearly maintenance. RESULTS: One-hundred forty-four Xi Surgical System and 195 Si Surgical System procedures were identified. Mean age (p = 0.9), gender distribution (p = 0.8), BMI (p = 0.6), and ASA scores (p > 0.5) were similar in both cohorts. Operating room times were similar in both groups (219.4 ± 58.8 vs. 227.4 ± 60.5 min for Xi vs. Si, p = 0.22). Docking times were significantly longer with the Xi compared with the Si Surgical System (9 ± 4.8 vs. 5.8 ± 4 min, p < 0.0001). There was no difference in incidence of minor (13.9 vs. 10.3%, p = 0.3) and major complications (5.6 vs. 5.1%, p = 1 for Xi vs. Si). Costs were higher for the Xi Surgical System caused by higher capital investment and yearly maintenance. CONCLUSIONS: Roux-en-Y gastric bypass surgery can be safely performed with the Xi Surgical System, while drawbacks include longer docking times and higher costs.

Robotic single-site versus multiport laparoscopic cholecystectomy: a case-matched analysis of short- and long-term costs.

BACKGROUND: Multiport laparoscopy is the gold-standard approach for cholecystectomy, and single-port laparoscopy has been developed to further reduce its invasiveness. A specific robotic single-port platform (da Vinci single-site, Intuitive Surgical Inc., Sunnyvale, CA, USA) has been released in 2011, which could technically facilitate single-site cholecystectomy. Current data show its feasibility; however, detailed short- and long-term analyses of costs and comparisons relative to multiport laparoscopy are not available to date. METHODS: Patients who underwent robotic single-site cholecystectomy for benign, clinically noninflammatory disease between 2011 and 2015 were matched for disease, age, gender, BMI, ASA classification, diagnosis, and elapsed year of surgery to a cohort of multiport cholecystectomies. Demographic, perioperative, and long-term data were collected retrospectively and analyzed. Perioperative and long-term costs including re-operations due to the primary procedure until February 2017 were compared across both cohorts. RESULTS: 99 patients who underwent robotic single-site cholecystectomy were matched to 99 patients with multiport cholecystectomy. A higher rate of outpatient procedures in the robotic cohort (31.3 vs. 17.2%, p = 0.0305) was found, and demographic parameters and perioperative clinical outcomes were similar. Perioperative costs were significantly higher for the robotic single-site patients (6158.0 vs. 4288.0 USD, p < 0.0001). With similar follow-up times of 59.0 and 58.9 months, respectively (p = 0.9552), significantly more patients of the robotic Single-Site cohort underwent follow-up surgery (7.1 vs. 0.0%, p = 0.0140), and follow-up costs were significantly higher for the robotic cohort (694.7 vs. 0.0 USD, p = 0.0145). CONCLUSION: With similar early postoperative clinical results and a higher rate of re-operations, perioperative and long-term costs are significantly higher with robotic Single-Site cholecystectomy compared with multiport cholecystectomy. Considering the unclear clinical value of robotic single-site cholecystectomy and the significant short- and long-term costs, a call for further research and a debate as to who should bear the costs beyond the ones of the gold-standard treatment appear reasonable.

Robotic versus laparoscopic stapling during robotic Roux-en-Y gastric bypass surgery: a case-matched analysis of costs and clinical outcomes.

BACKGROUND: The purpose of this analysis is to compare the robotic EndoWrist Stapling System (EWSS) 45 mm (Intuitive Surgical Inc. Sunnyvale, CA, USA) and the ECHELON FLEX™ ENDOPATH® Staplers (EFES) 60 mm (Ethicon, Cincinnati, OH, USA) for gastric pouch formation during robotic gastric bypass surgery. METHODS: Patients who underwent robotic gastric bypass surgery with stapling using EWSS were matched with patients who underwent the same procedure with the EFES. Demographic, intra- and postoperative, and cost data were collected and analyzed. RESULTS: A total of 49 patients were identified who had undergone robotic gastric bypass surgery using EWSS. They were matched with 49 patients who underwent the equivalent procedure using EFES. With similar demographic parameters, corrected operating room time without cholecystectomy took longer for the patients that underwent surgery with EWSS (+22 min, p = 0.1042). Stapler clamping was unsuccessful in 19.0% of all recorded attempts with EWSS. Two intra-operative complications unrelated to stapling and one complication due to stapling were observed in the EWSS cohort, while none was observed for the EFES group. Significantly, more recharges were needed with EWSS to complete the gastric pouch (4.9 vs. 4.1, p = 0.0048) and overall stapling costs for the procedure were significantly higher (2212.2 vs. 1787.4 USD, p = 0.0001). CONCLUSION: Gastric pouch formation using EWSS during robotic gastric bypass surgery is feasible. Due to the shorter length of EWSS compared to EFES, more stapling recharges are required to complete gastric pouch formation and the stapling costs for gastric bypass surgery are higher. Further systematic research should be conducted to precisely determine the value of the robotic EWSS for gastric bypass surgery.

Robotic Gastric Bypass Surgery in the Swiss Health Care System: Analysis of Hospital Costs and Reimbursement.

BACKGROUND: Robotic technology shows some promising early outcomes indicating potentially improved outcomes particularly for challenging bariatric procedures. Still, health care providers face significant clinical and economic challenges when introducing innovations. METHODS: Prospectively derived administrative cost data of patients who were coded with a primary diagnosis of obesity (ICD-10 code E.66.X), a procedure of gastric bypass surgery (CHOP code 44.3), and a robotic identifier (CHOP codes 00.90.50 or 00.39) during the years 2012 to 2015 was analyzed and compared to the triggered reimbursement for this patient cohort. RESULTS: A total of 348 patients were identified. The mean number of diagnoses was 2.7 and the mean length of stay was 5.9 days. The overall mean cost per patients was Swiss Francs (CHF) from 2012 to 2014 that was 21,527, with a mean reimbursement of CHF 24,917. Cost of the surgery in 2015 was comparable to the previous years with CHF 22,550.0 (p = 0.6618), but reimbursement decreased significantly to CHF 20,499.0 (0.0001). CONCLUSIONS: The average cost for robotic gastric bypass surgery fell well below the average reimbursement within the Swiss DRG system between 2012 and 2014, and this robotic procedure was a DRG winner for that period. However, the Swiss DRG system has matured over the years with a significant decrease resulting in a deficit for robotic gastric bypass surgery in 2015. This stipulates a discussion as to how health care providers should continue offering robotic gastric bypass surgery, particularly in the light of developing clinical evidence.

Alloimmune Monitoring After Islet Transplantation: A Prospective Multicenter Assessment of 25 Recipients.

Islet transplantation is an effective treatment for selected patients with type 1 diabetes. However, an accurate test still lacks for the early detection of graft rejection. Blood samples were prospectively collected in four university centers (Geneva, Grenoble, Montpellier, and Strasbourg). Peripheral blood mononuclear cells were stimulated with donor splenocytes in the presence of interleukin-2. After 24 h of incubation, interferon- (IFN-) ELISpot analysis was performed. After a total of 5 days of incubation, cell proliferation was assessed by fluorescence-activated cell sorting (FACS) analysis for Ki-67. Immunological events were correlated with adverse metabolic events determined by loss of 1 point of -score and/or an increased insulin intake 10%. Twenty-five patients were analyzed; 14 were recipients of islets alone, and 11 combined with kidney. Overall, 76% (19/25) reached insulin independence at one point during a mean follow-up of 30.7 months. IFN- ELISpot showed no detectable correlation with adverse metabolic events [area under the curve (AUC)=0.57]. Similarly, cell proliferation analysis showed no detectable correlation with adverse metabolic events (CD3+/CD4+ AUC=0.54; CD3+/CD8+ AUC=0.55; CD3/CD56+ AUC=0.50). CD3/CD56+ cell proliferation was significantly higher in patients with combined kidney transplantation versus islet alone (6 months, p=0.010; 12 months, p=0.016; and 24 months, p=0.018). Donor antigen-stimulated IFN- production and cell proliferation do not predict adverse metabolic events after islet transplantation. This suggests that the volume of transplanted islets is too small to produce a detectable systemic immune response and/or that alloimmune rejection is not the sole reason for the loss of islet graft function.

Robotic single-site combined cholecystectomy and hysterectomy: Advantages and limits.

INTRODUCTION: Robotic single-site surgery (RSS) represents the latest innovation for clinical use of single incision surgery. Several applications have been reported in urology, general surgery and gynecology with potential application in benign cases as well as in oncology. PRESENTATION OF CASE: To further explore potential applications of RSS, we present the first case reported in the literature of combined cholecystectomy and total hysterectomy using the da Vinci Si single-port platform (Intuitive Surgical Inc., Sunnyvale, CA). DISCUSSION: A critical description of the procedure with potential advantages and limitations of the current platform for combined surgical procedure is provided. CONCLUSION: Robotics may facilitate the widespread diffusion of single incision surgery, overcoming current laparoscopic and LESS limitations. However, the available robotic platform still has technical features that will limit its uptake amongst surgeons and further technological development is needed for a wider diffusion of single incision surgery.

Has the gap between pancreas and islet transplantation closed?

Both pancreas and islet transplantations are therapeutic options for complicated type 1 diabetes. Until recent years, outcomes of islet transplantation have been significantly inferior to those of whole pancreas. Islet transplantation is primarily performed alone in patients with severe hypoglycemia, and recent registry reports have suggested that results of islet transplantation alone in this indication may be about to match those of pancreas transplant alone in insulin independence. Figures of 50% insulin independence at 5 years for either procedure have been cited. In this article, we address the question whether islet transplantation has indeed bridged the gap with whole pancreas. Looking at the evidence to answer this question, we propose that although pancreas may still be more efficient in taking recipients off insulin than islets, there are in fact numerous "gaps" separating both procedures that must be taken into the equation. These "gaps" relate to organ utilization, organ allocation, indication for transplantation, and morbidity. In-depth analysis reveals that islet transplantation, in fact, has an edge on whole pancreas in some of these aspects. Accordingly, attempts should be made to bridge these gaps from both sides to achieve the same level of success with either procedure. More realistically, it is likely that some of these gaps will remain and that both procedures will coexist and complement each other, to ensure that ß cell replacement can be successfully implemented in the greatest possible number of patients with type 1 diabetes.

Initial cholecystectomy vs sequential common duct endoscopic assessment and subsequent cholecystectomy for suspected gallstone migration: a randomized clinical trial.

IMPORTANCE: The optimal management of treatment for patients at intermediate risk of a common duct stone (including increased liver function tests but bilirubin <4 mg/dL and no cholangitis) is a matter of debate. Many stones migrate spontaneously into the duodenum, making preoperative common duct investigations unnecessary. OBJECTIVE: To compare strategies of cholecystectomy first vs a sequential endoscopic common duct assessment and cholecystectomy for the management of patients with an intermediate risk of a common duct stone. The main objective was to reduce the length of stay and the secondary objectives were to reduce the number of common duct investigations, morbidity, and costs. DESIGN, SETTING, AND PARTICIPANTS: Interventional, randomized clinical trial with 2 parallel groups performed between June 2011 and February 2013, with a patient follow-up of 6 months. The trial comprised a random sample of 100 adult patients admitted to Geneva University Hospital, Geneva, Switzerland, for acute gallstone-related conditions with an intermediate risk of a common duct stone. Fifty patients were randomized to each group. INTERVENTIONS: Cholecystectomy first with intraoperative cholangiogram for the study group and endoscopic common duct assessment and clearance followed by cholecystectomy for the control group. MAIN OUTCOMES AND MEASURES: Length of initial hospital stay (primary end point), number of common duct investigations and morbidity and mortality within 6 months after initial admission, and quality of life at 1 and 6 months after discharge (EQ-5D-5L [EuroQol Group, 5-level] questionnaire). RESULTS: Patients who underwent cholecystectomy as a first step had a significantly shorter length of hospital stay (median, 5 days [interquartile range {IQR}, 1-8] vs median, 8 days [IQR, 6-12]; P < .001), with fewer common duct investigations (25 vs 71; P < .001), no significant difference in morbidity or quality of life. CONCLUSIONS AND RELEVANCE: Among patients at intermediate risk of a common duct stone, initial cholecystectomy compared with sequential common duct endoscopy assessment and subsequent surgery resulted in a shorter length of stay without increased morbidity. If these findings are confirmed, initial cholecystectomy with intraoperative cholangiogram may be a preferred approach. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01492790.

Validation of a dropout assessment model of candidates with/without hepatocellular carcinoma on a common liver transplant waiting list.

The model of end-stage liver disease (MELD) score is often used for liver graft allocation, and patients with hepatocellular carcinoma (HCC) receive exception points (22 in the US). A better model is desirable for patients with HCC as they tend to have a privileged access to transplantation, without taking HCC characteristics into account. A new simpler model designed from a training set of US patients (n = 49 026) was tested on two validation sets (US and UK patient cohorts with, respectively, n = 20 475 and n = 1781). The risk of dropout was between 3.2 and 7.8% at 3 months in patients with HCC, and was captured into a score, including HCC size, HCC number, AFP, and MELD (-37.8 +1.9*MELD+5.9 if HCC Nb ≥ 2 + 5.9 if AFP > 400 + 21.2 if HCC size > 1 cm). This new model could be validated on external US and UK liver candidate cohorts. It provides a dynamic and more accurate assessment of dropout than the use of exception MELD (C-indices of 66.2-73.7% vs. 52.7-56.6%). In addition, the model shows a similar distribution as MELD for patients with non-HCC, and both scores could be used in parallel for the management of waiting-list patients with and without HCC.

Accurate computed tomography-based portal pressure assessment in patients with hepatocellular carcinoma.

BACKGROUND & AIMS: Liver resection is generally restricted to patients without clinically significant portal hypertension (Hepatic Venous Pressure Gradient - HVPG - ⩽10mmHg) and several teams perform transjugular HVPG measurements as part of the pre-operative work-up. The present study investigates whether a non-invasive Computed Tomography (CT)-based assessment could be as accurate as the invasive transjugular measurement. METHODS: A cohort of patients with hepatocellular carcinoma (HCC) treated by resection (n=36) or transplantation (n=39) was selected (mean age: 61±9.2years, male/female ratio: 4/1). Pre-operative CTs were read by two independent investigators, and potential CT-based HVPG predictors were compared to the transjugular HVPG measurements. A validation was conducted on another cohort of 70 non-surgical patients. RESULTS: The invasive HVPG values were significantly correlated to liver/spleen volume ratio, spleen volume, platelet count, and peri-hepatic ascites (p<0.001), which all showed high inter-observer agreements (intra-class correlation coefficients ⩾0.927, Kappa ⩾0.945). The presence of a HVPG >10mmHg was best predicted by the liver/spleen volume ratio (AUC: 0.883 [0.805-0.960]) and the peri-hepatic ascites (p<0.001). These two variables were combined into an accurate model for predicting HVPG >10mmHg (AUC: 0.911 [0.847-0.975]), with sensitivity, specificity, and positive and negative predictive values of 92%, 79%, 91%, and 81%. The model was also accurate in the validation cohort with an AUC of 0.820 [0.719-0.921]. The computed formula was: CONCLUSIONS: The proposed CT-based model showed a high accuracy in the prediction of HVPG and, if further confirmed by prospective validation, could replace the invasive transjugular assessment in patients not requiring a biopsy of the non-tumoral liver.

Assessment of sexual function and conjugal satisfaction prior to and after liver transplantation.

BACKGROUND: The aims of this study were to assess sexual function and conjugal satisfaction in patients prior to and after liver transplantation, and in comparison to healthy individuals. MATERIAL AND METHODS: A cross-sectional cohort questionnaire assessment was performed in adult liver recipients, including the International Index of Erectile Function (IIEF) for men or the Female Sexual Function Index (FSFI) for women. Conjugal satisfaction was assessed with the Locke-Wallace Marital Adjustment Test. Waitlist candidates and age-matched healthy individuals were used as controls. RESULTS: Questionnaires of 136 patients were assessed (45 women/91 men, mean age: 57 ± 11 years). Overall, sexual function improved after transplantation (male: p=0.065 and female: p=0.072), but remained lower than in aged-matched healthy individuals. The post-transplant level of conjugal satisfaction was stable and similar to healthy controls in men, but improved significantly in women (p=0.008), with higher levels than in healthy subjects (p=0.05). CONCLUSIONS: The present study shows that sexual function improves after transplantation, yet not to the level of healthy controls. It also demonstrates, for the first time, that post-transplant conjugal satisfaction is at least similar to the one of healthy controls.

A model for dropout assessment of candidates with or without hepatocellular carcinoma on a common liver transplant waiting list.

UNLABELLED: In many countries, the allocation of liver grafts is based on the Model of End-stage Liver Disease (MELD) score and the use of exception points for patients with hepatocellular carcinoma (HCC). With this strategy, HCC patients have easier access to transplantation than non-HCC ones. In addition, this system does not allow for a dynamic assessment, which would be required to picture the current use of local tumor treatment. This study was based on the Scientific Registry of Transplant Recipients and included 5,498 adult candidates of a liver transplantation for HCC and 43,528 for non-HCC diagnoses. A proportional hazard competitive risk model was used. The risk of dropout of HCC patients was independently predicted by MELD score, HCC size, HCC number, and alpha-fetoprotein. When combined in a model with age and diagnosis, these factors allowed for the extrapolation of the risk of dropout. Because this model and MELD did not share compatible scales, a correlation between both models was computed according to the predicted risk of dropout, and drop-out equivalent MELD (deMELD) points were calculated. CONCLUSION: The proposed model, with the allocation of deMELD, has the potential to allow for a dynamic and combined comparison of opportunities to receive a graft for HCC and non-HCC patients on a common waiting list.

Reducing cost of surgery by avoiding complications: the model of robotic Roux-en-Y gastric bypass.

BACKGROUND: Robotic surgery is a complex technology offering technical advantages over conventional methods. Still, clinical outcomes and financial issues have been subjects of debate. Several studies have demonstrated higher costs for robotic surgery when compared to laparoscopy or open surgery. However, other studies showed fewer costly anastomotic complications after robotic Roux-en-Y gastric bypass (RYGBP) when compared to laparoscopy. METHODS: We collected data for our gastric bypass patients who underwent open, laparoscopic, or robotic surgery from June 1997 to July 2010. Demographic data, BMI, complications, mortality, intensive care unit stay, hospitalization, and operating room (OR) costs were analyzed and a cost projection completed. Sensitivity analyses were performed for varied leak rates during laparoscopy, number of robotic cases per month, number of additional staplers during robotic surgery, and varied OR times for robotic cases. RESULTS: Nine-hundred ninety patients underwent gastric bypass surgery at the University Hospital Geneva from June 1997 to July 2010. There were 524 open, 323 laparoscopic, and 143 robotic cases. Significantly fewer anastomotic complications occurred after open and robotic RYGBP when compared to laparoscopy. OR material costs were slightly less for robotic surgery (USD 5,427) than for laparoscopy (USD 5,494), but more than for the open procedure (USD 2,251). Overall, robotic gastric bypass (USD 19,363) was cheaper when compared to laparoscopy (USD 21,697) and open surgery (USD 23,000). CONCLUSIONS: Robotic RYGBP can be cost effective due to balancing greater robotic overhead costs with the savings associated with avoiding stapler use and costly anastomotic complications.

Value of contrast-enhanced 18F-fluorodeoxyglucose positron emission tomography/computed tomography in detection and presurgical assessment of pancreatic cancer: a prospective study.

BACKGROUND AND AIM: Positron Emission Tomography (PET) using (18)F-fluorodeoxyglucose (FDG) associated with computed tomography (CT) is increasingly used for the detection and the staging of pancreatic cancer, but data regarding its clinical added value in pre-surgical planning is still lacking. The aim of this study is to investigate the performance of FDG PET associated with contrast-enhanced CT in detection of pancreatic cancer. METHODS: We prospectively evaluated FDG PET/CT studies obtained in patients with suspicion of operable pancreatic cancer between May 2006 and January 2008. Staging was conducted according to a standardized protocol, and findings were confirmed in all patients by surgical resection or biopsy examination. RESULTS: Forty-five patients with a median age of 69 (range 22-82) were included in this study. Thirty-six had malignant tumors and nine had benign lesions (20%). The sensitivity of enhanced versus unenhanced PET/CT in the detection of pancreatic cancer was 96% versus 72% (P=0.076), the specificity 66.6% versus 33.3% (P=0.52), the positive predictive value 92.3% versus 80% (P=0.3), the negative predictive value 80% versus 25% (P=0.2), and the accuracy 90.3% versus 64% (P=0.085). CONCLUSIONS: Our preliminary data obtained in a limited number of patients shows that contrast-enhanced FDG PET/CT offers good sensitivity in the detection and assessment of pancreatic cancer, but at the price of a relatively low specificity. Enhanced PET/CT seems to be superior to unenhanced PET/CT. Further larger prospective studies are needed to establish its value for pre-surgical diagnosis and staging in pancreatic cancer.

Assessment of human islet labeling with clinical grade iron nanoparticles prior to transplantation for graft monitoring by MRI.

Ex vivo labeling of islets with superparamagnetic iron oxide (SPIO) nanoparticles allows posttransplant MRI imaging of the graft. In the present study, we compare two clinical grade SPIOs (ferucarbotran and ferumoxide) in terms of toxicity, islet cellular uptake, and MRI imaging. Human islets (80-90% purity) were incubated for 24 h with various concentrations of SPIOs (14-280 µg/ml of iron). Static incubations were performed, comparing insulin response to basal (2.8 mM) or high glucose stimulation (16.7 mM), with or without cAMP stimulation. Insulin and Perl's (assessment of iron content) staining were performed. Electronic microscopy analysis was performed. Labeled islets were used for in vitro or in vivo imaging in MRI 1.5T. Liver section after organ removal was performed in the same plane as MRI imaging to get a correlation between histology and radiology. Postlabeling islet viability (80 ± 10%) and function (in vitro static incubation and in vivo engraftment of human islets in nude mice) were similar in both groups. Iron uptake assessed by electron microscopy showed iron inclusions within the islets with ferucarbotran, but not with ferumoxide. MRI imaging (1.5T) of phantoms and of human islets transplanted in rats, demonstrated a strong signal with ferucarbotran, but only a weak signal with ferumoxide. Signal persisted for >8 weeks in the absence of rejection. An excellent correlation was observed between radiologic images and histology. The hepatic clearance of intraportally injected ferucarbotran was faster than that of ferumoxide, generating less background. A rapid signal decrease was observed in rejecting xenogeneic islets. According to the present data, ferucarbotran is the most appropriate of available clinical grade SPIOs for human islet imaging.

Logistics and transplant coordination activity in the GRAGIL Swiss-French multicenter network of islet transplantation.

BACKGROUND: Since the Edmonton trial in 2000, increasing numbers of transplant centers have been implementing islet transplantation programs. Some institutions have elected to associate in multicenter networks, such as the Swiss-French GRAGIL (Groupe Rhin-Rhône-Alpes-Genève pour la Transplantation d'Ilots de Langerhans) consortium. METHODS: All pancreata offers to the University of Geneva Cell Isolation and Transplantation Center from within the network in 2002 and 2003 were reviewed. Islet preparations were attributed to the most suitable recipient on a centrally managed waiting list. All shipments were performed by ambulance in less than 5 hr. RESULTS: Over the period of study, 260 pancreata were offered, from a total of 1,304 cadaveric donors in the four allocation regions (20%). Fifty-two patients were on the waiting list at any time during this 2-year period. The percentage of organs offered varied in the range of 0.5% to 42%, depending on region of origin, with a correlation with number of patients on the waiting list in each region. Of these, 104 (40%) were accepted for processing. Ninety-two pancreata were actually processed, resulting in 42 islet preparations being transplanted. The number of international equivalents of transplanted preparations was 378,500+/-16,000 versus 165,400+/-15,400 (P<0.0001) for nontransplanted preparations. Total cold ischemia time was 6+/-0.3 hr for transplanted preparations versus 6.7+/-0.4 hr for nontransplanted preparations (not significant). CONCLUSIONS.: A high rate of pancreas offers, successful isolation, and islet transplantation can be achieved in multicenter networks such as GRAGIL. Such an approach can expand both the donor pool and the recipient population.

Assessment of quality of life in patients with rectal cancer treated by preoperative radiotherapy: a longitudinal prospective study.

PURPOSE: To assess prospectively the quality of life (QOL) of patients treated by preoperative radiotherapy (RT) and surgery for locally advanced rectal cancer. METHODS AND MATERIALS: We studied 53 patients treated with bi-fractionated RT (50 Gy in 40 fractions within 4 weeks) followed at a median interval of 45 days by abdominoperineal resection in 11 patients and low anterior resection in 42 patients. Their QOL was assessed using two self-rating questionnaires developed by the European Organization for Research and Treatment of Cancer (EORTC): one was cancer specific (EORTC QLQ-C30) and one was site specific (EORTC QLQ-C38). The questionnaires were completed before RT and 12-16 months after RT, at which time 17 patients had undergone colostomy. We hypothesized that at least some scores of the various scales would vary between the two analyses. RESULTS: Compared with the pre-RT scores, at 1 year, patients reported statistically significant improvement in their emotional state (median 75 vs. 100, p <0.0001), perspective of the future (67 vs. 100, p = 0.0004), and their global QOL (75 vs. 83, p = 0.0008), as well as a decrease in GI symptoms (13 vs. 0, p = 0.002). However, the sexual dysfunction score increased significantly, particularly in men (17 vs. 83, p = 0.0045), and a trend toward a lower body image score was observed (100 vs. 89, p = 0.068). At 1 year, patients with colostomies reported similar or significantly improved symptom scores for fatigue, pain, GI problems, and sleep disturbance, but no such improvements were observed in patients without stomas. CONCLUSION: One year after combined treatment for locally advanced rectal cancer, patients exhibited statistically significant improvement in some important QOL outcomes, including global QOL, despite a decrease in sexual function and body image. Any additional improvement in QOL outcome may require refinements in the RT and surgical techniques to reduce late sequelae, particularly sexual dysfunction. Our results suggest that QOL considerations do not justify sphincter-conserving approaches if locoregional tumor control would be compromised.

Assessment of a novel two-component enzyme preparation for human islet isolation and transplantation.

BACKGROUND: Biologic characteristics of enzyme products used for islet isolation are critical for the success of islet transplantation. In particular, lot-to-lot variability significantly affects the yields of the isolation procedure. In this study, we have evaluated a new enzyme preparation in which highly purified collagenase can be blended with separately supplied neutral protease in a predetermined ratio. METHODS: We compared the results of human-islet isolations performed either with Collagenase NB1 supplemented with Neutral Protease NB (group I, n=9) or with Liberase (group II, n=9). RESULTS: Endotoxin contents of the enzyme preparations were lower in group I. Total islet yields were similar in both groups, but islet equivalents per gram of pancreas was higher in group I (4,020+/-1,240 vs. 2,360+/-1,350; P<0.05). Islet morphology was improved in group I with significantly higher proportion of free and intact islets (71+/-9% vs. 52+/-14%; P<0.01). In vitro function was improved and apoptosis rate was lower in group I. CONCLUSIONS: This new enzyme blend was as efficient as Liberase in terms of islet yields and showed improvements in islet morphology, viability, and in vitro function. The possibility to control lot-to-lot variability and the low endotoxin contents make Collagenase NB1 a promising product for human-islet isolation.