Is Routine Post-operative Biological Laboratory Assessment Necessary After Sleeve Gastrectomy?

BACKGROUND: Incidence of post-operative complications after sleeve gastrectomy (SG) is low. However, the early identification of these complications remains crucial. Here, we report the impact of routine laboratory monitoring for the early diagnosis of complications after SG. MATERIAL AND METHODS: From January 2018 to December 2019, all consecutive patients who underwent primary SG (n = 457) were included. This was a comparative study of patients undergoing primary SG. Patients were divided into two groups: one group with routine laboratory monitoring performed at postoperative day (POD) 1 and 3 (LAB group) and another group without routine laboratory monitoring (control group). The study's primary endpoint was the overall impact of routine laboratory monitoring. The secondary endpoints were evaluation of patients with complications. RESULTS: The population in the two groups were similar in term of demographic and intra-operative data. There was a statistical difference between the two groups in term of length of stay (5.7 days in the LAB group and 3.5 days in the control group (p < 0.001)). There were 19 complications (6.0%) in the LAB group and 5 complications in the control group (3.5%) (p = 0.25). A cut-off C-reactive protein level of 46.3 mg/l was found to be significant (p = 0.006). In the LAB group, 9 patients (2.9%) required readmission vs. three patients (2.0%) in the control group (p = 0.62). CONCLUSION: The interest of routine laboratory monitoring after SG seems limited. Routine laboratory monitoring alone is not associated with earlier diagnosis of complications. This routine monitoring is associated with an increase of stay in hospital.

Impact of Robotic Assistance on Complications in Bariatric Surgery at Expert Laparoscopic Surgery Centers: A Retrospective Comparative Study With Propensity Score.

OBJECTIVE: To investigate the way robotic assistance affected rate of complications in bariatric surgery at expert robotic and laparoscopic surgery facilities. BACKGROUND: While the benefits of robotic assistance were established at the beginning of surgical training, there is limited data on the robot's influence on experienced bariatric laparoscopic surgeons. METHODS: We conducted a retrospective study using the BRO clinical database (2008-2022) collecting data of patients operated on in expert centers. We compared the serious complication rate (defined as a Clavien score≥3) in patients undergoing metabolic bariatric surgery with or without robotic assistance. We used a directed acyclic graph to identify the variables adjustment set used in a multivariable linear regression, and a propensity score matching to calculate the average treatment effect (ATE) of robotic assistance. RESULTS: The study included 35,043 patients [24,428 sleeve gastrectomy (SG); 10,452 Roux-en-Y gastric bypass (RYGB); 163 single anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S)], with 938 operated on with robotic assistance (801 SG; 134 RYGB; 3 SADI-S), among 142 centers. Overall, we found no benefit of robotic assistance regarding the risk of complications (average treatment effect=-0.05, P =0.794), with no difference in the RYGB+SADI group ( P =0.322) but a negative trend in the SG group (more complications, P =0.060). Length of hospital stay was decreased in the robot group (3.7±11.1 vs 4.0±9.0 days, P <0.001). CONCLUSIONS: Robotic assistance reduced the length of stay but did not statistically significantly reduce postoperative complications (Clavien score≥3) following either GBP or SG. A tendency toward an elevated risk of complications following SG requires more supporting studies.

Analysis of the Efficacy and the Long-term Metabolic and Nutritional Status of Sleeve Gastrectomy with Transit Bipartition Compared to Roux-en-Y Gastric Bypass in Obese Rats.

PURPOSE: Sleeve gastrectomy with transit bipartition (SG-TB) could be an attractive alternative to Roux-en-Y gastric bypass (RYGB) on weight loss and improvement of comorbidities in patients with obesity. However, there is little long-term data. Translational research on a rat model could allow long-term projection to assess efficacy and safety of SG-TB. The aim of this research was to evaluate the long-term efficacy and safety of SG-TB compared to RYGB and SHAM in rat model. MATERIALS AND METHODS: Ninety-four male obese Wistar rats were distributed into 3 groups: SG-TB (n = 34), RYGB (n = 32), and SHAM (control group, n = 28). The percentage of total weight loss (%TWL), coprocalorimetry, glucose and insulin tolerance test, insulin, GLP-1, PYY, and GIP before and after surgery were assessed. The animals were followed over 6 months (equivalent to 16 years in humans). RESULTS: At 6 months, %TWL was significantly greater(p = 0.025) in the SG-TB group compared to the RYGB group. There was no difference between the groups (p = 0.86) in malabsorption 15 and 120 days postoperatively. Glucose tolerance was significantly improved (p = 0.03) in the SG-TB and RYGB groups compared to the preoperative state. Insulin secretion, at 3 months, was significantly more important in the SG-TB group (p = 0.0003), compared to the RYGB and SHAM groups. GLP-1 secretion was significantly increased in the SG-TB and RYGB groups compared to the preoperative state (p = 0.001) but similar between SG-TB and RYGB animals (p = 0.72). CONCLUSION: In a rat model, at long term compared to RYGB, SG-TB provides greater and better-maintained weight loss and an increased insulin secretion without impairing nutritional status.

Endoscopy management of sleeve gastrectomy stenosis: what we learned from 202 consecutive patients.

BACKGROUND: Gastric sleeve stenosis (GSS) is described in 1%-4% of patients. OBJECTIVE: To evaluate the role of endoscopy in the management of stenosis after laparoscopic sleeve gastrectomy using a standardized approach according to the characteristic of stenosis. SETTING: Retrospective, observational, single-center study on patients referred from several bariatric surgery departments to an endoscopic referral center. METHODS: We enrolled 202 patients. All patients underwent endoscopy in a fluoroscopy setting, and a systematic classification of the type, site, and length of the GSS was performed. According to the characteristics of the stenosis, patients underwent pneumatic dilatation or placement of a self-expandable metal stent or a lumen-apposed metal stent. Failure of endoscopic treatment was considered an indication for redo surgery, whereas patients with partial or complete response were followed up for 2 years. In the event of a recurrence, a different endoscopic approach was used. RESULTS: We found inflammatory strictures in 4.5% of patients, pure narrowing in 11%, and functional stenosis in 84.5%. Stenosis was in the upper tract of the stomach in 53 patients, whereas medium and distal stenosis was detected in 138 and 11 patients, respectively, and short stenosis in 194 patients. A total of 126 patients underwent pneumatic dilatation, 8 self-expandable metal stent placement, 64 lumen-apposed metal stent positioning, and 36 combined therapy. The overall rate of endoscopy success was 69%. CONCLUSION: GSS should be considered to be a chronic disease, and the endoscopic approach seems to be the most successful treatment, with a prolonged positive outcome of 69%. Characteristics of the stenosis should guide the most suitable endoscopic approach.

Conversion of One Anastomosis Gastric Bypass to Roux-en-Y Gastric Bypass: Results of a Retrospective Multicenter Study.

BACKGROUND: One anastomosis gastric bypass (OAGB) may expose the patient to certain specific complications. Here, we report the results of conversion of OAGB to Roux-en-Y gastric bypass (RYGB) in terms of outcomes and weight loss. METHODS: Between January 2009 and January 2019, all patients undergoing conversion of OAGB to RYGB because of complications due to OAGB (n = 23) were included. The primary efficacy endpoint was the effectiveness of converting OAGB to RYGB. The secondary endpoints were overall mortality and morbidity during the first 3 postoperative months, specific morbidity, reoperation, length of hospitalization, weight loss, and progression of comorbidities related to obesity at 2-year follow-up. RESULTS: Indications for conversion were bile reflux (n = 14; 60.9%), severe malnutrition (n = 3; 13%), gastro-gastric fistula (n = 4; 17.4%), and anastomotic leak (n = 2; 8.7%). The median time interval between OAGB and conversion to RYGB was 34 months (0-158). At the time of RYGB, median body mass index (BMI) was 28.0 kg/m2 (18.2-50.7), representing a median BMI change of 14.0 (- 1.7-43.5). Fifteen surgeries (65.1%) were completed laparoscopically. Five complications (21.7%) were recorded, including 2 major ones (8.7%). Reoperation rate was 4.3% (n = 1). At 24 months of follow-up (n = 18; 78.3%), median BMI was 28.7 kg/m2 (19.4-35.4), representing a median BMI change of 19.5 (12.2-43.1). No patient complained of bile reflux or persistent malnutrition. CONCLUSION: RYGB performed as revisional surgery for complications after OAGB is an effective procedure with no major weight regain at 2 years of follow-up.

Bariatric Surgery in Patients With Inflammatory Bowel Disease: A Case-Control Study from the GETAID.

BACKGROUND: The prevalence of obesity and the number of bariatric surgeries in both the general population and in patients with inflammatory bowel disease (IBD) have increased significantly in recent years. Due to small sample sizes and the lack of adequate controls, no definite conclusions can be drawn from the available studies on the safety and efficacy of bariatric surgery (BS) in patients with IBD. Our aim was to assess safety, weight loss, and deficiencies in patients with IBD and obesity who underwent BS and compare findings to a control group. METHODS: Patients with IBD and a history of BS were retrospectively recruited to centers belonging to the Groupe d'Etude Thérapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Patients were matched 1:2 for age, sex, body mass index (BMI), hospital of surgery, and type of BS with non-IBD patients who underwent BS. Complications, rehospitalizations, weight, and deficiencies after BS were collected in cases and controls. RESULTS: We included 88 procedures in 85 patients (64 Crohn's disease, 20 ulcerative colitis, 1 unclassified IBD) with a mean BMI of 41.6 ± 5.9 kg/m2. Bariatric surgery included Roux-en-Y gastric bypass (n = 3), sleeve gastrectomy (n = 73), and gastric banding (n = 12). Eight (9%) complications were reported, including 4 (5%) requiring surgery. At a mean follow-up of 34 months, mean weight was 88.6 ± 22.4 kg. No difference was observed between cases and controls for postoperative complications (P = .31), proportion of weight loss (P = .27), or postoperative deficiencies (P = .99). CONCLUSIONS: Bariatric surgery is a safe and effective procedure in patients with IBD and obesity; outcomes in this patient group were similar to those observed in a control population.

Prospective comparison of transient elastography, MRI and serum scores for grading steatosis and detecting non-alcoholic steatohepatitis in bariatric surgery candidates.

BACKGROUND & AIMS: Tools for the non-invasive diagnosis of non-alcoholic steatohepatitis (NASH) in morbidly obese patients with suspected non-alcoholic fatty liver disease (NAFLD) are an unmet clinical need. We prospectively compared the performance of transient elastography, MRI, and 3 serum scores for the diagnosis of NAFLD, grading of steatosis and detection of NASH in bariatric surgery candidates. METHODS: Of 186 patients screened, 152 underwent liver biopsy, which was used as a reference for NAFLD (steatosis [S]>5%), steatosis grading and NASH diagnosis. Biopsies were read by a single expert pathologist. MRI-based proton density fat fraction (MRI-PDFF) was measured in an open-bore, vertical field 1.0T scanner and controlled attenuation parameter (CAP) was measured by transient elastography, using the XL probe. Serum scores (SteatoTest, hepatic steatosis index and fatty liver index) were also calculated. RESULTS: The applicability of MRI was better than that of FibroScan (98% vs. 79%; p <0.0001). CAP had AUROCs of 0.83, 0.79, 0.73 and 0.69 for S>5%, S>33%, S>66% and NASH, respectively. Transient elastography had an AUROC of 0.80 for significant fibrosis (F0-F1 vs. F2-F3). MRI-PDFF had AUROCs of 0.97, 0.95, 0.92 and 0.84 for S>5%, S>33%, S>66% and NASH, respectively. When compared head-to-head in the 97 patients with all valid tests available, MRI-PDFF outperformed CAP for grading steatosis (S>33%, AUROC 0.97 vs. 0.78; p <0.0003 and S>66%, AUROC 0.93 vs. 0.75; p = 0.0015) and diagnosing NASH (AUROC 0.82 vs. 0.68; p = 0.0056). When compared in "intention to diagnose" analysis, MRI-PDFF outperformed CAP, hepatic steatosis index and fatty liver index for grading steatosis (S>5%, S>33% and S>66%). CONCLUSION: MRI-PDFF outperforms CAP for diagnosing NAFLD, grading steatosis and excluding NASH in morbidly obese patients undergoing bariatric surgery. LAY SUMMARY: Non-invasive tests for detecting fatty liver and steatohepatitis, the active form of the disease, have not been well studied in obese patients who are candidates for bariatric surgery. The most popular tests for this purpose are Fibroscan, which can be used to measure the controlled attenuation parameter (CAP), and magnetic resonance imaging, which can be used to measure the proton density fat fraction (MRI-PDFF). We found that, when taking liver biopsy as a reference, MRI-PDFF performed better than CAP for detecting and grading fatty liver as well as excluding steatohepatitis in morbidly obese patients undergoing bariatric surgery.

Hepcidin and Iron Deficiency in Women One Year after Sleeve Gastrectomy: A Prospective Cohort Study.

Iron deficiency with or without anemia, needing continuous iron supplementation, is very common in obese patients, particularly those requiring bariatric surgery. The aim of this study was to address the impact of weight loss on the rescue of iron balance in patients who underwent sleeve gastrectomy (SG), a procedure that preserves the duodenum, the main site of iron absorption. The cohort included 88 obese women; sampling of blood and duodenal biopsies of 35 patients were performed before and one year after SG. An analysis of the 35 patients consisted in evaluating iron homeostasis including hepcidin, markers of erythroid iron deficiency (soluble transferrin receptor (sTfR) and erythrocyte protoporphyrin (PPIX)), expression of duodenal iron transporters (DMT1 and ferroportin) and inflammatory markers. After surgery, sTfR and PPIX were decreased. Serum hepcidin levels were increased despite the significant reduction in inflammation. DMT1 abundance was negatively correlated with higher level of serum hepcidin. Ferroportin abundance was not modified. This study shed a new light in effective iron recovery pathways after SG involving suppression of inflammation, improvement of iron absorption, iron supply and efficiency of erythropoiesis, and finally beneficial control of iron homeostasis by hepcidin. Thus, recommendations for iron supplementation of patients after SG should take into account these new parameters of iron status assessment.

Endoscopic Management of Bariatric Surgery Complications According to a Standardized Algorithm.

BACKGROUND AND AIMS: Endoscopy is effective in management of bariatric surgery (BS) adverse events (AEs) but a comprehensive evaluation of long-term results is lacking. Our aim is to assess the effectiveness of a standardized algorithm for the treatment of BS-AE. PATIENTS AND METHODS: We retrospectively analyzed 1020 consecutive patients treated in our center from 2012 to 2020, collecting data on demographics, type of BS, complications, and endoscopic treatment. Clinical success (CS) was evaluated considering referral delay, healing time, surgery, and complications type. Logistic regression was performed to identify variables of CS. RESULTS: In the study period, we treated 339 fistulae (33.2%), 324 leaks (31.8%), 198 post-sleeve gastrectomy twist/stenosis (19.4%), 95 post-RYGB stenosis (9.3 %), 37 collections (3.6%), 15 LAGB migrations (1.5%), 7 weight regains (0.7%), and 2 hemorrhages (0.2%). Main endoscopic treatments were as follows: pigtail-stent positioning under endoscopic view for both leaks (CS 86.1%) and fistulas (CS 77.2%), or under EUS-guidance for collections (CS 88.2%); dilations and/or stent positioning for sleeve twist/stenosis (CS 80.6%) and bypass stenosis (CS 81.5%). After a median (IQR) follow-up of 18.5 months (4.29-38.68), complications rate was 1.9%. We found a 1% increased risk of redo-surgery every 10 days of delay to the first endoscopic treatment. Endoscopically treated patients had a more frequent regular diet compared to re-operated patients. CONCLUSIONS: Endoscopic treatment of BS-AEs following a standardized algorithm is safe and effective. Early endoscopic treatment is associated with an increased CS rate.

Endoscopic internal drainage for the management of leak, fistula, and collection after sleeve gastrectomy: our experience in 617 consecutive patients.

BACKGROUND: Endoscopy plays a pivotal role in the management of adverse events (AE) following bariatric surgery. Leaks, fistulae, and post-operative collection after sleeve gastrectomy (SG) may occur in up to 10% of cases. OBJECTIVES: To evaluate the efficacy and safety of endoscopic internal drainage (EID) for the management of leak, fistula, and collection following SG. SETTING: Retrospective, observational, single center study on patients referred from several bariatric surgery departments to an endoscopic referral center. METHODS: EID was used as first-line treatment for the management of leaks, fistulae, and collections. Leaks and fistulae were treated with double pigtail stent (DPS) deployment in order to guarantee internal drainage and second intention cavity obliteration. Collections were treated with endoscropic ultrasound (EUS)-guided deployment of DPS or lumen apposing metal stents. RESULTS: A total of 617 patients (83.3% female; mean age, 43.1 yr) were enrolled in the study for leak (n = 300, 48.6%), fistula (n = 285, 46.2%), and collection (n = 32, 5.2%). Median follow-up was 19.5 months. Overall clinical success was 84.7% whereas 15.3% of cases required revisional surgery after EID failure. Clinical success according to type of AE was 89.5%, 78.5%, and 90% for leak, fistula, and collection, respectively. A total of 10 of 547 (1.8%) presented a recurrence during follow-up. A total of 28 (4.5%) AE related to the endoscopic treatment occurred. At univariate logistic regression predictors of failure were: fistula (OR 2.012), combined endoscopic approach (OR 2.319), need for emergency surgery (OR 1.755), and previous endoscopic treatment (OR 4.818). CONCLUSION: Early EID for the management of leak, fistula, and post-operative collection after SG seems a safe and effective first-line approach with good long-term results.

Five-Year Survival Outcomes of Hybrid Minimally Invasive Esophagectomy in Esophageal Cancer: Results of the MIRO Randomized Clinical Trial.

Importance: Available data comparing the long-term results of hybrid minimally invasive esophagectomy (HMIE) with that of open esophagectomy are conflicting, with similar or even better results reported for the minimally invasive esophagectomy group. Objective: To evaluate the long-term, 5-year outcomes of HMIE vs open esophagectomy, including overall survival (OS), disease-free survival (DFS), and pattern of disease recurrence, and the potential risk factors associated with these outcomes. Design, Setting, and Participants: This randomized clinical trial is a post hoc follow-up study that analyzes the results of the open-label Multicentre Randomized Controlled Phase III Trial, which enrolled patients from 13 different centers in France and was conducted from October 26, 2009, to April 4, 2012. Eligible patients were 18 to 75 years of age and were diagnosed with resectable cancer of the middle or lower third of the esophagus. After exclusions, patients were randomized to either the HMIE group or the open esophagectomy group. Data analysis was performed on an intention-to-treat basis from November 19, 2019, to December 4, 2020. Interventions: Hybrid minimally invasive esophagectomy (laparoscopic gastric mobilization with open right thoracotomy) was compared with open esophagectomy. Main Outcomes and Measures: The primary end points of this follow-up study were 5-year OS and DFS. The secondary end points were the site of disease recurrence and potential risk factors associated with DFS and OS. Results: A total of 207 patients were randomized, of whom 175 were men (85%), and the median (range) age was 61 (23-78) years. The median follow-up duration was 58.2 (95% CI, 56.5-63.8) months. The 5-year OS was 59% (95% CI, 48%-68%) in the HMIE group and 47% (95% CI, 37%-57%) in the open esophagectomy group (hazard ratio [HR], 0.71; 95% CI, 0.48-1.06). The 5-year DFS was 52% (95% CI, 42%-61%) in the HMIE group vs 44% (95% CI, 34%-53%) in the open esophagectomy group (HR, 0.81; 95% CI, 0.55-1.17). No statistically significant difference in recurrence rate or location was found between groups. In a multivariable analysis, major intraoperative and postoperative complications (HR, 2.21; 95% CI, 1.41-3.45; P < .001) and major pulmonary complications (HR, 1.94; 95% CI, 1.21-3.10; P = .005) were identified as risk factors associated with decreased OS. Similarly, multivariable analysis of DFS identified overall intraoperative and postoperative complications (HR, 1.93; 95% CI, 1.28-2.90; P = .002) and major pulmonary complications (HR, 1.85; 95% CI, 1.19-2.86; P = .006) as risk factors. Conclusions and Relevance: This study found no difference in long-term survival between the HMIE and open esophagectomy groups. Major postoperative overall complications and pulmonary complications appeared to be independent risk factors in decreased OS and DFS, providing additional evidence that HMIE may be associated with improved oncological results compared with open esophagectomy primarily because of a reduction in postoperative complications. Trial Registration: ClinicalTrials.gov Identifier: NCT00937456.

Bariatric surgery induces a new gastric mucosa phenotype with increased functional glucagon-like peptide-1 expressing cells.

Glucagon-Like Peptide-1 (GLP-1) undergoes rapid inactivation by dipeptidyl peptidase-4 (DPP4) suggesting that target receptors may be activated by locally produced GLP-1. Here we describe GLP-1 positive cells in the rat and human stomach and found these cells co-expressing ghrelin or somatostatin and able to secrete active GLP-1 in the rats. In lean rats, a gastric load of glucose induces a rapid and parallel rise in GLP-1 levels in both the gastric and the portal veins. This rise in portal GLP-1 levels was abrogated in HFD obese rats but restored after vertical sleeve gastrectomy (VSG) surgery. Finally, obese rats and individuals operated on Roux-en-Y gastric bypass and SG display a new gastric mucosa phenotype with hyperplasia of the mucus neck cells concomitant with increased density of GLP-1 positive cells. This report brings to light the contribution of gastric GLP-1 expressing cells that undergo plasticity changes after bariatric surgeries, to circulating GLP-1 levels.

Efficacy and Safety of the Duodeno-Jejunal Bypass Liner in Patients With Metabolic Syndrome: A Multicenter Randomized Controlled Trial (ENDOMETAB).

OBJECTIVE: The aim of this study was to compare the efficacy and safety of 12-month implantation of a duodeno-jejunal bypass liner (DJBL) with conventional medical care in patients with metabolic syndrome (MS). SUMMARY BACKGROUND DATA: DJBL is an endoscopic device for treating obesity and related disorders. The persistence of favorable results after 6 months has not been tested in a controlled study. METHODS: We conducted a multicenter randomized controlled trial, stratified by center and diabetes status. The primary endpoint was the remission of MS at 12 months. The secondary endpoints included body mass index (BMI), glucose control, blood pressure, and lipids, assessed at 12 months after implantation, and again, at 12 months after the removal of the DJBL. Up to 174 subjects were planned to be randomized into either the DJBL or the control arm at a 2:1 ratio, respectively. Study enrollment was discontinued by the Scientific Monitoring Committee due to the early termination of the ENDO trial (NCT01728116) by the US Food and Drug Administration. The study was terminated after withdrawal of the device's European Conformity marking by the European Medicines Agency, and an interim analysis was performed. RESULTS: A total of 82 patients were enrolled (67.5% female, 48.8% with diabetes). At 12 months after randomization, the primary endpoint was met in 6 (12%) DJBL patients and 3 (10%) controls (P = 0.72). Patients in the DJBL group experienced greater BMI loss [mean adjusted difference (95% confidence interval, CI) -3.1 kg/m (-4.4 to -1.9) kg/m, P < 0.001] and HbA1c change [mean adjusted difference -0.5% (95% CI -0.9 to -0.2); P < 0.001] than those in the control group. No difference remained statistically significant at 12 months after the removal of the DJBL. In the DJBL group, 39% of patients experienced at least one device-related serious adverse event, which was classified as Grade III Dindo-Clavien in 22%, and required premature device explantation in 16%. CONCLUSIONS: The present study showed a transient clinical benefit of DJBL, which was only apparent at 1 year, when the device was still in situ, and was obtained at the risk of serious device-related adverse events in 39% of patients. These results do not support the routine use of DJBL for weight loss and glucose control in patients with MS.

Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open-label, phase III study (NUTRILEAK study).

BACKGROUND: Postoperative upper gastrointestinal fistula (PUGIF) is a devastating complication, leading to high mortality (reaching up to 80%), increased length of hospital stay, reduced health-related quality of life and increased health costs. Nutritional support is a key component of therapy in such cases, which is related to the high prevalence of malnutrition. In the prophylactic setting, enteral nutrition (EN) is associated with a shorter hospital stay, a lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery. There is little evidence available for the curative setting after fistula occurrence. We hypothesize that EN increases the 30-day fistula closure rate in PUGIF, allowing better health-related quality of life without increasing the morbidity or mortality. METHODS/DESIGN: The NUTRILEAK trial is a multicenter, randomized, parallel-group, open-label phase III trial to assess the efficacy of EN (the experimental group) compared with TPN (the control group) in patients with PUGIF. The primary objective of the study is to compare EN versus TPN in the treatment of PUGIF (after esophagogastric resection including bariatric surgery, duodenojejunal resection or pancreatic resection with digestive tract violation) in terms of the 30-day fistula closure rate. Secondary objectives are to evaluate the 6-month postrandomization fistula closure rate, time of first fistula closure (in days), the medical- and surgical treatment-related complication rate at 6 months after randomization, the fistula-related complication rate at 6 months after randomization, the type and severity of early (30 days after randomization) and late fistula-related complications (over 30 days after randomization), 30-day and 6-month postrandomization mortality rate, nutritional status at day 30, day 60, day 90 and day 180 postrandomization, the mean length of hospital stay, the patient's health-related quality of life (by self-assessment questionnaire), oral feeding time and direct costs of treatment. A total of 321 patients will be enrolled. DISCUSSION: The two nutritional supports are already used in daily practice, but most surgeons are reluctant to use the enteral route in case of PUGIF. This study will be the first randomized trial testing the role of EN versus TPN in PUGIF. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03742752. Registered on 14 November 2018.

Long-term consequences of one anastomosis gastric bypass on esogastric mucosa in a preclinical rat model.

Although bariatric surgery is proven to sustain weight loss in morbidly obese patients, long-term adverse effects have yet to be fully characterized. This study compared the long-term consequences of two common forms of bariatric surgery: one-anastomosis gastric bypass (OAGB) and Roux-en-Y Gastric Bypass (RYGB) in a preclinical rat model. We evaluated the influence of biliopancreatic limb (BPL) length, malabsorption, and bile acid (BA) reflux on esogastric mucosa. After 30 weeks of follow-up, Wistar rats operated on RYGB, OAGB with a short BPL (15 cm, OAGB-15), or a long BPL (35 cm, OAGB-35), and unoperated rats exhibit no cases of esogastric cancer, metaplasia, dysplasia, or Barrett's esophagus. Compared to RYGB, OAGB-35 rats presented higher rate of esophagitis, fundic gastritis and perianastomotic foveolar hyperplasia. OAGB-35 rats also revealed the greatest weight loss and malabsorption. On the contrary, BA concentrations were the highest in the residual gastric pouch of OAGB-15 rats. Yet, no association could be established between the esogastric lesions and malabsorption, weight loss, or gastric bile acid concentrations. In conclusion, RYGB results in a better long-term outcome than OAGB, as chronic signs of biliary reflux or reactional gastritis were reported post-OAGB even after reducing the BPL length in a preclinical rat model.

Sleeve gastrectomy as a rescue of failed gastric banding: comparison of 1- and 2-step approaches.

BACKGROUND: Series comparing gastric banding (GB) removal and sleeve gastrectomy (SG) when procedures are performed as a 1- or a 2-step approach are contradictory in their outcomes. No series comparing these approaches with midterm weight loss is available. OBJECTIVES: Compare the outcomes and weight loss of SG performed as 1- and 2-step approaches as a revisional procedure for GB failure. SETTING: University Hospital, France, public practice. METHODS: Between February 2006 and January 2017, all patients undergoing SG with a previous history of implementation of GB (n = 358) were included in this 2-center, retrospective, observational study. Revisional surgery was proposed in patients with insufficient excess weight loss (excess weight loss ≤50%) or weight regain after GB. A 1-step (1-step group, n = 270) or 2-step (2-step group, n = 88) approach was decided depending on patient's choice and/or surgeon's preference. The primary efficacy endpoint was the comparison of weight loss in the 1- and 2-step groups at the 2-year follow-up. The secondary efficacy endpoints were short-term outcomes (overall mortality and morbidity at postoperative day 30, specific morbidity, reoperation, length of hospital stay, and readmission). RESULTS: In the 1-step group, the mean preoperative body mass index before SG was 40.5 kg/m2 (27.0-69.0), while in the 2-step group, the mean preoperative body mass index was 43.5 kg/m2 (31.5-61.7). Mean operating time was 109 minutes (50-240) in the 1-step group and 78.7 minutes (40-175) in the 2-step group (P = .22). In the 1-step group, 6 conversions to laparotomy occurred, while in the 2-step group, 2 conversions to laparotomy occurred (P = .75). One death (.2%, in the 2-step group) and 39 complications (30 in the 1-step group [11.1%] and 9 in the 2-step group [10.2%]) also occurred. The mean length of hospital stay was 6.2 days in the 1-step group and 4.1 days in the 2-step group. At 2-year follow-up, mean body mass index was 32.4 kg/m2 in the 1-step group and 33.2 kg/m2 in the 2-step group (P = .15), representing excess weight losses of 61.9 and 50.1 (P = .05), respectively. The rates of revisional surgery were .7% and 2.2%, respectively. CONCLUSIONS: SG after previous GB is efficient with similar outcomes depending on the 1- or 2-step approach. The 1-step approach seems to have increased weight loss compared with the 2-step approach.

The Distance between the Pylorus and Left Vagus Nerve during Sleeve Gastrectomy.

The sleeve gastrectomy (SG) can be performed with or without antral preservation (distance from the pylorus <50 mm). The objective of this study was to evaluate the distance between the pylorus and the end of the left vagus nerve in order to determine whether it could be used as a constant anatomical landmark to start gastric transection. This was a prospective, nonrandomized study of 120 patients undergoing SG from January to October 2018. The distance measurement between pylorus and vagus nerve was performed at the beginning of the SG. The primary endpoint was the distance between the beginning of the pylorus and the end of the second branch of the vagus nerve on the upper edge of the antrum. The secondary endpoints was the correlation factors between the preoperative data and the position of the end of the vagus nerve. A total of 120 patients, with a mean body mass index of 42.2 kg/m2 , underwent primary SG. The mean distance between pylorus and the end of the vagus nerve was 50.4 mm (35-64) on the upper part of the antrum. When considering the inferior part of the antrum, the minimum distance was 50 mm. No correlations were found between preoperative data and distance measurements. The vagus nerve can be considered as a constant and reliable anatomical landmark for performing SG with antral preservation. However, no correlation was found between the preoperative data and the location of the end of the vagus nerve. Clin. Anat. 33:562-566, 2020. © 2019 Wiley Periodicals, Inc.

Health-related Quality of Life Following Hybrid Minimally Invasive Versus Open Esophagectomy for Patients With Esophageal Cancer, Analysis of a Multicenter, Open-label, Randomized Phase III Controlled Trial: The MIRO Trial.

BACKGROUND: Hybrid minimally invasive esophagectomy (HMIE) has been shown to reduce major postoperative complications compared with open esophagectomy (OE) for esophageal cancer. OBJECTIVES: The aim of this study was to compare short- and long-term health-related quality of life (HRQOL) following HMIE and OE within a randomized controlled trial. METHODS: We performed a multicenter, open-label, randomized controlled trial at 13 study centers between 2009 and 2012. Patients aged 18 to 75 years with resectable cancers of the middle or lower third of the esophagus were randomized to undergo either transthoracic OE or HMIE. Patients were followed-up every 6 months for 3 years postoperatively and global health assessed with EORTC-QLQC30 and esophageal symptoms assessed with EORTC-OES18. RESULTS: The short-term reduction in global HRQOL at 30 days specifically role functioning [-33.33 (HMIE) vs -46.3 (OE); P = 0.0407] and social functioning [-16.88 (HMIE) vs -35.74 (OE); P = 0.0003] was less substantial in the HMIE group. At 2 years, social functioning had improved following HMIE to beyond baseline (+5.37) but remained reduced in the OE group (-8.33) (P = 0.0303). At 2 years, increases in pain were similarly reduced in the HMIE compared with the OE group [+6.94 (HMIE) vs +14.05 (OE); P = 0.018]. Postoperative complications in multivariate analysis were associated with role functioning, pain, and dysphagia. CONCLUSIONS: Esophagectomy has substantial effects upon short-term HRQOL. These effects for some specific parameters are, however, reduced with HMIE, with persistent differences up to 2 years, and maybe mediated by a reduction in postoperative complications.

Clinicopathological and Molecular Study of Peritoneal Carcinomatosis Associated with Non-Small Cell Lung Carcinoma.

To retrospectively characterize the molecular features of Non-Small Cell Lung Carcinomas (NSCLC) with peritoneal carcinomatosis (PC), clinicopathological data of 12 patients diagnosed with NSCLC and PC between 2007 and 2016 were collected. Immunohistochemistry and Next Generation Sequencing (NGS) were performed on cases with available material. PC was the initial presentation of NSCLC in 17% of the cases. Overall, patients with PC displayed a poor median survival of 12 weeks. Histology was adenocarcinoma in 11 cases. 37.5% of cases showed PD-L1 immunostaining positivity (50% cut-off). ALK and ROS1 immunostainings were negative. Using NGS, we identified 17 molecular alterations in 9 genes (TP53, KRAS, STK11, BRAF, EGFR, DDR2, ERBB4, SMAD4, CTNNB1) in 88.9% of adenocarcinomas. To the best of our knowledge, 5 of these variants are not referenced in the literature. In conclusion, PC might be the initial presentation of NSCLC. Molecular profiling of our cases did not find any effective targetable alteration, except from high PD-L1 expression.

Video Report: "Laparoscopic Reversal of Roux-en-Y Gastric Bypass to Normal Anatomy".

BACKGROUND: Roux-en-Y gastric bypass (RYGB) is considered the gold standard for surgical management of morbid obesity due to its good results on weight loss and correction of comorbidities related to obesity. However, RYGB could have some adverse effect in the mid and long term. Here, we describe simple technique for laparoscopic reversal of RYGB into normal anatomy. METHODS: The video shows our laparoscopic technique of the reversal of RYGB that was performed for severe protein deficiency. A 35-year-old woman with history of RYGB was referred to our center for restoration of normal digestive anatomy. RESULTS: A 35-year-old woman was managed for severe protein deficiency 3 years after RYGB. Renutrition was performed using peripherally inserted central catheter but nutritional status was dependent on PICC. No gastrostomy tube was implemented at the time where the patient was referred because the reversal of RYGB was decided. We found a modified RYGB with a common channel of 130 cm, an alimentary channel of 350 cm, and a biliopancreatic limb of 70 cm. Revision to normal digestive anatomy was performed using linear staplers, resection of 15 cm of the small bowel, and only one small bowel anastomosis. An uneventful post-operative course enabled rapid discharge (post-operative day 5). At 6-month follow-up, there was no more protein deficiency and the patient had acceptable weight regain. CONCLUSION: Reversal of RYGB is not usual and can be performed safely with few small bowel sacrifices. The optimization of pre-operative nutritional status is necessary to avoid complications.