American Society for Gastrointestinal Endoscopy-European Society of Gastrointestinal Endoscopy guideline on primary endoscopic bariatric and metabolic therapies for adults with obesity.

This joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥ 30 kg/m2, or with a BMI of 27.0-29.9 kg/m2 with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.

American Society for Gastrointestinal Endoscopy-European Society of Gastrointestinal Endoscopy guideline on primary endoscopic bariatric and metabolic therapies for adults with obesity.

This joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥30 kg/m2, or with a BMI of 27.0-29.9 kg/m2 with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.

Does the presence of an esophageal motor disorder influence the response to anti-reflux mucosectomy (ARMS) for refractory GERD?

INTRODUCTION: The prevalence of esophageal motor disorders (EMD) in PPI-refractory gastroesophageal reflux disease (GERD) is substantial. However, limited data exist on their impact on the efficacy of endoscopic treatments like anti-reflux mucosectomy (ARMS). This study aimed to evaluate the influence of EMD on ARMS efficacy in patients with PPI-refractory GERD. METHOD: This single-center retrospective study enrolled patients with refractory GERD treated with ARMS-b (anti-reflux mucosectomy band-ligation). High-resolution esophageal manometry (HREM) was conducted before the procedure to identify EMD presence. The primary endpoint was treatment efficacy, defined as >50% improvement in GERD-HRQL score at 1 year. Secondary endpoints included PPI intake, symptom control, ARMS complications, and overall patient satisfaction at 12 months. RESULTS: The study included 65 patients, with 41 (63.1%) showing EMD on HREM. Treatment efficacy was achieved by 33.8% (22) of patients, with 8 without EMD, 11 having isolated LES hypotonia, and 3 with both LES hypotonia and esophageal body motor disorder. No significant differences were observed between patients with and without EMD regarding the primary endpoint, PPI use, symptom control, or complications. Dysphagia developed in 52.3% (34) within 6 months, leading to esophageal dilatation in 15.3% (10). Two patients experienced acute hemorrhage, and one had perforation. CONCLUSION: The presence of esophageal motor disorders does not seem to impact ARMS response, suggesting the technique's consideration in this population. Larger studies are essential for confirming these results and exploring treatment response and post-operative predictors.

Mid-gastric peroral endoscopic myotomy in the treatment of post-sleeve gastrectomy gastric tube twist: Four cases.

Background and study aims Laparoscopic sleeve gastrectomy (LSG) may lead to symptomatic mid-gastric twist in 0.1% to 4% of cases. Endoscopic balloon dilatation often fails, requiring a switch to Roux-en-Y bypass. Submucosal endoscopic treatment is expanding, so we propose a new technique of fibrosis incision after tunnelization, called medio-gastric peroral endoscopic myotomy (MG-POEM). Patients and methods Four patients aged 41 to 70 years underwent MG-POEM in 2020 for symptomatic post-LSG medio-gastric twist. The aim was to describe the technique, and document the efficacy, using the Gastric Outlet Obstruction Scoring System (GOOSS) score and a quality-of-life scale (QOLS). The procedures consisted of a POEM with myotomy and fibrosis incision. Results Median preoperative GOOSS and QOLS were 1/3 ([0-3] and 1.75/10 [0-10], respectively. All procedures were technically successful. One patient had immediate postoperative complications, which were treated conservatively. The median follow-up was 18 months. All patients had improved quality of life and food intake, with median postoperative GOOSS and QOLS of 3/3 and 6,5/10 [6-8], respectively. Two patients required additional pneumatic dilatation for scarring strictures. Follow-up endoscopies and esophagograms showed that the twist had disappeared. Conclusions MG-POEM shows promise for safe and effective management of post-LSG mid-gastric twist, despite requiring a high level of endoscopic skill to perform submucosal tunneling.

Gastric peroral endoscopic myotomy versus botulinum toxin injection for the treatment of refractory gastroparesis: results of a double-blind randomized controlled study.

INTRODUCTION: Gastric peroral endoscopic myotomy (G-POEM) is a promising technique for treating refractory gastroparesis. We present the first double-blind randomized study comparing the clinical efficacy of G-POEM versus pyloric botulinum toxin injection (BTI). METHODS: This randomized study, conducted in two expert centers, enrolled patients with refractory gastroparesis, medically managed for >6 months and confirmed by gastric emptying scintigraphy (GES), into two groups, G-POEM versus BTI, with follow-up of 1 year. The primary end point was the 3-month clinical efficacy, defined as a >1-point decrease in the mean Gastroparesis Cardinal Symptom Index (GCSI) score. Secondary end points were: 1-year efficacy, GES evolution, adverse events, and quality of life. RESULTS: 40 patients (22 women; mean age 48.1 [SD 17.4]), with mean symptom duration of 5.8 (SD 5.7) years, were randomized. Etiologies included idiopathic (n=18), diabetes (n=11), postoperative (n=6), and mixed (n=4). G-POEM showed a higher 3-month clinical success than BTI (65% vs. 40%, respectively; P=0.10), along with non-significantly higher 1-year clinical success (60% vs. 40%, respectively) on intention-to-treat analysis. The GCSI decreased in both groups at 3 months and 1 year. Only three minor adverse events occurred in the G-POEM group. The GES improvement rate was 72% in the G-POEM group versus 50% in the BTI group (non-significant). CONCLUSION: G-POEM seems to have a higher clinically relevant success rate than BTI, but this was not statistically demonstrated. This study confirms the interest in treatments targeting the pylorus, either mechanically or chemically, for managing refractory gastroparesis.

EUS-guided Gastroenterostomy: A Multicenter International Study Comparing Benign and Malignant Diseases.

BACKGROUND: Endoscopic ultrasound (EUS)-guided gastroenterostomy (EUS-GE) is a minimally invasive therapy for patients with gastric outlet obstruction without the risks of surgical bypass and the limited long-term efficacy of enteral self-expanding metal stent placement. However, due to its novelty, there is a lack of significant data comparing long-term outcomes of patients with EUS-GE, based on the underlying disease. In this study, we compare outcomes of EUS-GE on benign versus malignant indications. METHODS: Consecutive patients from 12 international, tertiary care centers who underwent EUS-GE over 3 years were extracted in a retrospective registry. Demographic characteristics, procedure-related information and follow-up data was collected. Primary outcome was the rate of adverse events associated with EUS-GE and the comparison of the rate of adverse events in benign versus malignant diseases. Secondary outcomes included technical and clinical success as well as hospitalization admission. RESULTS: A total of 103 patients were included: 72 malignant and 31 benign. The characteristics of the patients undergoing EUS-GE is shown in Table 1. The mean age of the cohort was 68 years and 58 years for malignant and benign etiology. Gender distribution was 57% and 39% being females in malignant and benign etiology group, respectively. Clinical success, technical success, average procedure time, and hospital length of stay were similar in both groups. Patients with benign underlying etiology had significantly higher number of surgically altered midgut anatomy (P=0.0379). CONCLUSION: EUS-GE is equally efficient regardless of the underlying etiology (malignant vs. benign), and the adverse events both groups were comparable.

Endoscopic ultrasound-guided gastroenterostomy with lumen-apposing metal stents: a retrospective multicentric comparison of wireless and over-the-wire techniques.

BACKGROUND: Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) using lumen-apposing metal stents (LAMSs) appears to be effective and safe in gastric outlet obstruction (GOO); however, the EUS-GE procedure is not standardized, with the use of assisted or direct methods still debated. The aim of this study was to compare the outcomes of EUS-GE techniques focusing on an assisted with orointestinal drain wireless endoscopic simplified technique (WEST) and the nonassisted direct technique over a guidewire (DTOG). METHOD: This was a multicenter European retrospective study involving four tertiary centers. Consecutive patients who underwent EUS-GE for GOO between August 2017 and May 2022 were included. The primary aim was to compare the technical success and adverse event (AE) rates of the different EUS-GE techniques. Clinical success was also analyzed. RESULTS: 71 patients (mean [SD] age 66.2 10 years; 42.3 % men; 80.3 % malignant etiology) were included. Technical success was higher in the WEST group (95.1 % vs. 73.3 %; estimate of relative risk from odds ratio (eRR) 3.2, 95 %CI 0.94-10.9; P = 0.01). The rate of AEs was lower in the WEST group (14.6 % vs. 46.7 %; eRR 2.3, 95 %CI 1.2-4.5; P = 0.007). Clinical success was comparable between the two groups at 1 month (97.5 % vs. 89.3 %). The median follow-up was 5 months (range 1-57). CONCLUSION: The WEST resulted in a higher technical success rate with fewer AEs, with clinical success comparable with the DTOG. Therefore, the WEST (with an orointestinal drain) should be preferred when performing EUS-GE.

Risk factors for EUS-guided radiofrequency ablation adverse events in patients with pancreatic neoplasms: a large national French study (RAFPAN study).

BACKGROUND AND AIMS: EUS-guided radiofrequency ablation (EUS-RFA) has been described as a potentially curative option for solid and cystic pancreatic neoplasms. We aimed to assess the safety and efficacy of pancreatic EUS-RFA in a large study population. METHODS: A retrospective study retrieving all consecutive patients who underwent pancreatic EUS-RFA during 2019 and 2020 in France was conducted. Indication, procedural characteristics, early and late adverse events (AEs), and clinical outcomes were recorded. Risk factors for AEs and factors related to complete tumor ablation were assessed on univariate and multivariate analyses. RESULTS: One hundred patients (54% men, 64.8 ± 17.6 years old) affected by 104 neoplasms were included. Sixty-four neoplasms were neuroendocrine neoplasms (NENs), 23 were metastases, and 10 were intraductal papillary mucinous neoplasms with mural nodules. No procedure-related mortality was observed, and 22 AEs were reported. Proximity of pancreatic neoplasms (≤1 mm) to the main pancreatic duct was the only independent risk factor for AEs (odds ratio [OR), 4.10; 95% confidence interval [CI), 1.02-15.22; P = .04). Fifty-nine patients (60.2%) achieved a complete tumor response, 31 (31.6%) a partial response, and 9 (9.2%) achieved no response. On multivariate analysis, NENs (OR, 7.95; 95% CI, 1.66-51.79; P < .001) and neoplasm size <20 mm (OR, 5.26; 95% CI, 2.17-14.29; P < .001) were independently related to complete tumor ablation. CONCLUSIONS: The results of this large study confirm an overall acceptable safety profile for pancreatic EUS-RFA. Close proximity (≤1 mm) to the main pancreatic duct represents an independent risk factor for AEs. Good clinical outcomes in terms of tumor ablation were observed, especially for small NENs.

Training in esophageal peroral endoscopic myotomy (POEM) on an ex vivo porcine model: learning curve study and training strategy.

BACKGROUND: Peroral endoscopic myotomy (POEM) is a very effective treatment for achalasia. However, training remains non-standardized. We evaluated a training curriculum, including ex vivo cases, followed by patients' cases under expert supervision. The objective was to establish a learning curve of POEM. MATERIALS AND METHODS: Four operators having completed advanced endoscopy fellowship were involved. They had already observed > 30 cases performed by experts. They performed 30 POEMs standardized (tunnel and myotomy lengths) procedures on ex vivo porcine model. Procedural times, number/volume of injections, mucosal and serous perforations, and myotomy length were collected. The learning curve was assessed using dissection speed (DS) and a dedicated performance score (PS), including learning rate (LR) and learning plateau (LP). RESULTS: The operators completed all cases within 4 months (median of 3.5 cases/week). The mean procedural time was 43.3 min ± 14.4. Mean myotomy length was 70.0 mm ± 15.6 mm. Dissection speed averaged 1.78 mm/min ± 0.78. Using DS and PS as parameter, the LR was reached after 12.2 cases (DS = 2.0 mm/min) and 10.4 cases, respectively. When comparing the LP and the plateau phase, the DS was slower (1.3 ± 0.5 mm/min versus 2.1 ± 0.54 mm/min, p < 0.005) and perforations were decreased: 0.35 ± 0.82 in LP vs. 0.16 ± 0.44 in PP. Following this training, all operators performed 10 supervised cases and are competent in POEM. CONCLUSION: The association of observed cases and supervised ex vivo model training is effective for starting POEM on patients. The learning curve is 12 cases to reach a plateau.

EUS-guided hepaticogastrostomy in patients with obstructive jaundice after failed or impossible endoscopic retrograde drainage: A multicenter, randomized phase II Study.

Background and Objectives: Over the last two decades, EUS-guided hepaticogastrostomy (EUS-HGS) has emerged as a therapeutic alternative for patients with biliary obstruction and failed ERCP. Percutaneous transhepatic biliary drainage (PTBD) as the gold standard is associated with relevant morbidity and need for re-intervention. The aim of our work was to evaluate in a phase II study the safety and efficacy profile of EUS-HGS. A PTBD arm was considered a control group. Patients and Methods: We conducted a prospective, randomized, noncomparative phase II study in three French tertiary centers involving patients with benign or malignant obstructive jaundice after failure of ERCP. Patients were randomized to either PTBD or EUS-HGS. Results: Fifty-six patients (mean age 64 years) have been included between 2011 and 2015. Twenty-one underwent PTBD and thirty-five were drained using EUS-HGS. An interim analysis after the inclusion of 41 patients revealed an unexpected high 30-day morbidity rate for PTBD (13 out of 21 patients), justifying to stop randomization and inclusion in this control arm in 2013. The primary objective was reached with 10 out of the 35 EUS-HGS patients (28.6%) having observed complications (90%-level bilateral exact binomial confidence interval [CI] [16.4%-43.6%], left-sided exact binomial test to the objectified 50% unacceptable rate P = 0.0083). Both methods achieved comparable technical success rate (TSR) and clinical success rate (CSR) (TSR: PTBD 100% vs. EUS-HGS 94.3%, P = 0.28; CSR: PTBD 66.7% vs. EUS-HGS 80%, P = 0.35). Long-term follow-up showed EUS-HGS patients being at lower risk for re-intervention (relative risk = 0.47, 95% CI [0.27-0.83]). Conclusion: In cases of ERCP failure, EUS-HGS is a valuable alternative for biliary drainage with a high TSR and CSR. PTBD is associated with an unacceptable 30-day morbidity rate, whereas EUS-HGS seems to have a decent safety profile, suggesting that it may be the treatment of choice in appropriately selected patients.

Feasibility of a new bariatric fully endoscopic duodenal-jejunal bypass: a pilot study in adult obese pigs.

This study assessed a new natural orifice transluminal endoscopic surgery (NOTES) bariatric endoscopic procedure in obese adult pigs. This 14-week prospective study compared 6 adult male Yucatan test pigs with baseline mean age 1.5 years to 2 control pigs. The test pigs received a fully endoscopic NOTES-based duodenal-jejunal bypass including measurement of the bypassed limb and creation of a gastrojejunal anastomosis (GJA) using a gastrojejunal lumen-apposing metal stent (GJ-LAMS) at Week 0, placement of a duodenal exclusion device (DED) at Week 2, and endoscopic examinations at Weeks 6 and 10. At Week 14, the pigs were sacrificed for necropsy. All endoscopic procedures were technically successful. By Week 14, the controls had gained a mean 1.1 ± 2.1 kg (+ 1.6%) while the intervention animals lost a mean 6.8 ± 3.9 kg (- 10.5%) since baseline. GJ-LAMS migrations occurred in 3 pigs, two of which also had DED migration and/or partial dislocation. Two other pigs died, one with aberrant splenic vein positioning near the GJA and the other from an unknown cause. An endoscopic bariatric bypass procedure with controlled bypass length was technically successful in all the cases and led to weight loss in test animals. Safety concerns must be further addressed.

Impact of antibiotic prophylaxis and conditioning modalities in per-oral endoscopic myotomy for esophageal motor disorders.

BACKGROUND AND AIMS: No recommendation regarding antibiotic prophylaxis and preparation modalities are available for patients with esophageal motor disorders who benefit from Per-Oral Endoscopic Myotomy (POEM). The aim of our study was to evaluate their impact on the POEM's safety. PATIENTS AND METHODS: This study was a comparative and multicentric retrospective analysis of a database prospectively collected. Patients over 18 years old with esophageal motor disorders confirmed by prior manometry, who underwent POEM were included. The primary endpoint was the occurrence of adverse events, as classified by Cotton, based on whether or not antibiotic prophylaxis was administered. RESULTS: A total of 226 patients (median age 52.9 ± 19.12 years [18-105], 116 women [51.3%]) were included. The indication for POEM was mainly type 2 achalasia (n = 135, 60.3%). Antibiotic prophylaxis was administered to 170 patients (75.2%) during 3.93 ± 3.46 days [1-21]. The overall adverse events rate was 9.3% (n = 21). Antibiotic prophylaxis was associated with the occurrence of adverse events (p = .003), but had no impact on their severity (p = .238). Antibiotic prophylaxis didn't influence the effectiveness of POEM (1 [0-4] vs 1 [0-9], p = .231). The use of a liquid diet in the 48 h prior to the procedure was significantly associated with a lower adverse events rate (3.1% vs 6.19%, p = .0002). CONCLUSION: The antibiotic prophylaxis during POEM does not prevent adverse events, had no impact on their severity and the efficacy of the procedure. A liquid diet before the procedure should be systematically proposed.

Evaluation of the ex-vivo porcine simulator on EUS-guided cystogastrostomy using lumen-apposing metal stent training.

Bckground and Objectives: EUS-guided cystogastrostomy is a well-established advanced endoscopic technique with a steep-learning curve which necessitates an ex-vivo simulator that would allow for adequate training. The aim of this study is to evaluate the feasibility of the model in allowing training for EUS-guided cystogastrostomy using lumen-apposing metal stent (LAMS). Subjects and Methods: The model was created by ROEYA Training Center, Egypt, using native porcine tissue to create fluid collections simulating both cystic and solid lesions. It was designed and tested in advance while the hydrogel was added on-site. The simulator was evaluated prospectively in five training sessions involving 17 international experts. The task was to successfully deploy the LAMS to drain the created cyst. After using the simulator, the experts were asked to fill a questionnaire to assess their experience. The primary endpoint was overall satisfaction with the model as a training tool. Results: All of the experts were satisfied with the model as a tool to train endoscopists for the technique. 76.5% (n = 11) of the experts thought the model to be moderately realistic. Proper visualization was reported by 94.1% of the experts. All experts believed the lesions to be either slightly like or very similar to real lesions. The model was graded "easy" in difficulty by 11 of the experts. Conclusions: In all parameters assessed, the experts thought the model to be a useful tool for future training. This preliminary study suggests that the aforementioned simulator can be used to train endoscopists on using LAMS in a risk-free environment.

Feasibility of Conversion of a New Bariatric Fully Endoscopic Bypass Procedure to Bariatric Surgery: a Porcine Pilot Study.

PURPOSE: Bariatric endoscopic procedures are emerging as alternatives to bariatric surgical procedures. This study aimed to assess if a natural orifice transluminal endoscopic surgery (NOTES) bariatric procedure could be converted to a surgical duodenal-jejunal bypass (DJB) or sleeve gastrectomy (SG). MATERIALS AND METHODS: This 12-week prospective study compared 4 test pigs to 3 control (no procedures) pigs aged 3 months at baseline. The test pigs received a fully endoscopic NOTES-based bypass including measurement of the bypassed limb and creation of a gastrojejunal anastomosis (GJA) using gastrojejunal lumen-apposing metal stents (GJ-LAMS) at Week 0, placement of a duodenal exclusion device (DED) at Week 2, and randomization to DJB or SG surgery at Week 8 with subsequent 4-week follow-up. At Week 12, the pigs were sacrificed and necropsy was performed. RESULTS: Endoscopic procedures were technically successful. One pig did not receive a DED due to early GJ-LAMS migration leading to premature closure of the GJA. At Week 8, all 4 pigs were doing well, and the remaining 3 GJ-LAMS and 3 DEDs were uneventfully endoscopically removed. Two one-anastomosis DJB were performed, and 2 SG were performed, closing in one case the site of the previous GJA. The surgical procedures were technically feasible and uneventful during follow-up. Necropsy assessments showed no local or peritoneal inflammation or abscess and no leakage or fistula. CONCLUSION: An endoscopic bariatric bypass can be transitioned to a one-anastomosis duodenal-jejunal bypass or sleeve gastrectomy, without complications.

Endoscopic ultrasound-guided drainage using lumen-apposing metal stent of malignant afferent limb syndrome in patients with previous Whipple surgery: Multicenter study (with video).

OBJECTIVES: Endoscopic ultrasound-guided digestive anastomosis (EUS-A) is a new alternative under evaluation in patients presenting with afferent limb syndrome (ALS) after Whipple surgery. The aim of the present study is to analyze the safety and effectiveness of EUS-A in ALS. METHODS: This is an observational multicenter study. All patients ≥18 years old with previous Whipple surgery presenting with ALS who underwent an EUS-A using a lumen-apposing metal stent (LAMS) between 2015 and 2021 were included. The primary outcome was clinical success, defined as resolution of the ALS or ALS-related cholangitis. Furthermore, technical success, adverse event rate, and mortality were evaluated. RESULTS: Forty-five patients (mean age: 65.5 ± 10.2 years; 44.4% male) were included. The most common underlying disease was pancreatic cancer (68.9%). EUS-A was performed at a median of 6 weeks after local tumor recurrence. The most common approach used was the direct/freehand technique (66.7%). Technical success was achieved in 95.6%, with no differences between large (≥15 mm) and small LAMS (97.4% vs. 100%, P = 0.664). Clinical success was retained in 91.1% of patients. A complementary treatment by dilation of the stent followed by endoscopic retrograde cholangiopancreatography through the LAMS was performed in three cases (6.7%). There were six recurrent episodes of cholangitis (14.6%) and two procedure-related adverse events (4.4%) after a median follow-up of 4 months. Twenty-six patients (57.8%) died during the follow-up due to disease progression. CONCLUSION: EUS-A is a safe and effective technique in the treatment of malignant ALS, achieving high clinical success with an acceptable recurrence rate.

Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review.

1: ESGE recommends a prolonged course of a prophylactic broad-spectrum antibiotic in patients with ascites who are undergoing therapeutic endoscopic ultrasound (EUS) procedures.Strong recommendation, low quality evidence. 2: ESGE recommends placement of partially or fully covered self-expandable metal stents during EUS-guided hepaticogastrostomy for biliary drainage in malignant disease.Strong recommendation, moderate quality evidence. 3: ESGE recommends EUS-guided pancreatic duct (PD) drainage should only be performed in high volume expert centers, owing to the complexity of this technique and the high risk of adverse events.Strong recommendation, low quality evidence. 4: ESGE recommends a stepwise approach to EUS-guided PD drainage in patients with favorable anatomy, starting with rendezvous-assisted endoscopic retrograde pancreatography (RV-ERP), followed by antegrade or transmural drainage only when RV-ERP fails or is not feasible.Strong recommendation, low quality evidence. 5: ESGE suggests performing transduodenal EUS-guided gallbladder drainage with a lumen-apposing metal stent (LAMS), rather than using the transgastric route, as this may reduce the risk of stent dysfunction.Weak recommendation, low quality evidence. 6: ESGE recommends using saline instillation for small-bowel distension during EUS-guided gastroenterostomy.Strong recommendation, low quality evidence. 7: ESGE recommends the use of saline instillation with a 19G needle and an electrocautery-enhanced LAMS for EUS-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE) procedures.Strong recommendation, low quality evidence. 8: ESGE recommends the use of either 15- or 20-mm LAMSs for EDGE, with a preference for 20-mm LAMSs when considering a same-session ERCP.Strong recommendation, low quality evidence.

First fully endoscopic metabolic procedure with NOTES gastrojejunostomy, controlled bypass length and duodenal exclusion: a 9-month porcine study.

We conducted a pilot study of a potential endoscopic alternative to bariatric surgery. We developed a Natural Orifice Transluminal Endoscopic Surgery (NOTES) gastric bypass with controlled bypass limb length using four new devices including a dedicated lumen-apposing metal stent (GJ-LAMS) and pyloric duodenal exclusion device (DED). We evaluated procedural technical success, weight change from baseline, and adverse events in growing Landrace/Large-White pigs through 38 weeks after GJ-LAMS placement. Six pigs (age 2.5 months, mean baseline weight 26.1 ± 2.7 kg) had initial GJ-LAMS placement with controlled bypass limb length, followed by DED placement at 2 weeks. Technical success was 100%. GJ-LAMS migrated in 3 of 6, and DED migrated in 3 of 5 surviving pigs after mucosal abrasion. One pig died by Day 94. At 38 weeks, necropsy showed 100-240 cm limb length except for one at 760 cm. Weight gain was significantly lower in the pigs that underwent endoscopic bypass procedures compared to expected weight for age. This first survival study of a fully endoscopic controlled bypass length gastrojejunostomy with duodenal exclusion in a growing porcine model showed high technical success but significant adverse events. Future studies will include procedural and device optimizations and comparison to a control group.

Endoscopic internal drainage and low negative-pressure endoscopic vacuum therapy for anastomotic leaks after oncologic upper gastrointestinal surgery.

BACKGROUND: Endoscopic internal drainage (EID) with double-pigtail stents or low negative-pressure endoscopic vacuum therapy (EVT) are treatment options for leakage after upper gastrointestinal oncologic surgery. We aimed to compare the effectiveness of these techniques. METHODS: Between 2016 and 2019, patients treated with EID in five centers in France and with EVT in Göttingen, Germany were included and retrospectively analyzed using univariate analysis. Pigtail stents were changed every 4 weeks; EVT was repeated every 3-4 days until leak closure. RESULTS: 35 EID and 27 EVT patients were included, with a median (interquartile range [IQR]) leak size of 0.75 cm (0.5-1.5). Overall treatment success was 100 % (95 % confidence interval [CI] 90 %-100 %) for EID vs. 85.2 % (95 %CI 66.3 %-95.8 %) for EVT (P = 0.03). The median (IQR) number of endoscopic procedures was 2 (2-3) vs. 3 (2-6.5; P = 0.003) and the median (IQR) treatment duration was 42 days (28-60) vs. 17 days (7.5-28; P < 0.001), for EID vs. EVT, respectively. CONCLUSION: EID and EVT provide high closure rates for upper gastrointestinal anastomotic leaks. EVT provides a shorter treatment duration, at the cost of a higher number of procedures.

Evaluation of the performances of a single-use duodenoscope: Prospective multi-center national study.

OBJECTIVES: A single-use duodenoscope (SUD) has been recently developed to overcome issues with endoscopic retrograde cholangiopancreatography (ERCP)-related cross-infections. The aim was to evaluate SUD safety and performance in a prospective multi-centre study. METHODS: All consecutive patients undergoing ERCP in six French centers were prospectively enrolled. All procedures were performed with the SUD; in case of ERCP failure, operators switched to a reusable duodenoscope. Study outcomes were the successful completion of the procedure with SUD, safety and operators' satisfaction based on a VAS 0-10 and on 22 qualitative items. The study protocol was approved by French authorities and registered (ID-RCB: 2020-A00346-33). External companies collected the database and performed statistical analysis. RESULTS: Sixty patients (34 females, median age 65.5 years old) were enrolled. Main indications were bile duct stones (41.7%) and malignant biliary obstruction (26.7%). Most ERCP were considered ASGE grade 2 (58.3%) or 3 (35.0%). Fifty-seven (95.0%) procedures were completed using the SUD. Failures were unrelated to SUD (one duodenal stricture, one ampullary infiltration, and one tight biliary stricture) and could not be completed with reusable duodenoscopes. Median operators' satisfaction was 9 (7-9). Qualitative assessments were considered clinically satisfactory in a median of 100% of items and comparable to a reusable duodenoscope in 97.9% of items. Three patients (5%) reported an adverse event. None was SUD-related. CONCLUSIONS: The use of a SUD allows ERCP to be performed with an optimal successful rate. Our data show that SUD could be used for several ERCP indications and levels of complexity.