Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial).

BACKGROUND & AIMS: Endoscopic ultrasound-guided choledochoduodenostomy with a lumen-apposing metal stent (EUS-CDS) is a promising modality for management of malignant distal biliary obstruction (MDBO) with potential for better stent patency. We compared its outcomes with endoscopic retrograde cholangiopancreatography with metal stenting (ERCP-M). METHODS: In this multicenter randomized controlled trial, we recruited patients with MDBO secondary to borderline resectable, locally advanced, or unresectable peri-ampullary cancers across 10 Canadian institutions and 1 French institution. This was a superiority trial with a noninferiority assessment of technical success. Patients were randomized to EUS-CDS or ERCP-M. The primary end point was the rate of stent dysfunction at 1 year, considering competing risks of death, clinical failure, and surgical resection. Analyses were performed according to intention-to-treat principles. RESULTS: From February 2019 to February 2022, 144 patients were recruited; 73 were randomized to EUS-CDS and 71 were randomized to ERCP-M. The mean (SD) procedure time was 14.0 (11.4) minutes for EUS-CDS and 23.1 (15.6) minutes for ERCP-M (P < .01); 40% of the former was performed without fluoroscopy. Technical success was achieved in 90.4% (95% CI, 81.5% to 95.3%) of EUS-CDS and 83.1% (95% CI, 72.7% to 90.1%) of ERCP-M with a risk difference of 7.3% (95% CI, -4.0% to 18.8%) indicating noninferiority. Stent dysfunction occurred in 9.6% vs 9.9% of EUS-CDS and ERCP-M cases, respectively (P = .96). No differences in adverse events, pancreaticoduodenectomy and oncologic outcomes, or quality of life were noted. CONCLUSIONS: Although not superior in stent function, EUS-CDS is an efficient and safe alternative to ERCP-M in patients with MDBO. These findings provide evidence for greater adoption of EUS-CDS in clinical practice as a complementary and exchangeable first-line modality to ERCP in patients with MDBO. CLINICALTRIALS: gov, Number: NCT03870386.

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.

EUS-guided entero-colostomy with Lumen Apposing Metal Stent as a rescue treatment for malignant intestinal occlusion: a multicentre study.

BACKGROUND AND STUDY AIMS: Surgery is the first-choice treatment for malignant intestinal obstruction (MIO), however many patients are deemed unfit for surgery. Endoscopic ultrasound guided enterocolostomy (EUS-EC) with lumen apposing metal stents (LAMS) could represent a new treatment option. Primary aim was technical success of EUS-EC. Secondary aims: clinical outcome, safety, hospital stay. PATIENTS AND METHODS: Consecutive patients undergoing EUS-EC for MIO from November 2021 to September 2023 were retrospectively enrolled at four tertiary referral European centres. All cases were discussed in multidisciplinary meetings, patients declared unfit for surgery, colonic stent placement or refused surgery. RESULTS: Twelve patients were enrolled (58.3% female, median age 72.5 [42-85]). Colonic adenocarcinoma was the primary tumor in 75% of cases and 91.7% of patients had a Stage IV disease. Technical success was achieved in all procedures (100%). No LAMS misdeployment or other procedural adverse events and 3 (25%) severe post-procedural complications were observed. Clinical success was achieved in 10 (83.3%) patients, 5 (50%) resuming chemotherapy after procedure. Median post-procedural hospital stay was 9[1-20] days and overall median survival was 47.5[2-270] days. CONCLUSIONS: EUS-EC is a feasible technique and could be considered as a possible alternative to standard approaches for MIO in highly selected patients.

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.

EAES rapid guideline: updated systematic review, network meta-analysis, CINeMA and GRADE assessment, and evidence-informed European recommendations on the management of common bile duct stones.

BACKGROUND: Choledocholithiasis presents in a considerable proportion of patients with gallbladder disease. There are several management options, including preoperative or intraoperative endoscopic cholangiopancreatography (ERCP), and laparoscopic common bile duct exploration (LCBDE). OBJECTIVE: To develop evidence-informed, interdisciplinary, European recommendations on the management of common bile duct stones in the context of intact gallbladder with a clinical decision to intervene to both the gallbladder and the common bile duct stones. METHODS: We updated a systematic review and network meta-analysis of LCBDE, preoperative, intraoperative, and postoperative ERCP. We formed evidence summaries using the GRADE and the CINeMA methodology, and a panel of general surgeons, gastroenterologists, and a patient representative contributed to the development of a GRADE evidence-to-decision framework to select among multiple interventions. RESULTS: The panel reached unanimous consensus on the first Delphi round. We suggest LCBDE over preoperative, intraoperative, or postoperative ERCP, when surgical experience and expertise are available; intraoperative ERCP over LCBDE, preoperative or postoperative ERCP, when this is logistically feasible in a given healthcare setting; and preoperative ERCP over LCBDE or postoperative ERCP, when intraoperative ERCP is not feasible and there is insufficient experience or expertise with LCBDE (weak recommendation). The evidence summaries and decision aids are available on the platform MAGICapp ( https://app.magicapp.org/#/guideline/nJ5zyL ). CONCLUSION: We developed a rapid guideline on the management of common bile duct stones in line with latest methodological standards. It can be used by healthcare professionals and other stakeholders to inform clinical and policy decisions. GUIDELINE REGISTRATION NUMBER: IPGRP-2022CN170.

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.

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.

Long-term placement of lumen-apposing metal stent after endoscopic ultrasound-guided duodeno- and jejunojejunal anastomosis for direct access to excluded jejunal limb.

BACKGROUND: Management of biliary disorders in patients with altered anatomy may be challenging. Endoscopic ultrasound (EUS)-guided gastrointestinal anastomosis using a lumen-apposing metal stent (LAMS) was introduced to allow endoscopic retrograde cholangiography (ERC) in such cases. However, the appropriate stent indwelling time remains uncertain. We report long-term LAMS deployment after duodenojejunal or jejunojejunal anastomosis (EUS-DJA) to allow endoscopic reinterventions in cases of recurrences. METHODS: 11 consecutive patients underwent EUS-DJA with long-standing LAMS between January 2017 and December 2018. Over a 12-month period, ERC treatment was carried out with multiple endoscopic sessions across the DJA. RESULTS: Technical success was 91 % (10/11) for EUS-DJA and 100 % for ERC. Four patients presented stricture recurrence at a mean of 489 days (standard deviation [SD] 31.7) after the end of ERC treatment. A novel ERC across the LAMS anastomosis was feasible in all cases. At a mean of 781 days (SD 253.1), all LAMS remained in place with no evidence of complications. CONCLUSION: Long-term LAMS placement after EUS-DJA may be feasible and safe for direct access to the excluded limb.

Endoscopic ultrasound-guided drainage of intra-abdominal diverticular abscess. A case series.

AIM: Diverticular disease is widespread worldwide. Mainstay approach is non-operative treatment with bowel rest and broad-spectrum intravenous antibiotics. However, extra-colic abscess larger than 4 cm may require percutaneous trans-abdominal drainage. We report a single centre case series of patients underwent to trans-luminal endoscopic ultrasound (EUS)-guided drainage of pelvic abscess in diverticular disease with temporary placement of lumen apposing metal stent (LAMS). METHODS: All patients referred to our tertiary centre from January 2019 to July 2020 were enrolled in a prospective data base that was retrospectively analysed. Procedural steps were as follows: pre-operative computed tomography scan, broad-spectrum antibiotic therapy, EUS-guided deployment of LAMS for 15 days, LAMS removal and deployment of pigtail stent in case of pseudo-cavity persistence. RESULTS: Ten patients (6F) with an average of 59.6 years were enrolled with deployment of 10 LAMS. One patient was excluded after EUS evaluation and 1 patient had 2 LAMS for 2 separate abscesses. Technical and clinical success was achieved in 88.8% (8/9). CONCLUSIONS: Management of diverticulitis has shifted from primary surgical intervention towards a non-operative approach of bowel rest and broad-spectrum intravenous antibiotics in conjunction with interventional procedures to drain abscesses whenever necessary. EUS-guided drainage with LAMS for the management of diverticular abscesses seems an efficient treatment modality for encapsulated abscesses more than 4 cm in size and close to colonic wall. In expert centres, it may avoid radiologic intervention and/or surgery in a relevant percentage of cases.

Difficult biliary stones in the elderly: Endoscopic retrograde cholangiography - A single surgical tertiary centre experience with follow-up.

BACKGROUND: Pancreaticobiliary diseases and choledocholithiasis are common in elderly patients. Endoscopic treatment of biliary stones represents a well-established mini-invasive technique. However, limited data are available regarding the treatment of 'difficult' biliary stones, especially in the elderly population. The aim of our study is to evaluate the efficacy and safety of therapeutic endoscopic retrograde cholangiopancreatography (ERCP) in patients ≥85 years of age with complex biliary stones. MATERIALS AND METHODS: From January 2015 to January 2017, data from ERCP procedures performed for complex biliary stones were retrospectively collected. The patients were divided into two groups based on their age: Group A - aged 85 years or older (n = 110) and Group B - aged 65 years or younger (n = 62). Demographic data, success, complications and recurrence rates for both groups were reported. RESULTS: Chronic comorbidities (86.3% vs. 24.2%; P < 0.001) and use of antithrombotic drugs (48.2% vs. 19.3%; P < 0.001) were more frequent in the elderly. The technical success rate (95.4% vs. 96.7%; P > 0.6) and complication rate (8.2% vs. 13%; P > 0.2) were not statistically different among the two groups. Periampullary diverticula (PAD) were observed more frequently in Group A (38.1% vs. 17.7%; P < 0.006). More patients from Group B underwent cholecystectomy during the same admission (8.2% vs. 42.3%; P < 0.001). The recurrence rate was not different among the groups (7.6% vs. 5%; P > 0.5). PAD was identified as the risk factor for recurrence (P < 0.02). CONCLUSION: ERCP in the elderly was found to be a safe procedure, carrying a high degree of success for the treatment of difficult biliary stones.

Total Laparoscopic Pancreaticoduodenectomy with Venous Reconstruction for Pancreatic Head Cancer with Involvement of the Superior Mesenteric Vein-Portal Vein Confluence.

BACKGROUND: Laparoscopic pancreaticoduodenectomy with venous reconstruction is not commonly performed due to its technical challenges. In this video, we focus on the technical aspects for how to perform this procedure safely. METHODS: In a 69-year-old female with jaundice and diarrhea, a computed tomography scan showed a mass in the head of the pancreas, with a 180-degree involvement of the superior mesenteric vein. Endoscopic retrograde cholangiopancreatography with stenting was performed together with endoscopic ultrasound and fine-needle aspiration. Biopsy showed well-differentiated adenocarcinoma. The patient underwent six cycles of neoadjuvant chemotherapy, with reduction of the vein involvement to 90 degrees. The mass invaded the right lateral aspect of the superior mesenteric vein-portal vein confluence. As a result, this portion of the vein was removed en bloc with the specimen. The vascular defect was repaired using two running sutures. Once the choledocojejunostomy and intussuscepted pancreatico-gastric anastomosis were completed, the specimen was removed via a small subxiphoid incision. RESULTS: Operative time was 6 h and 30 min, blood loss was 50 mL, and hospital stay was 12 days. Histopathological examination was ypT3 N1 (1 of 18 lymph nodes was positive). All margins were negative. CONCLUSION: Laparoscopic pancreaticoduodenectomy with vascular reconstruction can be performed safely in selected cases of pancreatic head cancer with vein involvement. Advanced laparoscopic skills are necessary to complete such procedures safely.

Recurrence patterns after laparoscopic resection of colorectal liver metastases.

BACKGROUND: The major issue after liver resection for colorectal liver metastases (CRLM) is the high incidence of recurrence. Unlike open liver resection (OLR), recurrence following laparoscopic liver resection (LLR) is not well documented. The aim of this study was to analyze recurrence patterns and treatment following LLR for CRLM. STUDY DESIGN: All patients who underwent LLR for CRLM from 2000 to 2016 were reviewed. Patients who presented with recurrence were compared to those who did not. Recurrence-free survival (RFS), overall survival (OS), and risk of recurrence and survival prognostic factors were analyzed. RESULTS: Overall, 273 patients were included, of which 157 (57.5%) were treated for one liver metastasis (LM). Median follow-up was 41 (12-187) months and associated extrahepatic disease was present in 27% of patients (mainly pulmonary, 65%). After a median of 16 (3-151) months, 197 (72%) patients presented with recurrence. Recurrences were early (< 6 months) in 22.8% of cases, occured in a single site in 66% and were intrahepatic, extrahepatic, or both in 44, 30, and 26%, respectively. Recurrences were treated with surgery or chemotherapy only in 45 and 47%, respectively. 3-, 5-, and 10-year OS was 82, 71, and 43%, respectively. Independent risk factors for recurrence were node-positive primary tumor, extrahepatic disease before hepatectomy, and R1 resection. CONCLUSION: LLR for CRLM does not seem to be associated with distinctive recurrence patterns. LLR for CRLM yielded satisfying RFS and OS and should therefore be considered whenever possible.

Endoscopic transmural management of abdominal fluid collection following gastrointestinal, bariatric, and hepato-bilio-pancreatic surgery.

BACKGROUND: Post-operative collections are a recognized source of morbidity after abdominal surgery. Percutaneous drainage is currently considered the standard treatment but not all collections are accessible using this method. Since the adoption of EUS, endoscopic transmural drainage has become an attractive option in the management of such complications. The present study aimed to assess the efficacy, safety and modalities of endoscopic transmural drainage in the treatment of post-operative collections. METHODS: Data of all patients referred to our dedicated multidisciplinary facility from 2014 to 2017 for endoscopic drainage of symptomatic post-operative collections after failure of percutaneous drainage or when it was deemed impossible, were retrospectively analyzed. RESULTS: Thirty-two patients (17 males and 15 females) with a median age of 53 years old (range 31-74) were included. Collections resulted from pancreatic (n = 10), colorectal (n = 6), bariatric (n = 5), and other type of surgery (n = 11). Collection size was less than 5 cm in diameter in 10 (31%), between 5 and 10 cm in 17 (53%) ,and more than 10 cm in 5 (16%) patients. The median time from surgery to endoscopic drainage was 38 days (range 6-360). Eight (25%) patients underwent endoscopic guided drainage whereas 24 (75%) patients underwent EUS-guided drainage. Technical success was 100% and clinical success was achieved in 30 (93.4%) after a mean follow-up of 13.5 months (1.2-24.8). Overall complication was 12.5% including four patients who bled following trans-gastric drainage treated with conservative therapy. CONCLUSIONS: The present series suggests that endoscopic transmural drainage represents an interesting alternative in the treatment of post-operative collection when percutaneous drainage is not possible or fails.

Laparoscopic extended liver resection: are postoperative outcomes different?

BACKGROUND: Although laparoscopic major hepatectomy (LMH) is becoming increasingly common in specialized centers, data regarding laparoscopic extended major hepatectomies (LEMH) and their outcomes are limited. The aim of this study was to compare the perioperative characteristics and postoperative outcomes of LEMH to standard LMH. METHODS: All patients who underwent purely laparoscopic anatomical right or left hepatectomy and right or left trisectionectomy between February 1998 and January 2016 are enrolled. Demographic, clinicopathological, and perioperative factors were collected prospectively and analyzed retrospectively. Perioperative characteristics and postoperative outcomes in LEMH were compared to those of standard LMH. RESULTS: Among 195 patients with LMH, 47 (24.1%) underwent LEMH, colorectal liver metastases representing 66.7% of all indications. Preoperative portal vein embolization was undertaken in 31 (15.9%) patients. Despite more frequent vascular clamping, blood loss was higher in LEMH group (400 vs. 214 ml; p = 0.006). However, there was no difference in intraoperative transfusion requirements. Thirty-one patients experienced liver failure with no differences between LMH and LEMH groups. Postoperative mortality was comparable in the two groups [3 (2.5%) LMH patients vs. 2 (5%) LEMH patients (p = 0.388)]. Overall morbidity was higher in the LEMH group [49 LMH patients (41.5%) vs. 24 LEMH patients (60%) (p = 0.052)]. Patients treated with left LEMH experienced more biliary leakage (p = 0.011) and more major pulmonary complications (p = 0.015) than left LMH. CONCLUSION: LEMH is feasible at the price of important morbidity, with manageable and acceptable outcomes. These exigent procedures require high-volume centers with experienced surgeons.

Specific features of colorectal cancer in patients with metabolic syndrome: a matched case-control analysis of 772 patients.

PURPOSE: Although association between colorectal cancer (CRC) and metabolic syndrome (MetS) is established, specific features of CRC arising in patients presenting with MetS have not been clearly identified. METHOD: All patients who underwent colectomy for CRC from January 2005 to December 2014 at Institut Mutualiste Montsouris were identified from a prospectively collected database and characteristics were compared in the entire population and in a 1:2 matched case-control analysis [variables on which matching was performed were CRC localization (right- or left-sided) and AJCC stage (0 to IV)]. RESULTS: Out of the 772 identified patients, 98 (12.7%) presented with MetS. Entire population analysis revealed that CRC associated with MetS was more frequent in men (71.4 vs. 47.8%, p < 0.001), more often right-sided (71.4 vs. 50.4%, p < 0.001) and presented with less synchronous liver metastasis (4.1 vs. 8.7%, p = 0.002). Case-control analysis confirmed the gender association (p < 0.001) and showed HNPCC (p < 0.001) and history family of CRC (p = 0.010) to be significantly more frequent in Non-MetS patients. CONCLUSIONS: CRC associated with MetS is more frequent in men, more often right-sided, and presents with fewer synchronous metastasis. Further investigations should be designed in order to confirm these results and to enhance our knowledge of carcinogenesis related to MetS.