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The introduction of new technologies in endoscopy has been met with uncertainty, skepticism, and lack of standardization or training parameters, particularly when disruptive devices or techniques are involved. The widespread availability of a novel endoscopic suturing device (OverStitch™) for tissue apposition has enabled the development of applications of endoscopic suturing.The American Gastroenterological Association partnered with Apollo Endosurgery to develop a registry to capture in a pragmatic non-randomized study the safety, effectiveness, and durability of endoscopic suturing in approximating tissue in the setting of bariatric revision and fixation of endoprosthetic devices.We highlight the challenges of the adoption of novel techniques by examining the process of developing and executing this multicenter registry to assess real-world use of this endoscopic suturing device. We also present our preliminary data on the safety and effectiveness of the novel device as it is applied in the treatment of obesity.The Prospective Registry for Trans-Orifice Endoscopic Suturing Applications (ES Registry) was an effective Phase 4, postmarketing registry aimed at capturing pragmatic, real-world use of a novel device. These findings serve to solidify the role of endoscopic suturing in clinical practice.

Background and Aims Direct endoscopic necrosectomy (DEN) of walled-off pancreatic necrosis (WOPN) lacks dedicated instruments and requires repetitive and cumbersome procedures. This study evaluated the safety and efficacy of a new powered endoscopic debridement (PED) system designed to simultaneously resect and remove solid debris within WOPN. Methods This was a single-arm, prospective, multicenter, international device trial conducted from November 2018 to August 2019 at 10 sites. Patients with WOPN ≥6 cm and ≤22 cm and with >30% solid debris were enrolled. The primary endpoint was safety through 21 days after the last DEN procedure. Efficacy outcomes included clearance of necrosis, procedural time, adequacy of debridement, number of procedures until resolution, hospital stay duration, and quality of life. Results Thirty patients (mean age, 55 years; 60% men) underwent DEN with no device-related adverse events. Of 30 patients, 15 (50%) achieved complete debridement in 1 session and 20 (67%) achieved complete debridement within 2 or fewer sessions. A median of 1.5 interventions (range, 1-7) were required. Median hospital stay was 10 days (interquartile range, 22). There was an overall reduction of 91% in percent necrosis within WOPN from baseline to follow-up and 85% in collection volume. Baseline WOPN volume was positively correlated with the total number of interventions (ρ = .363, P = .049). Conclusions The new PED system seems to be a safe and effective treatment tool for WOPN, resulting in fewer interventions and lower hospital duration when compared with published data on using conventional instruments. Randomized controlled trials comparing the PED system with conventional DEN are needed. (Clinical trial registration number: NCT03694210 .)

Background and study aims The rate of gastroesophageal reflux disease (GERD) after per oral endoscopic myotomy (POEM) is concerning. Endoscopic anti-reflux methods, such as Trans Oral Incisionless Fundoplication (TIF), are crucial for the long-term success of POEM, especially if they can be performed in the same session. Methods We completed a proof-of-concept canine pilot study (n = 6) to assess safety and feasibility of POEM and TIF in a single session (POEM-TIF). Subsequently, POEM-TIF was also performed in patients with achalasia (n = 5). Herein, we report on the safety, technical and clinical success of the first-in-human cases with symptom follow-up at 1, 3 and 6 months and pH testing at 6 months. Results POEM was completed successfully in six canines (3 anterior and 3 posterior myotomies), followed by TIF in the same session. Necropsy and extensive testing demonstrated no evidence of mucosal injury and no leaks. The reconstructed valve was 220 to 240 degrees, 3 to 4 cm in length, and resulted in concomitant esophageal lengthening (2–5 cm). Using similar principles, the first-in-human cases were performed without intraprocedural or delayed adverse events. pH testing at 6 months showed that four of five patients had no evidence of GERD (DeMeester > 14.72), and in one case, there was evidence of esophagitis. Conclusions Single session POEM-TIF appears to be safe and feasible. Early clinical human data suggests that it may be able to reduce post POEM GERD, however the additional secondary benefits such as lengthening and straightening of the esophagus, may prove to be equally important for the long-term success of POEM.

Gastric peroral endoscopic myotomy (G-POEM) has emerged as an effective management approach for patients with refractory gastroparesis. This study aims to comprehensively study the safety of G-POEM and describe the predictive factors of adverse events (AEs) occurrence.This study is a retrospective study involving 13 tertiary care centers (7 USA, 1 South America, 4 Europe, and 1 Asia). Patients who underwent G-POEM for refractory gastroparesis were included. Cases were identified by the occurrence of AEs. For each case, two controls were randomly selected and matched for age (± 10 years), gender, and etiology of gastroparesis.A total of 216 patients underwent G-POEM for gastroparesis. Overall, 31 (14%) AEs were encountered [mild 24 (77%), moderate 5 (16%), and severe 2 (6%)] during the duration of the study. The most common AE was abdominal pain (n = 16), followed by mucosotomy (n = 5) and capnoperitoneum (n = 4), and AEs were most commonly identified within the first 48-h post-procedure 18 (58%). The risk of adverse event occurrence was significantly higher for endoscopists with experience of 20 G-POEM procedures (OR 3.03 [1.03-8.94], p 0.05).G-POEM seems to be a safe intervention for refractory gastroparesis. AEs are most commonly mild and managed conservatively. Longitudinal mucosal incision, use of hook knife, use of clips for mucosal closure and endoscopist's experience with 20 G-POEM procedures is significantly associated with decreased incidence of AEs.

Minimally invasive endoscopic antireflux therapies are critical for bridging the gap between medical and surgical treatments for gastroesophageal reflux disease (GERD). Although multiple endoscopic devices have been developed, perhaps some of the most exciting options that are currently evolving are the full-thickness suturing techniques using widely available and low-cost platforms. Full-thickness endoscopic suturing can allow for a highly durable recreation of the anatomic and functional components of a lower esophageal sphincter, which are deficient in patients with GERD. Proper patient selection, endoscopic hiatal hernia evaluation, and standardized suturing methods are necessary to ensure success of endoscopic suturing for antireflux therapy.

Background Most studies on endoscopic ultrasound (EUS)-guided gastroenterostomy (EUS-GE) for palliation of malignant gastric outlet obstruction (GOO) utilized a 15-mm lumen-apposing metal stent (LAMS). More recently, a 20-mm LAMS has become available. This study aimed to compare rates of technical and clinical success and adverse events (AEs) in patients undergoing EUS-GE using a 20-mm vs. 15-mm LAMS. Methods Patients who underwent EUS-GE with 15-mm or 20-mm LAMS for malignant GOO during the period from January 2018 to October 2020 were included. The primary outcome was clinical success, defined as an increase in the gastric outlet obstruction score (GOOS) by at least 1 point during follow-up. Secondary outcomes were technical success, maximum tolerated diet, re-intervention rate, and rate/severity of AEs. Results 267 patients (mean age 67 years, 43 % women) with malignant GOO from 19 centers underwent EUS-GE. Clinical success rates were similar for the 15-mm and 20-mm stents (89.2 % [95 %CI 84.2 %–94.2 %] vs. 84.1 % [77.4%–90.6 %], respectively). However, a significantly higher proportion of patients in the 20-mm group tolerated a soft solid/complete diet at the end of follow-up (91.2 % [84.4 %–95.7 %] vs. 81.2 % [73.9 %–87.2 %], P = 0.04). Overall, AEs occurred in 33 patients (12.4 % [8.4 %–16.3 %]), with similar rates for 15-mm and 20-mm stents (12.8 % [7.5 %–18.2 %] vs. 11.8 % [6 %–17.6 %]), including incidence of severe/fatal AEs (2 % [0.4 %–5.8 %] vs. 3.4 % [0.9 %–8.4 %]). Conclusions The 20-mm and 15-mm LAMS show similar safety and efficacy for patients undergoing EUS-GE for malignant GOO. The 20-mm LAMS allows a more advanced diet and is, thus preferred for EUS-GE.

Backgrounds Endoscopic ultrasound (EUS)-guided placement of lumen-apposing metal stents (LAMSs) has gained popularity for the treatment of pancreatic walled-off necrosis (WON). We compared the 20-mm and 15-mm LAMSs for the treatment of symptomatic WON in terms of clinical success and adverse events. Methods We conducted a retrospective, case-matched study of 306 adults at 22 tertiary centers from 04/2014 to 10/2018. A total of 102 patients with symptomatic WON who underwent drainage with 20-mm LAMS (cases) and 204 patients who underwent drainage with 15-mm LAMS (controls) were matched by age, sex, and drainage approach. Conditional logistic regression analysis was performed to compare clinical success (resolution of WON on follow-up imaging without reintervention) and adverse events (according to American Society for Gastrointestinal Endoscopy criteria). Results Clinical success was achieved in 92.2 % of patients with 20-mm LAMS and 91.7 % of patients with 15-mm LAMS (odds ratio 0.92; P = 0.91). Patients with 20-mm LAMS underwent fewer direct endoscopic necrosectomy (DEN) sessions (mean 1.3 vs. 2.1; P Conclusions The 20-mm LAMS showed comparable clinical success and safety profile to the 15-mm LAMS, with the need for fewer DEN sessions for WON resolution.

Background Cryoballoon ablation could induce stricture formation to achieve outlet and pouch reduction in patients regaining weight after Roux-en-Y gastric bypass (RYGB). This pilot study aimed to assess technical feasibility and short-term efficacy. Methods A retrospective chart review (January – November 2018) at two academic centers identified patients with weight regain post-RYGB, treated with cryoablation if pouch > 4 cm and/or outlet > 15 mm. Patients were scheduled for surveillance endoscopies at 8 weeks. Results 22 patients presented 10.5 years (SD 4.42) post-RYGB with weight regain of 30.9 kg (SD 13.7). Technical success was 89.5 % for outlet ablation and 93.0 % for pouch ablation. From baseline to 8 weeks, the outlet was reduced from 24.1 mm (95 % confidence interval [CI] 19.8 to 28.5) to 17.1 mm (95 %CI 13.1 to 21.1; P Conclusion Cryoablation appears technically feasible and effective for outlet and/or pouch reduction in the short term.

Background and Aims The novel use of peroral endoscopic myotomy (POEM) in the treatment of Zenker’s diverticulum (ZD) was recently described in case reports. The aim of this study is to report a multicenter experience with the POEM technique in the management of ZD. Methods This is a multicenter international retrospective study involving 10 centers. The Zenker’s POEM technique was performed using principles of submucosal endoscopy. Results Seventy-five patients (73.3 ± 1.2 years, 33 women) were included with a mean Charleson comorbidity index of 4 ± .2. The mean size of ZD was 31.3 ± 1.6 mm (range, 10-89). The overall technical success rate was 97.3% (73/75). There were 2 technical failures because of the inability to locate the septum and failed tunnel creation. Adverse events occurred in 6.7% (5/75): 1 bleed (mild) conservatively managed and 4 perforations (1 severe, 3 moderate). The mean procedure time was 52.4 ± 2.9 minutes, and mean length of hospital stay was 1.8 ± .2 days. Clinical success was achieved in 92% (69/75) with a decrease in mean dysphagia score from 1.96 to .25 (P Conclusions Endoscopic management of ZD using the POEM technique is novel and feasible with promising efficacy and safety results. Long-term follow-up is needed to ensure durability of response. In addition, comparative studies with other treatment modalities are warranted.

Peroral endoscopic myotomy (POEM) offers an effective and a minimally invasive approach for the management of patients with achalasia and is now considered the standard of care at many centres around the world. Despite its excellent outcomes, the high incidence of postoperative GORD remains its major limitation. Unlike laparoscopic Heller myotomy (LHM), no concomitant fundoplication is performed during POEM, which can increase the incidence of GORD and its long-term consequences. Recently, we diagnosed a case of de novo Barrett’s oesophagus (BE) with oesophageal adenocarcinoma in a patient, 4 years after POEM was performed for achalasia, highlighting the possible long-term consequences of postprocedural GORD. Since it was first clinically described,1 POEM has gained worldwide acceptance as an endoscopic technique for the management of achalasia. Despite its well-established efficacy and safety, the development of GORD post-POEM remains a major concern.2 Of particular concern is that up to two-thirds of patients have asymptomatic and unrecognised GORD.3 The effectiveness of our current management and monitoring strategies for GORD following POEM is not well established. In addition, long-term data pertinent to chronic oesophageal acid exposure after POEM are lacking. The following case is of a 69-year-old man who initially presented at the age of 64 with a 15-year history of dysphagia, regurgitation, microaspiration and intermittent chest pain, and high-resolution oesophageal manometry (HREM) was consistent with type III achalasia. Impedance-pH study was negative for underlying gastro-oesophageal reflux (GER), and the patient had no additional pertinent medical, surgical or family history. POEM was performed with a 17 cm oesophageal myotomy and 2 cm gastric myotomy with no adverse events. Postprocedure, the distensibility index increased from a baseline value of 1.7 mm2/mm Hg to 6.3 mm2/mm Hg using the endoluminal functional lumen imaging probe (EndoFLIP), and oesophagram revealed proper lower oesophagus emptying with no …

Background and study aims There are conflicting data regarding the risk of post-ERCP pancreatitis (PEP) with self-expandable metallic stents (SEMS) compared to polyethylene stents (PS) in malignant biliary obstructions and limited data related to benign obstructions. Patients and methods A retrospective cohort study was performed of 1136 patients who underwent ERCP for biliary obstruction and received SEMS or PS at a tertiary-care medical center between January 2011 and October 2016. We evaluated the association between stent type (SEMS vs PS) and PEP in malignant and benign biliary obstructions. Results Among the 1136 patients included in our study, 399 had SEMS placed and 737 had PS placed. Patients with PS were more likely to have pancreatic duct cannulation, pancreatic duct stent placement, double guidewire technique, sphincterotomy and sphincteroplasty as compared to the SEMS group. On multivariate analysis, PEP rates were higher in the SEMS group (8.0 %) versus the PS group (4.8 %) (OR 2.27 [CI, 1.22, 4.24]) for all obstructions. For malignant obstructions, PEP rates were 7.8 % and 6.6 % for SEMS and plastic stents, respectively (OR 1.54 [CI, 0.72, 3.30]). For benign obstructions the PEP rate was higher in the SEMS group (8.8 %) compared to the PS group (4.2 %) (OR 3.67 [CI, 1.50, 8.97]). No significant differences between PEP severity were identified based on stent type when stratified based on benign and malignant. Conclusions PEP rates were higher when SEMS were used for benign obstruction as compared to PS. For malignant obstruction, no difference was identified in PEP rates with use of SEMS vs PS.

Background and Aims High rates of technical and clinical success were reported for lumen-apposing metal stent (LAMS) placement for peripancreatic fluid collection (PFC) drainage. However, data on the adverse event (AE) rates are heterogeneous. The aim of this study was to evaluate the incidence, severity, management, and risk factors of AEs related to the use of LAMSs for drainage of PFCs in a large cohort of patients. Methods This is a multicenter, international, retrospective review from 15 centers of all patients who underwent placement of LAMSs for the management of PFCs. A nested case-control study was conducted in patients with (case) or without (control) AEs. Results Three hundred thirty-three procedures in 328 patients were performed (5 patients treated with 2 LAMSs). Technical success was achieved in 321 patients (97.9%). Three hundred four patients were finally included in the study (7 excluded for lost to follow-up information; 10 excluded for deaths unrelated to LAMSs). The rate of clinical success was 89.5%. Seventy-nine LAMS-related AEs occurred in 74 of 304 patients (24.3%), after a mean time of 25.3 days (median, 18 days; interquartile range, 6-30) classified as 20 (25.3%) mild, 54 (68.4%) moderate, or 5 (6.3%) severe. On multivariable analysis compared with control subjects, cases were more likely to have walled-off necrosis (WON) versus pancreatic pseudocysts (odds ratio, 2.18; 95% confidence interval, 1.09-4.46; P = .028), whereas cases were less likely to have undergone tract (balloon) dilation (yes vs no; odds ratio, .47; 95% confidence interval, .22-.93; P = .034). Conclusions Data from this large international retrospective study confirm that the use of LAMSs for management of PFCs has excellent technical and good clinical success rates. The rate of AEs, however, is not negligible and should be carefully considered before using these stents for drainage of PFCs and in particular for WON. Further prospective studies are needed to confirm these findings. (Clinical trial registration number: NCT 03544008.)

Background and study aims Acute non-variceal upper gastrointestinal bleeding (UGIB) due to peptic ulcer disease (PUD) remains a common and challenging emergency managed by gastroenterologists. The proper role of endoscopic suturing on the management of PUD-related UGIB is unknown. Patients and methods This is an international case series of patients who underwent endoscopic suturing for bleeding PUD. Primary outcome was rate of immediate hemostasis and rate of early rebleeding (within 72 hours). Secondary outcomes included technical success, delayed rebleeding (> 72 hours), and rate of adverse events (AEs). Results Ten patients (mean age 66.7 years, 30 % female) were included in this study. Nine (90 %) had prior failed endoscopy hemostasis with an average of 1.4 ± 0.7 (range 1 – 3) prior endoscopic sessions. Forrest classification was Ib in 5 (50 %), IIa in 3 (30 %), IIb in 1(10 %), and IIc in 1 (10 %). Mean suturing time was 13.4 ± 5.6 (range 3.5 to 20) minutes. Technical success was 100 %. Rate of immediate hemostasis was 100 % and rate of early rebleeding was 0 %. Mean number of sutures was 1.5 (range, 1 – 4). No AEs were observed. Delayed recurrent bleeding was not observed in any cases after a median of 11 months (range 2 – 56), after endoscopic suturing. Conclusions Oversewing of a bleeding or high-risk ulcer using endoscopic suturing appears to be a safe and effective method for achieving endoscopic hemostasis. It may be considered as rescue endoscopic therapy when primary endoscopic hemostasis fails to control the bleeding or when hemorrhage recurs after successful control of bleeding.

Background and Aims Postsurgical fluid collections (PSFCs) are traditionally drained either percutaneously or surgically. Endoscopic drainage offers several advantages compared with either percutaneous or surgical approaches, including avoiding repeat surgery or the need to have a percutaneous drain in place for weeks. There are very little data regarding the use of lumen-apposing metal stents (LAMSs) in the drainage of PSFCs. We aim to study the technical and clinical success and adverse events (AEs) of using LAMSs in the drainage of PSFCs. Methods Collaborators from 8 centers retrospectively reviewed their endoscopic databases to find procedures using LAMSs for drainage of PSFCs. Technical success (successful placement of LAMSs into the fluid collection), clinical success (complete resolution of the fluid collection on repeat imaging or endoscopy), and intraprocedure and postprocedure AEs were measured. Results Forty-seven patients were identified with PSFCs after various surgeries. Thirteen patients had failed previous percutaneous or surgical drainage attempts. Fluid collections averaged 78.6 mm (range, 47-150 mm) in size. The most common site of stent placement was transgastric, followed by rectum and duodenum. Technical success rate was 93.6% and clinical success rate 89.3%. The intraprocedural AE rate was 4.25% and postprocedural AE rate 6.4%. There was 1 death unrelated to the procedure. Conclusions The use of LAMSs to drain PSFCs has a high technical and clinical success rate with low AEs. For collections that are favorably located adjacent to the stomach, duodenum, or rectum, LAMS placement is a viable alternative to repeat surgery or percutaneous drainage.

Background To assess the safety and efficacy of the Instinct clip in the acute endoscopic treatment of upper gastrointestinal bleeding (UGIB). Materials and methods This is the first large series reporting this clip in achieving hemostasis. A retrospective descriptive chart review was performed on patients presenting with recent overt GI bleeding treated with endoclip therapy at Mount Sinai Beth Israel Medical Center between May 2013 and January 2016. Results are expressed in absolute numbers, percentages, and trends. Results In total, 178 consecutive patients with UGIB were included. Source of bleeding was identified as duodenal ulcer (29.2%), gastric ulcer (22.5%), gastro-esophageal junction tear (8.4%), anastomosis (5.6%), erosive gastropathy (5.6%), Dieulafoy (5.1%), gastric polyp (4.5%), postendoscopic procedure (3.9%), angioectasia (3.4%), esophageal ulcer (2.8%), benign duodenal mass (2.8%), peg tube site (2.3%), gastric neoplasm (1.7%), esophagitis (1.1%), and small bowel ulcer (1.1%). Lesions demonstrated active bleeding in 47.5% (11.3% spurting and 36.2% oozing) and nonbleeding lesions in 52.5% (25.0% visible vessel, 11.9% hematin in ulcer base, 10.0% adherent clot, 5.6% flat spot). Initial hemostasis was achieved in 96.6%. Additional methods were used in 24.1% (argon plasma coagulation and epinephrine injection in 21.3%, surgery in 0.6%, and interventional radiology in 2.2%). There were no adverse events. In-hospital rebleeding was 7.3% and 3.9% presented with rebleeding within 30 days. Average procedure duration was 22.9 minutes and average length of hospital stay was 11.3 days. Conclusions The Instinct clip, when used for UGIB, seems to be safe and effective with similar rebleeding rates compared with other modalities.

Purpose of review Gastroparesis is a complex dysmotility disorder in which a number of normal gastric emptying mechanisms can be affected. The pylorus as an apparatus is particularly important since it stands as the last final gateway for gastric emptying. As such, pyloric interventions seem to be successful in reducing symptoms and also improving emptying of solids, an effect not observed with other medical interventions. Recent findings Gastric peroral endoscopic myotomy (G-POEM) is a novel technique which offers the promise of mimicking the success of a traditional surgical pyloroplasty, while embracing the minimally invasive paradigm of flexible endoscopic surgery. Emerging data seems to suggest that not only does G-POEM offer symptomatic and clinical improvement but also objective improvement in follow-up gastric emptying studies in as much as 70% of patients. Summary We believe that with proper patient selection, G-POEM will become a powerful tool for gastroenterologists managing this chronic debilitating disease.

Background and Aims EMR is the preferred endoscopic therapy for duodenal adenomas (DAs) but is associated with an overall adverse event rate of 26%. Cryotherapy using a Cryoballoon Focal Ablation System (CbFAS) can safely and effectively eradicate esophageal intestinal metaplasia. We report our first experience with cryoballoon ablation for treatment of flat DAs. Methods This was an American, multicenter, retrospective study involving 5 centers. DAs (Paris 0-IIa and 0-IIb) were treated with nitrous oxide for 5 to 12 seconds using CbFAS. Follow-up EGD was performed at 3 to 12 months. Results Seventeen DAs (mean size, 22.7 ± 14.3 mm; 12 tubular, 5 tubulovillous) from 13 patients (mean age, 66.5 ± 9.99 years; 61.5% males) were included in the study. Thirteen of 17 DAs (76.5%) had failed previous treatment, and 4 of 17 (23.5%) were treatment naIve. All procedures were technically successful and achieved a >50% decrease in size after cryoballoon ablation There was no increase in size or progression of disease for any lesions. Overall, treatment was completed in 15 of 17 patients, and recurrence-free survival was achieved in 12 of 17 (71%) after a median follow-up of 15.5 months (interquartile range [IQR], 6.8-19.4). The median cryoablation time per polyp was 4 minutes (IQR, 1-7.5 minutes), and the median total procedure time was 25 minutes (IQR, 22-30.5 minutes). There were no intra- or postprocedural adverse events. Conclusions Nitrous oxide cryoballoon ablation of nonpolypoid DAs is feasible, with promising safety and efficacy.

Background and study aims This is a case report on use of the CryoBalloon as a salvage technique for ablation of residual neoplasia at an endoscopic mucosal resection site. The site contained an embedded clip that could not be removed at two different sessions by three experienced endoscopists. On follow-up endoscopy, the clips and residual polyp no longer remained. The subtle scar that was present was biopsied and confirmed complete eradication of neoplasia and no polyp tissue. This case shows the potential of the CryoBalloon to ablate unwanted tissue outside of the esophagus.

Background and aims Rectal lesions traditionally represent the first lesions approached during endoscopic submucosal dissection (ESD) training in the West. We evaluated the safety and efficacy of rectal ESD in North America. Methods This is a multicenter retrospective analysis of rectal ESD between January 2010 and September 2018 in 15 centers. End points included: rates of en bloc resection, R0 resection, adverse events, comparison of pre- and post-ESD histology, and factors associated with failed resection. Results In total, 171 patients (median age 63 years; 56 % men) underwent rectal ESD (median size 43 mm). En bloc resection was achieved in 141 cases (82.5 %; 95 %CI 76.8–88.2), including 24 of 27 (88.9 %) with prior failed endoscopic mucosal resection (EMR). R0 resection rate was 74.9 % (95 %CI 68.4–81.4). Post-ESD bleeding and perforation occurred in 4 (2.3 %) and 7 (4.1 %), respectively. Covert submucosal invasive cancer (SMIC) was identified in 8.6 % of post-ESD specimens. There was one case (1/120; 0.8 %) of recurrence at a median follow-up of 31 weeks; IQR: 19–76 weeks). Older age and higher body mass index (BMI) were predictors of failed R0 resection, whereas submucosal fibrosis was associated with a higher likelihood of both failed en bloc and R0 resection. Conclusion Rectal ESD in North America is safe and is associated with high en bloc and R0 resection rates. The presence of submucosal fibrosis was the main predictor of failed en bloc and R0 resection. ESD can be considered for select rectal lesions, and serves not only to establish a definitive tissue diagnosis but also to provide curative resection for lesions with covert advanced disease.

Background and Aims EUS-guided biliary drainage (EUS-BD) has been used as a rescue procedure after failed endoscopic retrograde cholangiography (ERC), and there is growing interest in EUS-BD as a primary therapy for distal malignant biliary obstruction. After EUS-guided needle puncture of an obstructed bile duct, directional control of wire advancement remains an area of need, potentially addressed by a new steerable EUS access system. The aim of this study was to evaluate the safety and efficacy of this novel steerable access system in patients undergoing EUS-BD after failed ERC. Methods We performed a retrospective study of prospectively acquired data at 3 tertiary academic hospitals. Consecutive patients who had failed ERC followed by EUS-BD using the access device were included. Primary outcomes were safety and technical feasibility (successful completion of EUS-BD). Secondary outcomes were clinical success (75% improvement in liver function tests at 30 days) and device performance. Results Twenty-two consecutive patients underwent EUS-BD between October 10, 2018 and March 3, 2019. Needle puncture and selective wire advancement in the intended direction were both successful in 100% of cases (22/22). Technical success was 95% (21/22). Fifty-nine percent (13) underwent rendezvous, 32% (7) underwent choledochoduodenostomy, and 4.5% (1) underwent hepaticogastrostomy. One patient (4.5%) underwent percutaneous transhepatic cholangiography. There were no cases of wire shearing. The adverse event rate was 4.5% (mild pancreatitis in 1 patient). There was no bile leak, bleeding, or death at 30 days' follow-up. Conclusions This first clinical experience with a steerable access system for EUS-BD suggests it is safe and effective, particularly with regard to controlling direction of wire advancement.

Background and Aims Gastric per-oral endoscopic myotomy (G-POEM) recently has been reported as minimally invasive therapy for gastroparesis. The aims of this study were to report on the first multicenter experience with G-POEM and to assess the efficacy and safety of this novel procedure for patients with gastroparesis with symptoms refractory to medical therapy. Methods All patients with gastroparesis who underwent endoscopic pyloromyotomy (G-POEM) at 5 medical centers were included. Procedures were performed following the same principles as esophageal POEM. Clinical response was defined as improvement in gastroparetic symptoms with absence of recurrent hospitalization. Adverse events were graded according to the American Society for Gastrointestinal Endoscopy lexicon. Results A total of 30 patients with refractory gastroparesis (11 diabetic, 12 postsurgical, 7 idiopathic) underwent G-POEM. Previous therapies included Botox injection in 12, transpyloric stenting in 3, and PEG with jejunal extension (PEGJ) in 1. Nausea/vomiting were the predominant symptoms in 25 patients. Weight loss was present in 27 patients with an average of 10% loss of body weight. G-POEM was completed successfully in all 30 (100%) patients with a mean procedure time of 72 minutes (range, 35–223 min). The mean myotomy length was 2.6 ± 2.3 cm. The mean length of hospital stay was 3.3 days (range, 1–12 days). Two adverse events occurred in 2 (6.7%) patients, including 1 capnoperitoneum and 1 prepyloric ulcer, rated as mild and severe, respectively. Clinical response was observed in 26 (86%) patients during a median follow-up of 5.5 months. Four patients (2 diabetic, 1 postsurgical, 1 idiopathic cause) did not respond to G-POEM. Repeat gastric emptying scan was obtained in 17 patients, normalized in 8 (47%), and improved in 6 (35%) patients. Conclusion G-POEM is a technically feasible procedure. This small non-randomized study suggests the effectiveness of G-POEM for the treatment of patients with gastroparesis refractory to medical therapy. It concomitantly results in normalization of GES in a significant proportion of treated patients.

Background and Aims The need for transpapillary drainage (TPD) in patients undergoing transmural drainage (TMD) of pancreatic fluid collections (PFCs) remains unclear. The aims of this study were to compare treatment outcomes between patients with pancreatic pseudocysts undergoing TMD versus combined (TMD and TPD) drainage (CD) and to identify predictors of symptomatic and radiologic resolution. Methods This is a retrospective review of 375 consecutive patients with PFCs who underwent EUS-guided TMD from 2008 to 2014 at 15 academic centers in the United States. Main outcome measures included TMD and CD technical success, treatment outcomes (symptomatic and radiologic resolution) at follow-up, and predictors of treatment outcomes on logistic regression. Results A total of 375 patients underwent EUS-guided TMD of PFCs, of which 174 were pseudocysts. TMD alone was performed in 95 (55%) and CD in 79 (45%) pseudocysts. Technical success was as follows: TMD, 92 (97%) versus CD, 35 (44%) ( P = .0001). There was no difference in adverse events between the TMD (15%) and CD (14%) cohorts ( P = .23). Median long-term (LT) follow-up after transmural stent removal was 324 days (interquartile range, 72-493 days) for TMD and 201 days (interquartile range, 150-493 days) ( P = .37). There was no difference in LT symptomatic resolution (TMD, 69% vs CD, 62%; P = .61) or LT radiologic resolution (TMD, 71% vs CD, 67%; P = .79). TPD attempt was negatively associated with LT radiologic resolution of pseudocyst (odds ratio, 0.11; 95% confidence interval, 0.02-0.8; P = .03). Conclusions TPD has no benefit on treatment outcomes in patients undergoing EUS-guided TMD of pancreatic pseudocysts and negatively affects LT resolution of PFCs.

219 Background: Patients with locally advanced esophageal cancer can have progressive dysphagia and associated worsening quality of life (QOL). Maintenance of esophageal patency by reducing intraluminal tumor burden can improve QOL by palliating dysphagia and delay or prevent the need for feeding tubes and esophageal stents. We aimed to assess the effect of endoscopic palliative cryoablation with trūFreeze Spray Cryotherapy (SCT) on dysphagia burden, QOL, and survival in patients with esophageal cancer. Methods: This is a multi-center prospective study of esophageal cancer patients at 10 sites in the United States. Subjects are 18-89 years old with luminal esophageal cancer, non-surgical candidates, not receiving systemic therapy, without esophageal stents, or history of prior SCT for esophageal cancer. SCT is an endoluminal ablation modality using non-contact medical grade liquid nitrogen (LN2) reaching a temperature of -1960 C delivered by a catheter. SCT was performed at 6 week intervals or as clinically indicated at a dose of 2x30 or 3x30 seconds per every 2-3 cm treatment site. Dysphagia and QOL were assessed with the 5-point Dysphagia score and EORTC QLQ 30 and OES18 esophageal module. Results: Of 49 subjects, mean age is 74.2 ± 11.8, 88% are men, 92% have esophageal adenocarcinoma and 19% have prior esophageal surgery or esophagectomy. 75% had a history of chemotherapy and/or radiation, and 58% (n=21) had a tumor stage >2. Subjects had a total of 258 treatment sessions over a mean follow-up of 329.7 ± 219.1 days, and received a median of 4 (IQR:2-7) SCT sessions with an average dose of 90 (3x30 sec) seconds/treatment site. There were 19 procedure related adverse events (20.4% of patients and 7.4% of procedures), all of which were mild (n=13) or moderate (n=6) in severity. Mean baseline dysphagia score was 1.7 ± 0.9 and 89% maintained (72%) or improved (17%) their baseline dysphagia score after initial SCT, p

Peroral endoscopic myotomy (POEM) has emerged as a promising treatment option for achalasia and other foregut dysmotility disorders. However, much of the current postprocedural care, such as mandatory admission and routine esophagrams, has been adapted from current surgical practices and may not in fact be necessary. Here, we describe our algorithm and outcomes for same-day discharge.Outcomes of 103 consecutive patients who underwent POEM for achalasia and other foregut dysmotility disorders from January 2015 to December 2018 were analyzed. Patients were discharged on the same day without esophagrams following a predetermined algorithm based on procedural adverse events and postprocedural pain. Patients were closely monitored after discharge for adverse events at 24 and 48 hours and then routinely in the office setting.Of the 103 POEMs, 101 were completed successfully. A total of 62.4% of patients were discharged safely on the same day, 29.7% were admitted for mild pain, and 7.9% were admitted for observation for other reasons. Overall, there were no serious adverse events at any time point. Univariate analysis identified duration of disease greater than 3 years, longer length of procedure (50.9 vs 68.5 min, P .0001), and longer length of myotomy (7.2 vs 8.5 cm, P .0068) as significant factors associated with postprocedural pain requiring admission.Although same-day discharge and foregoing routine esophagram have been suggested by many, this routine has not been systematically implemented. This series suggests that an algorithm for same-day discharge based on postprocedure chest pain and procedural complexity is both safe and feasible.

BACKGROUND: Endoscopic mucosal resection of large non-pedunculated colon polyps is challenging. OBJECTIVE: To determine if the time of day or daily endoscopic workload play a role in outcomes of endoscopic mucosal resection for large non-pedunculated colon polyps greater than 20 mm. METHODS: This is a retrospective study of patients who underwent endoscopic mucosal resection of large non-pedunculated colon polyps. The time of day and endoscopic workload were compared across the following outcomes: the rate of complete resection of the polyp, the rate of referral for surgery, and the rate of residual neoplasia on follow-up. RESULTS: One hundred and three endoscopic mucosal resection procedures were performed. There were no differences in the rates of complete resection (80.8% vs. 70.0%; P = 0.25), the need for surgery (27.4% vs. 33.3%; P = 0.55), and rate of residual neoplasia (24.5% vs. 50.0%; P = 0.07) when comparing the time of day. Colon polyps greater than 40 mm were less likely to be completely resected versus polyps sized 20–39 mm (56.8% vs. 91.9%; P

Background and study aims Current endoscopic therapies for gastroesophageal reflux disorder (GERD) are limited by technical complexity, and/or cost. We sought to evaluate the success of a novel resection and plication (RAP) anti-reflux procedure. Patients and methods RAP was performed on 10 patients with GERD refractory to proton pump inhibitor (PPI) therapy. RAP consists of semi-circumferential mucosectomy along with full-thickness plication of the lower esophageal sphincter (LES) and cardia. We assessed the technical success and safety as well as followed GERD-Health Related Quality of Life (GERD-HRQL) scores and medication usage. Results All patients underwent RAP without adverse events and were discharged on the same day. Only half of the patients required general anesthesia. Follow-up ranged from 5 to 24 months (median 9 months) and all patients had a significant improvement in their GERD-HRQL scores (P Conclusions The RAP method has potential as an effective anti-reflux option. Its main advantages include a short procedure time, simple approach using readily available equipment, and possible avoidance of general anesthesia.

Peroral endoscopic myotomy (POEM) is an advanced endoscopic procedure classically performed for the treatment of achalasia. The procedure is based on principles of submucosal endoscopy and is composed of a mucosal incision, submucosal tunneling, myotomy, and mucosal closure. Multiple published studies that collectively include more than 6000 patients reported clinical success in more than 80% to 90% of patients. Recent literature also suggested durability of response over a medium-term follow-up. POEM is associated with a low rate of adverse events when performed by experienced operators. Gastroesophageal reflux is not infrequent after POEM but does not seem significantly different from reflux that occurs after Heller myotomy. POEM also seems to be effective in the treatment of spastic esophageal disorders (eg, jackhammer and diffuse esophageal spasm). Last, the role of gastric POEM (G-POEM) in the treatment of gastroparesis has been investigated in recent studies with promising results.

400 Background: Progressive dysphagia in locally advanced esophageal cancer worsens quality of life (QOL). Endoscopic cryoablation may effectively palliate dysphagia. Aim: To study the effect of palliative cryoablation with trūFreeze Spray Cryotherapy (SCT) in patients with esophageal cancer. Methods: This is an interim analysis of a multi-center prospective study of esophageal cancer patients who are non-surgical candidates, not on active systemic therapy, without esophageal stents, or prior SCT. SCT is an endoscopic ablation modality using liquid nitrogen (LN2) delivered by catheter. SCT occurred at 6 week intervals or as indicated at a dose of 2x30 or 3x30 secs/treatment site. Dysphagia and esophageal symptoms were assessed at baseline and after treatment with a 5-point Dysphagia score and the EORTC-QLQ-OES18 (higher score = more symptoms). Results: 39 subjects (mean age 74.4 ±12.2; 87% men, Table) had 182 treatment sessions over a mean follow-up of 206.9 days, and received a median 3 SCT sessions with an average dose of 90 (3x30) secs/site. There was 1 procedure related SAE (2.6% of patients and 0.5% procedures). Mean follow-up dysphagia score was 1.6 ±0.8 and 90% had same or improved dysphagia score after SCT treatment, p6 month follow-up. Clinical trial information: NCT03243734. [Table: see text]

Background & Aims Endoscopic ultrasound–guided transmural drainage and necrosectomy have become the standard treatment for patients with pancreatic walled-off necrosis (WON). Lumen-apposing metal stents (LAMS) have shown success in the management of pancreatic fluid collections. However, there are few data on their specific roles in management of WON. We investigated the efficacy and safety of LAMS in treatment of WON. Methods We performed a retrospective multicenter case series of 124 patients with WON who underwent endoscopic transmural drainage by using LAMS at 17 tertiary care centers from January 2014 through May 2015. Patients underwent endoscopic ultrasound–guided cystogastrostomy or cystoenterostomy with placement of an LAMS into the WON collection. At the discretion of the endoscopist, we performed direct endoscopic necrosectomy, irrigation with hydrogen peroxide, and/or nasocystic drain placement. We performed endoscopic retrograde cholangiopancreatography with pancreatic duct stent placement when indicated. Concomitant therapies included direct endoscopic debridement (n = 78), pancreatic duct stent placement for leak (n = 19), hydrogen peroxide–assisted necrosectomy (n = 38), and nasocystic irrigation (n = 22). We collected data for a median time of 4 months (range, 1–34 months) after the LAMS placement. The primary outcomes were rates of technical success (successful placement of the LAMS), clinical success (resolution of WON, on the basis of image analysis, without need for further intervention via surgery or interventional radiology), and adverse events. Results The median size of the WON was 9.5 cm (range, 4–30 cm). Eight patients had 2 LAMS placed for multiport access, all with technical success (100%). Clinical success was achieved in 107 patients (86.3%) after 3 months of follow-up. Thirteen patients required a percutaneous drain, and 3 required a surgical intervention to manage their WON. The stents remained patent in 94% of patients (117 of 124) and migrated in 5.6% of patients (7 of 124). The median number of endoscopic interventions was 2 (range, 1–9 interventions). Conclusions On the basis of a retrospective analysis of 124 patients, endoscopic therapy of WON by using LAMS is safe and effective. Creation of a large and sustained cystogastrostomy or cystoenterostomy tract is effective in the drainage and treatment of WON.