Background and study aims:Colonoscopy is associated with discomfort that requires intravenous sedation (IVS). The aim of this randomized controlled trial (RCT) was to explore the feasibility of virtual reality distraction (VRD) for colonoscopy using two primary endpoints: cecal intubation rate and the rate of rescue with IVS. Patients and methods:Patients scheduled for elective colonoscopy with IVS were randomized in a 2:1 ratio in favor of VRD, with rescue IVS by propofol if needed. VRD involved use of a device providing a visual and auditive experience similar to clinical hypnosis. Results:Ninety patients were included (VRD:60, IVS: 30). Cecal intubation rate was similar in both groups (92.8% for VRD vs 100% for IVS, P =0.3). The rate of rescue IVS in the VRD group was 63.6%. There was a decrease in median total dose of propofol per patient in the VRD group (1.15 mg/kg for VRD and 4.41 mg/kg for IVS, P <0.001) and in the subgroup of VRD patients who received IVS rescue (3.17 mg/kg for VRD and 4.41 mg/kg for IVS, P =0.003). The median level of pain was higher and the median level of comfort was lower in the VRD group (respectively 3 vs 0, P <0.001 and 7 vs 10, P <0.001). Conclusions:This RCT provides preliminary data to better understand the feasibility of VRD for colonoscopy. We have not identified differences in procedure outcomes compared with conventional IVS, but nevertheless, higher pain and lower comfort scores were reported.

OBJECTIVE:Hemin, a heme oxygenase 1 activator has shown efficacy in the prevention and treatment of acute pancreatitis in mouse models. We conducted a randomized controlled trial (RCT) to assess the protective effect of Hemin administration to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in patients at risk.METHODS:In this multicenter, multinational, placebo-controlled, double-blind RCT, we assigned patients at risk for PEP to receive a single intravenous dose of Hemin (4 mg/kg) or placebo immediately after ERCP. Patients were considered to be at risk on the basis of validated patient- and/or procedure-related risk factors. Neither rectal NSAIDs nor pancreatic stent insertion were allowed in randomized patients. The primary outcome was the incidence of PEP. Secondary outcomes included lipase elevation, mortality, safety, and length of stay.RESULTS:A total of 282 of the 294 randomized patients had complete follow-up. Groups were similar in terms of clinical, laboratory, and technical risk factors for PEP. PEP occurred in 16 of 142 patients (11.3%) in the Hemin group and in 20 of 140 patients (14.3%) in the placebo group (p = 0.48). Incidence of severe PEP reached 0.7% and 4.3% in the Hemin and placebo groups, respectively (p = 0.07). Significant lipase elevation after ERCP did not differ between groups. Length of hospital stay, mortality and severe adverse events rates were similar between groups.CONCLUSION:We failed to detect large improvements in PEP rate among participants at risk for PEP who received IV hemin immediately after the procedure compared to placebo.TRIAL REGISTRATION NUMBER:ClinicalTrials.gov number, NCT01855841).

RESULTS: All treatments except mechanical lithotripsy significantly outperformed sphincterotomy in terms of stone removal rate (risk ratio [RR], 1.03-1.29). SOC was superior to other adjunctive interventions (vs balloon sphincteroplasty [RR, 1.24; 95% CIs, 1.07-1.45], vs S+EPLBD [RR, 1.23; range, 1.06-1.42] and vs mechanical lithotripsy [RR, 1.34; range, 1.14-1.58]). Cholangioscopy ranked the highest in increasing the success rate of stone removal (surface under the cumulative ranking [SUCRA] score, 0.99) followed by S+EPLBD (SUCRA score, 0.68). SOC and S+EPLBD outperformed the other modalities when only studies reporting on stones greater than 15 mm were taken into consideration (SUCRA scores, 0.97 and 0.71, respectively). None of the assessed interventions was significantly different in terms of adverse event rate compared with endoscopic sphincterotomy or with other treatments. Post-ERCP pancreatitis and bleeding

Portobiliary fistulas are rare but may lead to life-threatening complications. Biliary plastic stent-induced portobiliary fistulas during endoscopic retrograde cholangiopancreatography have been described. Herein, we present a case of portal cavernography and recurrent hemobilia after endoscopic retrograde cholangiopancreatography in which a portobiliary fistula was detected in a patient with portal biliopathy. This likely indicates a change in clinical presentation (from bilhemia to hemobilia) after biliary drainage that was successfully treated by placement of a fully covered, self-expandable metallic stent.

Background and Aims: Bilomas most frequently result from postoperative bile leaks. The endoscopic conventional treatment is sphincterotomy +/- stent placement. In complex cases, such as altered anatomy or failure of conventional treatment, transpapillary/transfistulary (TP/TF) drainage or EUS-guided transmural drainage (EUS-TD) may obviate additional biliary surgery. This study reports our experience with treating biloma secondary to refractory biliary leak with TP/TF drainage or EUS-TD and evaluates the safety and outcomes associated with this approach. Methods: This observational study focused on consecutive patients managed for biliary leakage (diagnosis based on imaging and/or bile outflow from a surgical drain) at a tertiary care hospital (2007-2017). TP/TF drainage was performed by double-pigtail stent(s) placement to drain the biloma through the leak during ERCP. For EUS-TD, plastic stent(s) were placed under EUS control. Primary outcomes were a composite of clinical success (patient free of sepsis after percutaneous drain removal and, in patients with benign disease, removal of all endoscopically placed stents, without need for reintervention) and biloma regression (<3 cm) at last follow-up. Results: Thirty patients (men, 57%; median age, 55 years) were included. Most biliary leaks resulted from cholecystectomy (27%) and hepatectomy (50%). Initial EUS-TD and TP/TF drainage were performed in 14 (47%) and 16 (53%) patients, respectively. At last follow-up (median, 33.2 months), clinical success and primary outcome were achieved in 70.4% of patients (EUS-TD, 75%; TP/TF, 67%). Additional surgery was necessary in 1 patient. Rate of serious adverse events was 23% (7/30), of which 13% (4/30) were procedure related. There were 4 deaths during the course of treatment, 2 of which were related to endoscopic interventions (hemorrhage and fibrillation). Conclusions: TP/TF drainage or EUS-TD is technically feasible with high clinical success and may avoid the need for additional surgery in complex cases or in patients with altered anatomy.

ABSTRACT Background Post-laparoscopic fundoplication (LF) dysphagia occurs in 5%–17% of patients and optimal management remains a topic of expert discussion. We assessed the efficacy and safety of pneumatic dilation (PD) in patients with persistent post-lLF dysphagia. Methods Medical files of patients treated with PD for persistent post-fundoplication-associated dysphagia were reviewed. The primary outcome was long-term clinical success. Secondary endpoints were initial clinical success, dysphagia recurrence rate, and PD-related complication incidence. Results Overall, 46 patients (74% women, 57.9±11.9 years) underwent 74 PD (mean: 1.6±0.8). A 30 mm, 35 mm, and 40 mm balloon was used in 45.9%, 43.2%, and 10.8%, respectively, of dilations. Among 45 patients with available follow-up, the overall long-term success rate of PD was 31/45 (68.9% [55.4–82.4]). Initial clinical success was 36/45 (80% [68.3–91.7]). Dysphagia recurred in 9 patients (25%; 95%CI 10.9–39.1) and 4 of these were effectively treated with a new dilation. Among 14 non-responders to PD, 11 underwent surgery. Four complications (2 perforations, 1 muscularis dilaceration, and 1 peri-procedural bleeding) occurred in 4 patients (incidence: 5.4% [95%CI; 0.3–10.6]) and were treated with partially covered self-expandable esophageal stents andhemostatic clips. Conclusions Pneumatic balloon dilation for post-fundoplication-associated symptoms is associated with a satisfactory long-term success rate and acceptable safety profile.

Our laboratory has previously used NGF-differentiated PC12 cells as a sympathetic neuronal model to investigate the effects of NPY on catecholamine synthesis and release. We have additionally used these cells to demonstrate the NPY-induced inhibition of Ca2+ channels which was suggested by those studies. In the present work, multiple NPY, PYY, and PP analogs are utilized to further define the receptor subtypes involved in this Ca2+ channel modulation. We find that in PC12 cells NPY and PP modulate Ca2+ channels through Y1, Y2, Y3, and Y4 receptors. In addition, we show that these receptors are differentially coupled to N, L, and non-N, non-L Ca2+ channel subtypes. The results of the present study in combination with our previous investigations demonstrate an intriguing and complex role for NPY and PP in the modulation of sympathetic neurotransmission.

We report the case of a 68-year-old woman with a previous duodenal adenoma resection who underwent esophagogastroduodenoscopy, during which endoscopic biopsy of a hypertrophied minor duodenal papilla was performed with a standard biopsy forceps. The exam was otherwise normal and she was discharged with no pain or discomfort.

Blind positioning of a high-resolution manometry (HRM) probe across the esophagogastric junction (EGJ) is not always possible. We report our experience using guidewire-assisted water-perfused HRM probe insertion when the EGJ could not be traversed. Retrospective study analyzing the failure rate of EGJ insertion during HRM, and reporting a series of guidewire-assisted procedures. Among 2727 HRM procedures, the failure rate for traversing the EGJ was 2.7% (73 patients). The technique of guidewire-assisted placement of the HRM probe was used in 25 patients; it was well-tolerated and successful in all patients. No motility disorder was found in 6 patients. In four patients with previously diagnosed achalasia, achalasia subtype changed to type III in one patient. While a suspected motility disorder at barium esophagram and/or initial imperfect HRM tracing was confirmed in 10 patients, a new motility disorder was diagnosed in five patients using guidewire-assisted placement of the HRM probe. In cases of inability to traverse the EGJ, insertion of a water-perfused HRM probe using an endoscopically-placed nasogastric guidewire allows successful EGJ and esophageal peristalsis assessment. Although motility disorders are often suspected using alternative diagnostic modalities, guidewire-assisted placement of HRM may be helpful for revealing them in patients where alternative diagnostic modalities are either unavailable or inconclusive.

Background and study aims This was a single-blind, single-center, prospective randomized controlled trial aimed at comparing the efficacy of three different suture patterns for endoscopic sleeve gastroplasty using Endomina (E-ESG). Patients and methods The suture patterns aimed to modify gastric accommodation by increasing the fundus distention ability (Group A), to reduce gastric volume (Group B) or to interrupt gastric emptying (Group C). Patients were randomized 1:1:1 and underwent clinical follow-up, gastric emptying scintigraphy, and satiety tests at baseline and 6 and 12 months post-procedure. The primary outcome was total body weight loss (TBWL) and excess weight loss (EWL) at 12 months post-procedure. Secondary outcomes included the impact of the suture patterns on gastric emptying and satiety. Results Overall, 48 patients (40 [83.3 %] female, aged 41.9 ± 9.5 years, body mass indexI 33.8 ± 2.7 kg/m2) were randomized (16 in each group). In the entire cohort, mean (95 % confidence interval [CI]) TBWL and EWL at the end of the follow-up were 10.11 % (7.1–13.12) and 42.56 (28.23–56.9), respectively. There was no difference among the three study groups in terms of TBWL (95 %CI) (9.13 % [2.16–16.11] vs. 11.29 % [5.79–16.80] vs. 9.96 % [4.58–15.35]; P = 0.589) and EWL (95 %CI) (34.54 % [6.09–62.99] vs. 44.75 % [23.63–65.88] vs. 46.94 % [16.72–77.15]; P = 0.888) at 12 months post-procedure. The three groups did not differ in terms of mean gastric emptying time or in terms of satiety tests at the end of the follow-up. No serious adverse events occurred. Conclusions Three different suture patterns during E-ESG demonstrated comparable efficacy in terms of weight loss, with an overall EWL of > 25 % and TBWL of > 10 % at 12 months.

BACKGROUND AND AIMS:Candy cane syndrome (CCS) is an adverse event (AE) from gastrectomy or gastric bypass and end-to-side anastomosis to a jejunal loop. Preferential passage of food to the blind loop induces early satiety, pain, and regurgitation. An endoscopic device that combines 2 magnets and a self-retractable wire was designed to perform progressive septotomy with marsupialization. We evaluated the clinical safety and efficacy of this treatment in CCS. METHODS:Consecutive patients presenting with symptoms associated with CCS after gastrectomy or Roux-en-Y gastric bypass were treated with the MAGUS (Magnetic Gastrointestinal Universal Septotome) system. Weight, dysphagia, pain scores, 12-item Short Form Survey quality of life physical and mental scores, GERD Health-Related Quality of Life, and Eckardt score were measured at baseline and 1 and 3 months postprocedure. Satisfaction with therapy and AEs were monitored during follow-up. RESULTS:Fourteen consecutive patients with CCS were enrolled in the study. Thirteen MAGUS systems migrated within 28 days after achieving uneventful complete septotomy. In 1 patient the magnet had to be collected from the right-sided colon after 1 month. Treatment was completed in a single endoscopy session. Dysphagia score (2 [1-3] vs 1 [1-1], P = .02), pain score (7 [6-8] vs 1 [0-1], P = .002), Eckardt score (5 [3-8] vs 1 [0-2], P = .002), GERD Health-Related Quality of Life score (37 [29-45] vs 8 [6-23], P = .002), and quality of life physical and mental scores were all significantly improved at 3 months. No device or procedure-related serious AEs were observed. One patient died during follow-up from evolution of oncologic disease. CONCLUSIONS:Endoluminal septotomy using a retractable wire and magnet system in CCS is feasible and safe, with rapid improvement of symptoms. (Clinical trial registration number: NCT04480216.).

Main recommendations Malignant disease 1 ESGE recommends placement of partially or fully covered self-expandable metal stents (SEMSs) for palliation of malignant dysphagia over laser therapy, photodynamic therapy, and esophageal bypass. Strong recommendation, high quality evidence. 2 ESGE recommends brachytherapy as a valid alternative, alone or in addition to stenting, in esophageal cancer patients with malignant dysphagia and expected longer life expectancy. Strong recommendation, high quality evidence. 3 ESGE recommends esophageal SEMS placement for sealing malignant tracheoesophageal or bronchoesophageal fistulas. Strong recommendation, low quality evidence. 4 ESGE does not recommend SEMS placement as a bridge to surgery or before preoperative chemoradiotherapy because it is associated with a high incidence of adverse events. Other options such as feeding tube placement are preferable. Strong recommendation, low quality evidence. Benign disease 5 ESGE recommends against the use of SEMSs as first-line therapy for the management of benign esophageal strictures because of the potential for adverse events, the availability of alternative therapies, and their cost. Strong recommendation, low quality evidence. 6 ESGE suggests consideration of temporary placement of self-expandable stents for refractory benign esophageal strictures. Weak recommendation, moderate quality evidence. 7 ESGE suggests that fully covered SEMSs be preferred over partially covered SEMSs for the treatment of refractory benign esophageal strictures because of their very low risk of embedment and ease of removability. Weak recommendation, low quality evidence. 8 ESGE recommends the stent-in-stent technique to remove partially covered SEMSs that are embedded in the esophageal wall. Strong recommendation, low quality evidence. 9 ESGE recommends that temporary stent placement can be considered for the treatment of leaks, fistulas, and perforations. No specific type of stent can be recommended, and the duration of stenting should be individualized. Strong recommendation, low quality of evidence. 10 ESGE recommends considering placement of a fully covered large-diameter SEMS for the treatment of esophageal variceal bleeding refractory to medical, endoscopic, and/or radiological therapy, or as initial therapy for patients with massive bleeding. Strong recommendation, moderate quality evidence.

BACKGROUND:A medical device that allows simple and safe performance of an endoscopic septotomy could have several applications in the gastrointestinal (GI) tract. We have developed such a device by combining two magnets and a self-retractable wire to perform a progressive septotomy by compression of the tissues. We describe here the concept, preclinical studies, and first clinical use of the device for the treatment of symptomatic epiphrenic esophageal diverticulum (EED).METHODS:The MAGUS (MAgnetic Gastrointestinal Universal Septotome) device was designed based on previous knowledge of compression anastomosis and currently unmet needs. After initial design, the feasibility of the technique was tested on artificial septa in pigs. A clinical trial was then initiated to assess the feasibility and safety of the technique.RESULTS:Animal studies showed that the MAGUS can perform a complete septotomy at various levels of the GI tract. In two patients with a symptomatic EED, uneventful complete septotomy was observed within 28 and 39 days after the endoscopic procedure.CONCLUSIONS:This new system provides a way of performing endoluminal septotomy in a single procedure. It appears to be effective and safe for managing symptomatic EED. Further clinical applications where this type of remodeling of the GI tract could be beneficial are under investigation.

Post-sleeve gastrectomy (SG) stenoses occur in about 5% of cases. Hydrostatic dilation (HD) and pneumatic dilation (PD) have been proposed as treatments, but efficacy data remain scarce. Objective is to describe long-term efficacy and safety of HD and PD. This retrospective study in a referral endoscopy center included patients with symptomatic post-SG stenosis treated with endoscopic balloon dilation (EBD). Stenosis was defined as “organic” if luminal narrowing was evident, “functional” for a deformation, or “combined.” Endoscopic treatment consisted of ≥ 1 HD (15–20 mm) and/or ≥ 1 PD (30–35 mm). Initial success was defined as improvement of stenosis-related symptoms at 1 month and long-term success as persistence of improvement at last follow-up. Forty-four patients (73% women; mean age 45.5 ± 11 years; mean follow-up 26 ± 23 months) underwent EBD between 2013 and 2019. HD and PD were used in 15 (34%) and 29 (66%) patients, respectively, (mean dilation number: 1.8 ± 1.1). Post-SG stenoses were considered organic in 10 (23%), functional in 21 (48%), and combined in 13 (29%) patients. Initial success was achieved in 42 (96%) patients, while 35 (80%) patients had no symptom recurrence at last follow-up. Perforation occurred in one patient. HD was more frequently used in organic stenoses (8/10), while PD in functional and combined stenoses (18/21 and 9/13, respectively; p < 0.001). Rates of success did not differ by type of stenosis. Endoscopic dilation is an effective treatment for post-SG stenoses, providing long-term symptom relief. PD should be preferred in cases of functional stenoses, and HD used for organic stenoses.

Abstract Background Long-term transmural double-pigtail stent (DPS) placement is recommended for patients with disconnected pancreatic duct syndrome (DPDS) and peripancreatic fluid collections (peri-PFCs). The long-term safety and efficacy of indwelling DPSs were evaluated. Methods Medical files of patients treated with DPS for DPDS-associated peri-PFC and with a follow-up ≥ 48 months were reviewed. Early ( < 30 days) and late complications of DPS placement were evaluated and the primary endpoint, i. e., incidence of late complications per 100 patient-years of follow-up, was calculated. Short- and long-term success rates of endoscopic treatment and rate of peri-PFC recurrence were among secondary endpoints. Results From 2002 to 2014 we identified 116 patients, with mean (SD) follow-up of 80.6 (34.4) months. Among early complications (n = 20), 6 occurred peri-interventionally. Late complications (n = 17) were mainly pain due to DPS-induced ulcer or erosion (n = 10) and 14 of these were treated conservatively or by stent removal; 2 gastro-pancreatico-colo-cutaneous fistulas and 1 persisting bleed required surgical intervention. No DPS-related deaths were recorded. The incidence rate (95 %CI) of late complications was 2.18 (1.27–3.49) per 100 patient-years of follow-up. Short- and long-term success rates (with 95 %CI) of endoscopic treatment were 97.4 % (94.5 %–100 %) and 94 % (89.6 %–98.3 %), respectively. The peri-PFC recurrence rate was 28 % (20.1 %–35.9 %), and 92.3 % of these occurred within the first 2 years. Stent migration, chronic pancreatitis, and length of stent (> 6 cm) were independently associated with higher rates of peri-PFC recurrence. Conclusions Long-term transmural drainage with DPS is a safe and effective treatment for DPDS-associated peri-PFCs. However, about one quarter of peri-PFCs will recur.

Background and study aims Current data show that traditional training methods in endoscopic retrograde cholangiopancreatography (ERCP) fall short of producing competent trainees. We aimed to evaluate whether a novel approach to simulator-based training might improve the learning curve for novice endoscopists training in ERCP. Methods We conducted a multicenter, randomized controlled trial using a validated mechanical simulator (the Boškoski-Costamagna trainer). Trainees with no experience in ERCP received either standard cannulation training or motion training before undergoing standard cannulation training on the mechanical simulator. Trainees were timed and graded on their performance in selective cannulation of four different papilla configurations. Results Thirty-six trainees (16 in the motion training group, 20 in the standard group) performed 720 timed attempts at cannulating the bile duct on the simulator. Successful cannulation was achieved in 698 of 720 attempts (96.9 %), with no significant difference between the two study groups (P = 0.37). Trainees in the motion training group had significantly lower median cannulation times compared to the standard group (36 vs. 48 seconds, P = 0.001) and better technical performance on the first papilla type (P = 0.013). Conclusions Our findings suggest that motion training could be an innovative method aimed at accelerating the learning curve of novice trainees in the early phase of their training. Future studies are needed to establish its role in ERCP training programs.

A 44-year-old woman underwent sleeve gastrectomy, which was complicated by a leak. She was treated with two sessions of endoscopic internal drainage using plastic double-pigtail stents. Her clinical evolution was favorable, but four months after the initial stent placement, she became symptomatic, and a gastrobronchial fistula with the proximal end of the stents invading the diaphragm was diagnosed. She was treated with antibiotics, plastic stents were removed, and a partially covered metallic esophageal stent was placed. Eleven weeks later, the esophageal stent was removed with no evidence of fistula. Inappropriate stent size, position, stenting duration, and persistence of low-grade inflammation could explain the patient's symptoms and provide a mechanism for gradual muscle rupture and fistula formation. Although endoscopic internal drainage is usually safe and effective for the management of post-laparoscopic sleeve gastrectomy leaks, close clinical and radiological follow-up is mandatory.

Background and Aim The aim of this study is to describe the cholangiographic features and endoscopic management of biliary cast syndrome (BCS), a rare specific ischemic cholangiopathy following liver transplantation. Methods Patients with biliary complications were identified from prospectively collected database records of patients who underwent liver transplantation at the Erasme Hospital from January 2005 to December 2014. After excluding patients with hepatico-jejunostomy or no suspicion of stricture, cholangiograms obtained during endoscopic retrograde cholangiopancreatography (ERCP) and magnetic resonance imaging were systematically reviewed. Biliary complications were categorized as anastomotic (AS) and non-AS strictures, and patients with BCS were identified. Clinical, radiological, and endoscopic data were reviewed. Results Out of 311 liver transplantations, 14 cases were identified with BCS (4.5%) and treated with ERCP. Intraductal hyperintense signal on T1-weighted magnetic resonance and a "duct-in-a-duct" image were the most frequent features of BCS on magnetic resonance imaging. On initial ERCP, 57% of patients had no stricture. Complete cast extraction was achieved in 12/14, and one of these had cast recurrence. On follow-up, 85% of the patients developed biliary strictures that were treated with multiple plastic stents reaching 60% complete stricture resolution, but 40% of them had recurrence. After a median follow-up of 58 months, BCS patients had lower overall and graft survival (42.9% and 42.9%) compared with non-AS (68.8% and 56.3%) and AS (83.3% and 80.6%), respectively. Conclusions Particular magnetic resonance-cholangiographic and ERCP-cholangiographic features of BCS have been identified. Outcomes for BCS are characterized by high complete cast extraction rates, high incidence of secondary strictures, and poorer prognosis.

Background and study aims Lateral duodenal wall perforation by a migrated stent is a potential complication of biliary stenting. By systematic database revision, we identified a series of six patients with lateral duodenal wall perforation caused by a displaced plastic biliary stent that were treated with over-the-scope clip (OTSC) between January 1, 2014 and March 31, 2019. In this series, most cases were related to stenting of benign strictures with single or double stenting and with the use of stents longer than 12 cm. OTSC permitted perforation closure in all cases. Most patients had an excellent outcome and did not need any subsequent intervention. However, one patient, who presented with a more severe pneumoretroperitoneum on computed tomography scan, required laparotomy with peritoneal lavage and eventually died due to this complication. We conclude that endoscopic treatment of these perforations with OTSC could be an effective alternative to surgery in selected patients.