Storm, Andrew C.

Background Delayed bleeding is among the most common adverse events associated with endoscopic mucosal resection (EMR) of nonampullary duodenal polyps. We evaluated the rate of delayed bleeding and complete defect closure using a novel through-the-scope (TTS) suturing system for the closure of duodenal EMR defects. Methods We reviewed the electronic medical records of patients who underwent EMR for nonampullary duodenal polyps of ≥ 10 mm and prophylactic defect closure with TTS suturing between March 2021 and May 2022 at centers in the USA. We evaluated the rates of delayed bleeding and complete defect closure. Results 36 nonconsecutive patients (61 % women; mean [SD] age, 65 [12] years) underwent EMR of ≥ 10-mm duodenal polyps followed by attempted defect closure with TTS suturing. The mean (SD) lesion size was 29 (19) mm, defect size was 37 (25) mm; eight polyps (22 %) involved > 50 % of the lumen circumference. Complete closure was achieved in all cases (78 % with TTS suturing alone), using a median of one TTS suturing kit. There were no cases of delayed bleeding and no adverse events attributed to application of the TTS suturing device. Conclusion Prophylactic closure of nonampullary duodenal EMR defects using TTS suturing resulted in a high rate of complete closure and no delayed bleeding events.

Abstract Background and study aims The risk of bleeding with endoscopic ultrasound-guided tissue acquisition (EUS-TA) in patients on uninterrupted antithrombotic agents is unknown. This study aimed to assess the safety of EUS-TA without discontinuing direct oral anticoagulants. Methods Twenty pigs were randomized (1:1) to oral apixaban or placebo. Treatment was administered for 3 days before and 3 days after EUS-TA of the pancreas. Primary endpoint was occurrence of clinically significant bleeding events (CSBEs), defined as a composite outcome of drop in hemoglobin ≥ 2 g/dL and evidence of intraprocedural or post-procedure bleeding. Secondary outcome was cytopathological adequacy of acquired specimens. Endoscopists and pathologists were blinded to the treatment arm. Results Total of 80 tissue samples were obtained. CSBE occurred in one animal with apixaban levels above the upper limit (P = 1). Intraprocedural bleeding occurred in five animals (25 %), four of which from the apixaban group. Hematoma at necropsy was found in 10 animals (50 %), six of which were on apixaban. Median drop in hemoglobin was similar in both groups. Adequacy of specimens for cytology and pathology evaluation was confirmed in 20 of 20 and 19 of 20 animals, respectively. Conclusions In this pilot preclinical trial, EUS-TA under apixaban showed a trend toward higher minor bleeding events but did not increase CSBE or prevent adequate cytopathological evaluation.

Objective: To evaluate the safety and efficacy of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS). Background: For patients with acute cholecystitis who are poor surgical candidates, EUS-GBD using a LAMS is an important treatment alternative to percutaneous gallbladder drainage. Methods: We conducted a regulatory-compliant, prospective multicenter trial at 7 tertiary referral centers in the United States of America and Belgium. Thirty consecutive patients with mild or moderate acute cholecystitis who were not candidates for cholecystectomy were enrolled between September 2019 and August 2021. Eligible patients had a LAMS placed transmurally with 30 to 60-day indwell if removal was clinically indicated, and 30-day follow-up post-LAMS removal. Endpoints included days until acute cholecystitis resolution, reintervention rate, acute cholecystitis recurrence rate, and procedure-related adverse events (AEs). Results: Technical success was 93.3% (28/30) for LAMS placement and 100% for LAMS removal in 19 patients for whom removal was attempted. Five (16.7%) patients required reintervention. Mean time to acute cholecystitis resolution was 1.6±1.5 days. Acute cholecystitis symptoms recurred in 10.0% (3/30) after LAMS removal. Five (16.7%) patients died from unrelated causes. Procedure-related AEs were reported to the FDA in 30.0% (9/30) of patients, including one fatal event 21 days after LAMS removal; however, no AEs were causally related to the LAMS. Conclusions: For selected patients with acute cholecystitis who are at elevated surgical risk, EUS-GBD with LAMS is an alternative to percutaneous gallbladder drainage. It has high technical and clinical success, with low recurrence and an acceptable AE rate. Clinicaltrials.gov, Number: NCT03767881.

Abstract Background and study aims Gastric outlet obstruction (GOO) is traditionally managed with surgical gastroenterostomy (surgical-GE) and enteral stenting (ES). Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) is now a third option. Large studies assessing their relative risks and benefits with adequate follow-up are lacking. We conducted a comparative analysis of patients who underwent EUS-GE, ES, or surgical-GE for GOO. Patients and methods In this retrospective comparative cohort study, consecutive patients presenting with GOO who underwent EUS-GE, ES, or surgical-GE at two academic institutions were reviewed and independently cross-edited to ensure accurate reporting. The primary outcome was need for reintervention. Secondary outcomes were technical and clinical success, length of hospital stay (LOS), and adverse events (AEs). Results A total of 436 patients (232 EUS-GE, 131 ES, 73 surgical-GE) were included. The median duration of follow-up of the entire cohort was 185.5 days (interquartile range 55.25–454.25 days). The rate of reintervention in the EUS-GE group was lower than in the ES and surgical-GE groups (0.9 %, 12.2 %, and 13.7 %, P < 0.0001). Technical success was achieved in 98.3 %, 99.2 %, and 100 % (P = 0.58), and clinical success was achieved in 98.3 %, 91.6 %, and 90.4 % (P < 0.0001) in the EUS-GE, ES, and surgical-GE groups, respectively. The EUS-GE group had a shorter LOS (2 days vs. 3 days vs. 5 days, P < 0.0001) and a lower AE rate than the ES and surgical-GE groups (8.6 % vs. 38.9 % vs. 27.4 %, P < 0.0001). Conclusion This large cohort study demonstrates the safety and palliation durability of EUS-GE as an alternative strategy for GOO palliation in select patients.

Background Complete closure of large mucosal defects following colorectal endoscopic submucosal dissection (ESD) with through-the-scope (TTS) clips is oftentimes not possible. We aimed to report our early experience of using a novel TTS suturing system for the closure of large mucosal defects after colorectal ESD. Methods We performed a retrospective multicenter cohort study of consecutive patients who underwent attempted prophylactic defect closure using the TTS suturing system after colorectal ESD. The primary outcome was technical success in achieving complete defect closure, defined as a < 5 mm residual mucosal defect in the closure line using TTS suturing, with or without adjuvant TTS clips. Results 82 patients with a median defect size of 30 (interquartile range 25–40) mm were included. Technical success was achieved in 92.7 % (n = 76): TTS suturing only in 44 patients (53.7 %) and a combination of TTS suturing to approximate the widest segment followed by complete closure with TTS clips in 32 (39.0 %). Incomplete/partial closure, failure of appropriate TTS suture deployment, and the need for over-the-scope salvage closure methods were observed in 7.3 % (n = 6). One intraprocedural bleed, one delayed bleed, and three intraprocedural perforations were observed. There were no adverse events related to placement of the TTS suture. Conclusion The TTS suture system is an effective and safe tool for the closure of large mucosal defects after colorectal ESD and is an alternative when complete closure with TTS clips alone is not possible.

Objective Endoscopic sleeve gastroplasty (ESG) has gained global adoption but our understanding of its mechanism(s) of action and durability of efficacy is limited. We sought to determine changes in gastric emptying (GE), gastric motility (GM), hormones and eating behaviours after ESG. Design A priori-designed single-centre substudy of a large US randomised clinical trial, adults with obesity were randomised to ESG or lifestyle interventions (LS) alone. We measured GE, hormones and weight loss and assessed eating behaviours. In a subset of ESG patients, we assessed GM. The primary outcome was the change in T1/2 (min) at 3 months, and secondary outcomes were changes in weight, GE, GM, hormones and eating behaviours. We used t-test analyses and regression to determine the association between GE and weight loss. Results 36 (ESG=18; LS=18) participated in this substudy. Baseline characteristics were similar between the two groups. At 3 months, T1/2 was delayed in the ESG group (n=17) compared with the LS group (n=17) (152.3±47.3 vs 89.1±27.9; p<0.001). At 12 months, T1/2 remained delayed in the ESG group (n=16) vs control group (n=14) (137±37.4 vs 90.1±23.4; p<0.001). Greater delays in GE at 3 months were associated with greater weight loss. GM was preserved and fasting ghrelin, glucagon-like peptide 1 and polypeptide YY significantly increased 18 months after ESG. Conclusion ESG promotes weight loss through several key mechanistic pathways involving GE and hormones while preserving GM. These findings further support clinical adoption of this technique for the management of obesity. Trial registration number NCT03406975.

ABSTRACT A 19-year-old man diagnosed with diffuse large B-cell lymphoma undergoing chemotherapy presented for recurrent emesis and weight loss. Imaging studies of the abdomen demonstrated features of superior mesenteric artery syndrome. The patient deferred conservative treatment options and was deemed not to be a surgical candidate. Endoscopic ultrasound-guided gastroenterostomy using a lumen-apposing metal stent was performed to bypass the obstruction. Subsequently, the patient's oral intake and weight significantly improved. The stent was removed 6 months after placement with resolution of superior mesenteric artery syndrome symptoms.

Abstract Background and study aims Obtaining quality tissue during ERCP biliary stricture sampling is of paramount importance for a timely diagnosis. While single-operator cholangioscopy (SOC)-guided biopsies have been suggested to be the superior biliary tissue acquisition modality given direct tissue visualization, less is known about the specimen histological quality. We aimed to analyze the specimen quality of SOC biopsies and compare the new generation forceps with prior “legacy” forceps. Patients and methods Patients who underwent SOC from January 2017-August 2021 for biliary sampling were reviewed. In February 2020, the SOC-guided biopsy forceps were changed from legacy SpyBite to the SpyBite Max forceps (max). Specimens were assessed by blinded pathologists for crush artifact (none, mild, or severe) and gross size (greatest dimension in mm). Crush artifact and gross size were compared between the two groups. The diagnostic performance characteristics for cholangiocarcinoma (CCA), were assessed in an exploratory fashion. Results Eighty-one patients (max = 27, legacy = 54) with similar baseline characteristics were included in this study. On blinded pathological assessment, 58 % had crush artifact, without significant differences between the two groups (Max 63 % vs. Legacy 56 %; P = 0.64). A similar mean specimen size was found (max 3 mm vs. legacy 3.2 mm; P = 0.24). The overall prevalence of CCA was 40 %. The sensitivity, specificity, positive predictive value, and negative predictive value of the entire cohort using a combination of cytology, fluorescence in situ hybridization, and SOC-guided biopsies were 78.1 %, 91.8 %, 86.2 %, and 86.5 %, respectively. No difference between legacy or max groups was found. Conclusions A high rate of crush artifact was found in SOC-guided biopsy specimens. Further investigation regarding proper biopsy technique and handling is necessary to increase the diagnostic yield with SOC-guided biopsies.

AbstractObesity has been escalating as one of the worst public health epidemics. Conservative therapies including lifestyle modifications and weight loss medications have limited efficacy and long-term sustainability. Bariatric surgeries, although effective, remain underutilized due to their cost, safety concerns, and patient acceptance. In the past two decades, endoscopic bariatric and metabolic therapies (EBMTs) have emerged as safe, effective, and less invasive options for the treatment of obesity and its comorbidities, with recent studies reporting favorable outcomes in terms of weight loss and metabolic parameters. This article reviews the major and newly developed EBMTs, with emphasis on their metabolic effects and potential use in the management of metabolic conditions.

Abstract Background and study aims A percutaneous intragastric trocar (PIT) enables intraluminal use of laparoscopic tools and helps overcome traditional limitations of endoscopy. The aim of this study was to determine the efficacy of using a PIT to perform an anti-reflux stapling procedure. Materials and methods Trocars were placed in four animals and an articulating stapler was used to perform fundoplication under endoscopic guidance. Animals were monitored for 14 days post-procedure. Functional lumen imaging of the esophagogastric junction (EGJ) was performed at baseline, immediately post-intervention, and at 14 days. Results The procedure was successful in all animals who survived to day 14 without distress or significant adverse events. Baseline EGJ distensibility was 5.0 ± 1.2 mm2/mmHg, 2.7 ± 0.7 mm2/mmHg post-procedurally, and 3.0 ± 0.8mm2/mmHg on day 14. Average change in distensibility pre- and post-procedure was –2.3 ± 1.8 mm2/mmHg (95 % confidence interval [CI] –0.5 to 5.1, P = 0.08) while change in pre- and day 14 distensibility was –2.0 ± 1.4 mm2/mmHg (95 % CI –0.1 to 4.2, P = 0.06). Conclusions An intragastric trocar allows for use of large-diameter laparoscopic instruments to safely and effectively perform endoluminal fundoplication with anti-reflux properties that persist for at least 14 days.