Endoscopic sutured gastroplasty in addition to lifestyle modification: short-term efficacy in a controlled randomised trial.

OBJECTIVE: Endoscopic suture gastroplasty (ESG) has been developed as an alternative treatment for moderately obese patients. We present our results of a short-term randomised controlled trial on a new suturing technique, the Endomina system (E-ESG, Endo Tools therapeutics, Belgium). DESIGN: Eligible patients (body mass index 30-40 kg/m2) were randomised in a 2:1 ratio to receive lifestyle modification plus E-ESG or lifestyle modification alone (control group); dietetic counselling and follow-up were identical. Endpoints included a mean excess weight loss (EWL) of more than 25% 12 months after E-ESG and a 15% EWL difference at 6 months between groups. At 6 months, a cross-over to E-ESG was offered to the control group. All patients were followed for a total of 12 months after E-ESG. RESULTS: Of the 71 patients included (five male, mean age 40 years), mean EWL at 6 months was significantly higher in the treatment (38.6%, n=45) than in the control group (13.4%, n=21; p<0.001). At 6 months, satiety tests demonstrated a higher decrease in mean volume (41% vs 2.5%, p<0.001), and mean quality of life (QoL) was also higher in the treatment group (52.8 vs 45.1 p<0.05). No procedure-related or device-related severe adverse events were observed. Twelve months follow-up after E-ESG showed a mean EWL of 45.1%, which translated into a total body weight loss of 11.8%. CONCLUSIONS: This study demonstrates that E-ESG is safe and effective, providing a 25% better EWL at 6 months than lifestyle modification alone. This weight loss was maintained and resulted in a significant improvement in QoL up to 18 months after treatment. TRIAL REGISTRATION NUMBER: NCT03255005.

Long-term outcomes of endoscopic treatment of aberrant hepatic duct injuries after cholecystectomy.

BACKGROUND AND AIMS: Right aberrant hepatic ducts are an anatomic variant with clinical relevance because of the risk of injury during cholecystectomy. Treatment options for aberrant hepatic duct injuries are not standardized. This study aims to analyze the long-term results of endoscopic treatment of aberrant hepatic duct lesions. METHODS: Patients who underwent ERCP for aberrant hepatic duct lesions were retrospectively identified. Demographic data, type of aberrant duct lesion according to the Strasberg classification, type of treatment (number of plastic stents inserted, treatment duration, and number of ERCPs), and adverse events were recorded. Follow-up was obtained by telephone contact or medical examinations. RESULTS: Between January 1996 and March 2019, 32 patients (78% women, mean age 51.7 years) with aberrant hepatic duct injuries underwent ERCP at our Endoscopy Unit. Six patients had Strasberg type B lesions, 11 patients had type C, and 8 patients had type E5, and 7 patients had a stenosis of the aberrant duct. A mean of 3.7 biliary plastic stents per patient were used; mean treatment duration was 6.3 months. All patients with isolated aberrant duct stenosis and 1 of 6 patients (17%) with type B Strasberg lesions achieved patency. Ten of 11 patients (91%) with type C Strasberg lesions achieved duct recanalization. After a mean follow-up of 109.3 ± 61.2 months, 29 of 32 patients (91%) were asymptomatic; 1 underwent surgery for recurrent cholangitis, 1 received a new endoscopic procedure because of cholangitis, and 1 reported episodic biliary colic without an increase in liver function test values and was successfully managed with a low-fat diet. CONCLUSIONS: An endoscopic approach to aberrant hepatic duct lesions after cholecystectomy can be considered an effective first-line therapy.

Impact of trainee involvement on the outcome of ERCP procedures: results of a prospective multicenter observational trial.

BACKGROUND: Training in advanced endoscopic techniques such as endoscopic retrograde cholangiopancreatography (ERCP) should be driven by key performance measures and standardized competence assessment in order to provide safe and high-quality interventions. We aimed to determine whether the involvement of trainees influences the outcome of the procedure and the incidence of ERCP-related adverse events. METHODS: This was an international, multicenter, prospective, observational study conducted at six high- and low-volume centers across Europe between October 2016 and October 2018, and included independent operators and their trainees. Standard report forms documenting indication, trainee involvement, technical outcome, and complications over a 30-day follow-up of consecutive ERCP procedures were included in the analysis. Technical success of the procedure and procedure-related adverse events were compared between procedures in the trainee group and the control group using bivariable and multivariable analysis. RESULTS: 21 trainees and 16 control endoscopists performed 1843 ERCPs during the study period. Trainee involvement in ERCP procedures did not decrease technical success (92.4 % vs. 93.7 %; P = 0.30) or increase the risk of adverse events (14.7 % vs. 14.6 %; P > 0.99). Conversely, there were significantly more moderate or severe adverse events in the control group compared with the trainee group (6.2 % vs. 3.4 %, P = 0.01). On multivariable analysis, only increased bilirubin levels, time to cannulation, and procedure difficulty level increased the risk of any procedure-related adverse event. CONCLUSION: Trainee involvement in ERCP interventions within a proper teaching setting is safe and does not compromise the success of the procedure.

Rare Case of Endoscopic Treatment for Bevacizumab-Related Gastric Perforation in a Patient with Ovarian Cancer.

Antiangiogenic chemotherapy is a common treatment option for patients with advanced ovarian cancer (OC) and has been proven to be effective and generally safe. Nevertheless, in rare cases, these drugs can give serious complications such as gastrointestinal perforations that can be even mortal or very difficult to treat and can heavily impact the clinical management. We present a rare case of bevacizumab-induced gastric perforation in a patient with advanced OC occurred during bevacizumab-including chemotherapy in an adjuvant setting. Surgical treatment was not possible due to the frailty of the clinical condition of the patient and the gastric perforation was successfully treated with endoscopic suturing.

Long-term follow-up after multiple plastic stenting for refractory pancreatic duct strictures in chronic pancreatitis.

BACKGROUND: Dominant pancreatic duct strictures in chronic pancreatitis are often managed by endoscopic placement of a single plastic stent. Insertion of multiple plastic stents (MPS) has been proven to be effective in managing refractory strictures, but data are still limited. The aim of this study was to investigate the efficacy and long-term results of MPS to dilate pancreatic duct strictures in chronic pancreatitis. METHODS: 48 patients (34 men; mean age 44 years) with chronic pancreatitis and a single pancreatic stent through a refractory stricture in the pancreatic head underwent the following protocol: 1) removal of the single pancreatic stent; 2) balloon dilation of the stricture; 3) insertion of the maximum number of stents; 4) stent removal after 6 - 12 months. RESULTS: The median number of pancreatic plastic stents placed was 3 (diameter 7 - 11.5 Fr, length 3 - 7 cm). Five patients (10.4 %) had persistent strictures after MPS removal. During a mean follow-up of 9.5 years (0.3 - 15.5 years) after stent removal, 74.4 % (32/43) of the patients were asymptomatic, and 25.6 % (11/43) experienced pancreatitis recurrence or pancreatic type pain after a mean time of 26.4 months (8/43, 18.6 % underwent plug extraction without evidence of stricture recurrence; 3/43, 7.0 % had stricture recurrence). No major complications were recorded. CONCLUSION: Endoscopic multiple plastic stenting of chronic pancreatitis-related pancreatic duct strictures showed satisfactory long-term results, with the option of re-treatment. This procedure can be considered an important therapeutic alternative for painful pancreatic duct strictures located in the head of the pancreas in the setting of chronic pancreatitis.

Right hepatic artery syndrome: report of three cases and literature review.

Anatomical variations of the hepatic artery have been described as responsible for the onset of jaundice or stone formation. We present three cases of intrahepatic stones secondary to a compression of the proximal common bile duct (CBD) by the right hepatic artery (RHA). Three consecutive patients (males, mean age 65 years) with symptoms of cholangitis and intra-hepatic stones admitted between October 2017 and June 2018 with a final diagnosis of CBD compression from the RHA. The three patients underwent ERCP and biliary sphincterotomy with extraction of intra-hepatic stones; after stone removal cholangiograhy showed CBD compression just below the main hepatic confluence which was confirmed to be secondary to RHA compression on subsequent MRI. The patients remained asymptomatic after 12 months mean follow-up. Compression of the CBD by the RHA might be responsible for intra-hepatic stone formation. Endoscopic treatment is feasible and effective on short-term follow-up.

Pancreas divisum and recurrent pancreatitis: long-term results of minor papilla sphincterotomy.

Background and aims: Pancreas divisum (PD) is the most common congenital variant of the pancreatic ductal system and a potential cause of acute recurrent pancreatitis (ARP). Endoscopic therapy is a therapeutic option for symptomatic PD, but there is limited data on long-term results. We aimed to assess the effect of minor papilla endoscopic sphincterotomy (MiES) in the setting of ARP in patients with PD. Methods: Consecutive patients treated by MiES were included. Clinical data, including gender, age, smoking and drinking habits, number of episodes of acute pancreatitis (AP) as well as technical data pertaining to the endoscopic therapy were reviewed. Patients available for follow-up were contacted to assess the long-term impact of MiES using the Patient's Global Impression of Change (PGIC) questionnaire. Results: A total of 138 patients with PD including 77 patients with ARP underwent MiES; 48 patients were available for long-term follow-up using the PGIC score, with a mean follow-up period of 9.7 years. Procedure-related adverse events developed in 10 cases (12.9%): 5 post-MiES delayed bleeding and 5 mild pancreatitis. MiES was clinically successful in 35 patients (72.9%) who did not experience any more episodes of AP. Improvement in quality of life (PGIC ≥6) occurred in 41/48 patients (85.4%). On multivariate analysis, stenosis of the MiES was the only predictive factor for increased risk of recurrent pancreatitis after initial therapy. Conclusion: MiES resulted an efficient treatment for ARP in patients with PD with clinical benefit, patient satisfaction and improved quality of life even at long-term follow-up.

Fully covered self-expandable metal stents to dilate persistent pancreatic strictures in chronic pancreatitis: long-term follow-up from a prospective study.

BACKGROUND AND AIMS: Symptomatic main pancreatic duct (MPD) strictures secondary to chronic pancreatitis (CP) may benefit from endoscopic insertion of single or multiple plastic stents. MPD stricture resolution after single plastic stent removal is uncommon. The use of removable fully covered, self-expandable metal stents (FC-SEMSs) to dilate MPD strictures secondary to CP was evaluated. METHODS: Patients with CP and symptomatic MPD stricture located in the head of the pancreas persisting for 3 months or more after placement of a single plastic stent were enrolled in a prospective single-arm trial. A nitinol FC-SEMS was inserted and removed after 6 months. The FC-SEMS diameter and length were chosen according to the stricture anatomy and MPD diameter above the stricture. Our primary objective was FC-SEMS removability. Secondary outcomes were MPD stricture resolution rate and adverse events. RESULTS: Between December 2012 and October 2014, 15 patients (10 male, mean age 60 years) were enrolled. Pancreatic calcifications were present in 6 (40%) patients. Four patients (27%) had a history of alcohol abuse. In 10 patients, the FC-SEMS was inserted through the major papilla, whereas 5 patients (3 pancreas divisum, 2 dominant dorsal duct) received the stent through the minor papilla. One patient developed cholangitis after 24 hours due to occlusion of the biliary sphincterotomy from the FC-SEMS; cholangitis resolved after insertion of a plastic biliary stent. Complete distal migration of the FC-SEMS was reported in 7 patients (47%) (5 asymptomatic, 2 symptomatic with recurrence of pancreatitis). All migrations occurred with the 3-cm-long FC-SEMS. Four patients (27%) developed de novo stricture induced by the FC-SEMS at the level of the flared end and were excluded from the follow-up; 1 patient with FC-SEMS migration had failed stricture resolution. One patient was lost to follow-up. Finally, 9 patients with MPD stricture resolution had a mean follow-up of 38.9 months (range, 5.3-55.3 months), and 89% were asymptomatic. CONCLUSIONS: FC-SEMS removability from the MPD in CP was feasible in all cases, and 90% of the patients were asymptomatic after 3 years. Migration seems more frequent with the 3-cm-long FC-SEMS. Occurrence of FC-SEMS-induced pancreatic strictures is a major issue and deserves further assessment. According to our experience, pancreatic FC-SEMSs have promising results, but a careful evaluation in the setting of clinical trials is needed.

Endoscopic treatment of post-laparoscopic sleeve gastrectomy leaks using a specifically designed metal stent.

Background and study aim Leakage of the surgical suture is the main complication of laparoscopic sleeve gastrectomy (LSG) and is amenable to endoscopic therapy. The aim of this study was to evaluate the efficacy of a specifically designed self-expandable metal stent (SEMS) to seal the leakage. Patients and methods Over a 2-year period, patients referred for the treatment of post-LSG fistulas underwent placement of a fully covered esophagogastric SEMS with a specific design. Results A total of 10 patients were treated after a mean time of 50.9 days from the diagnosis of post-LSG leakage. A total of 11 SEMSs were placed. After stent removal, the leakage was seen to have healed in eight patients. Two patients who were treated with an SEMS with different mesh design, experienced stent migration, which required alternative endoscopic treatment such as the insertion of double-pigtail stents. After a mean follow-up period of 13.4 months, all patients were asymptomatic. Conclusions: Placement of a specifically designed SEMS for the treatment of post-LSG fistulas seems a promising first-line therapy according to this small series.

ERCP in patients with prior Billroth II gastrectomy: report of 30 years' experience.

BACKGROUND AND STUDY AIM: Endoscopic retrograde cholangiopancreatography (ERCP) is difficult in patients with altered anatomy following Billroth II gastrectomy. Afferent loop intubation, selective cannulation, and sphincterotomy are the main issues. Experience from a tertiary referral endoscopy center is reported. PATIENTS AND METHODS: A total of 713 patients with Billroth II reconstruction who underwent ERCP between October 1982 and October 2012 were retrospectively identified from a prospectively collected database (mean age 69 ±â€Š27 years; 567 males). The main indications for ERCP were common bile duct stones (51.2 %) and obstructive jaundice (24.8 %). Procedures were always started with a duodenoscope; in cases of failure to reach the papilla the duodenoscope was changed to a gastroscope. Endoscopic sphincterotomy was performed using a long-nose sigmoid inverted sphincterotome. RESULTS: The successful duodenal intubation rate was 86.7 % (618/713 patients). The main reason for intubation failure was a long and angulated afferent loop. Successful cannulation/opacification of the desired biliopancreatic duct was 93.8 % (580/618). Biliary and/or pancreatic sphincterotomy were performed in 490 (84.5 %) and 23 (4.0 %) patients, respectively. The adverse event rate was 4.3 % (45/1050 procedures). Peritoneal perforation occurred in 1.8 % of the cases (19/1050 procedures) and always required immediate surgery. Two patients died after surgery (overall mortality 0.3 %). The other adverse events resolved following conservative management or endoscopic reintervention. CONCLUSIONS: In experienced centers, ERCP in Billroth II patients had morbidity and mortality rates that were comparable to patients with normal anatomy. The main reasons for failure were related to the inability to reach the papilla. Peritoneal perforation was the most common adverse event, and required a prompt surgical approach.

The evolution and current state of bariatric endoscopy in Western countries.

With the alarmingly increasing prevalence of obesity in the Western world, it has become necessary to provide more acceptable treatment options for patients with obesity. Minimally invasive endoscopic techniques are continuously evolving. Currently, metabolic and bariatric endoscopies encompass several different techniques that can offer significant weight loss and improvement in comorbidities with a favorable safety profile. Restrictive bariatric procedures include the use of intragastric balloons and gastric remodeling techniques with different suturing devices. Several studies have demonstrated the efficacy and safety of these techniques that are widely used in clinical practice. Small intestine-targeted metabolic endoscopy is an intriguing and rapidly evolving field of research, although it is not widespread in routine practice. These techniques include duodenal-jejunal bypass liners, duodenal mucosal resurfacing, and incisionless anastomoses. The aim of this review article is to provide a detailed update on the currently available bariatric endoscopy techniques in Western countries.