Efficacy, Feasibility, and Safety of the X-Tack Endoscopic HeliX Tacking System: A Multicenter Experience.

BACKGROUND AND AIMS: The application of endoscopic suturing has revolutionized defect closures. Conventional over-the-scope suturing necessitates removal of the scope, placement of the device, and reinsertion. A single channel, single sequence, through-the-scope suturing device has been developed to improve this process. This study aims to describe the efficacy, feasibility, and safety of a through-the-scope suturing device for gastrointestinal defect closure. METHODS: This was a retrospective multicenter study involving 9 centers of consecutive adult patients who underwent suturing using the X-Tack Endoscopic HeliX Tacking System (Apollo Endosurgery). The primary outcomes were technical success and long-term clinical success. Secondary outcomes included adverse events, recurrence, and reintervention rates. RESULTS: In all, 56 patients (mean age 53.8, 33 women) were included. Suturing indications included fistula repair (n=22), leak repair (n=7), polypectomy defect closure (n=12), peroral endoscopic myotomy (POEM) site closure (n=7), perforation repair (n=6), and ulcers (n=2). Patients were followed at a mean duration of 74 days. Overall technical and long-term clinical success rates were 92.9% and 75%, respectively. Both technical and clinical success rates were 100% for polypectomies, POEM-site closures, and ulcers. Success rates were lower for the repair of fistulas (95.5% technical, 54.5% clinical), leaks (57.1%, 28.6%), and perforations (100%, 66.7%). No immediate adverse events were noted. CONCLUSION: This novel, through-the-scope endoscopic suturing system, is a safe and feasible method to repair defects that are ≤3 cm. The efficacy of this device may be better suited for superficial defects as opposed to full-thickness defects. Larger defects will need more sutures and probably a double closure technique to provide a reinforcement layer.

Outcomes of Endoscopic Ultrasound-guided Fine Needle Biopsy Using a Novel Hydrostatic Stylet Tissue Acquisition Technique.

BACKGROUND: Endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) is frequently used to obtain core samples of solid lesions. Here, we describe and evaluate a novel hydrostatic stylet (HS) technique designed to optimize core sample acquisition, reporting diagnostic yield, efficacy, and safety relative to the conventional stylet slow-pull (SP) technique. METHODS: A novel HS technique was developed and validated retrospectively. Consecutive patients who underwent EUS-FNB with core biopsy of solid lesions through either the HS or SP technique between January 2020 and April 2022 were included. Exclusion criteria included cystic lesions, nonlesional liver biopsies, and specimens sent for cytologic analysis only. Patient and lesion characteristics, number of passes, sample adequacy, and adverse events were compared between the two techniques. RESULTS: A total of 272 patients were included with 138 in the HS group and 134 in the SP group. Lesion size and anatomic distribution were similar in both groups. Compared with the SP approach, the HS technique demonstrated significantly higher sample adequacy (97.8% vs 83.6%, P < 0.001), higher sensitivity (97.1% vs 89.7%, P = 0.03), and lower mean number of passes (1.2 vs 3.3, P < 0.001). Rates and severity of adverse events in the HS group were comparable to the SP group and existing literature. Similar associations were observed in pancreatic and nonpancreatic lesion subanalyses. CONCLUSIONS: The novel HS technique demonstrated excellent biopsy sample adequacy and diagnostic yield while requiring fewer passes to obtain diagnostic specimens compared with a conventional EUS-FNB approach. Further prospective evaluation is needed to confirm these pilot findings and optimize EUS-FNB acquisition techniques.

Preferred techniques for endoscopic ultrasound-guided gastroenterostomy: a survey of expert endosonographers.

Background and study aims Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) is an emerging procedure that lacks technical standardization with limited adoption beyond expert centers. We surveyed high-volume endosonographers about the technical aspects of EUS-GE to describe how the procedure is currently performed at expert centers and identify targets for standardization. Methods Invitations to complete an electronic survey were distributed to 21 expert EUS practitioners at 19 U.S. centers. Respondents were surveyed about technical aspects of EUS-GE, indications, efficacy, safety, and attitudes toward the procedure. Results All 21 (100%) invited expert endoscopists completed the survey. Nine (42.9%) reported performing >10 EUS-GEs in the last 12 months. About half (47.6%, 10/21) puncture the target loop prior to lumen-apposing metal stent (LAMS) introduction, most often to confirm the loop is jejunum. No respondents reported guidewire placement prior to LAMS introduction. Most (71.4%, 15/21) do not use a guidewire at any time, while 28.6% (6/21) reported wire placement after distal flange deployment to secure the tract during apposition. Eight (38.1%, 8/21) reported at least one major adverse event, most commonly intraperitoneal LAMS deployment (87.5%, 7/8). Factors most often reported as advantageous for EUS-GE over enteral stenting included lack of papilla interference (33.3%, 7/21) and decreased occlusion risk (23.8%, 5/21). Conclusions Significant variation in performance technique for EUS-GE exists among expert US endoscopists, which may hinder widespread adoption and contribute to inconsistencies in reported patient outcomes. The granularity provided by these survey results may identify areas to focus standardization efforts and guide future studies on developing an ideal EUS-GE protocol.

Acute worsening of gastric outlet obstruction following EUS-guided gastrojejunal bypass.

Video 1Presentation and treatment of an unusual acute worsening of gastric outlet obstruction following EUS-guided gastrojejunal bypass.

Clinical outcomes and learning curve for ERCP during advanced endoscopy training: a comparison of supine versus prone positioning.

BACKGROUND AND AIMS: No studies have evaluated trainees' outcomes when learning ERCP with patients in the supine and prone positions simultaneously. We aimed to assess whether patient position impacts procedural outcomes and learning curve. METHODS: We prospectively evaluated patients undergoing ERCP by a supervised advanced endoscopy trainee (AET) at a tertiary care center. Adult patients with native papillae were included. The AET was universally given 5 attempts per cannulation. Outcomes were evaluated quarterly. RESULTS: Successful cannulation was achieved in 44 supine (69%) and 17 prone (68%) patients (P = .95). Although mean time to reach the papilla was shorter in the supine patient position, time to biliary cannulation (7.8 vs 9.4 minutes, P = .53) and number of attempts were similar. A stepwise increase was seen in cannulation rates throughout the academic year (P < .01) and increased more in supine patients (P = .01). Procedure and total room times were shorter in supine patients. CONCLUSIONS: Shorter procedure and room turnover times and a comparable cannulation rate were found for supine versus prone ERCP.

Benefits of EUS-guided gastroenterostomy over surgical gastrojejunostomy in the palliation of malignant gastric outlet obstruction: a large multicenter experience.

BACKGROUND AND AIMS: Palliation of malignant gastric outlet obstruction (mGOO) allows resumption of peroral intake. Although surgical gastrojejunostomy (SGJ) provides durable relief, it may be associated with a higher morbidity, interfere with chemotherapy, and require an optimum nutritional status. EUS-guided gastroenterostomy (EUS-GE) has emerged as a minimally invasive alternative. We aimed to conduct the largest comparative series to date between EUS-GE and SGJ for mGOO. METHODS: This multicenter retrospective study included consecutive patients undergoing SGJ or EUS-GE at 6 centers. Primary outcomes included time to resumption of oral intake, length of stay (LOS), and mortality. Secondary outcomes included technical and clinical success, reintervention rates, adverse events (AEs), and resumption of chemotherapy. RESULTS: A total of 310 patients were included (EUS-GE, n = 187; SGJ, n = 123). EUS-GE exhibited significantly lower time to resumption of oral intake (1.40 vs 4.06 days, P < .001), at lower albumin levels (2.95 vs 3.33 g/dL, P < .001), and a shorter LOS (5.31 vs 8.54 days, P < .001) compared with SGJ; there was no difference in mortality (48.1% vs 50.4%, P = .78). Technical (97.9% and 100%) and clinical (94.1% vs 94.3%) success was similar in the EUS-GE and SGJ groups, respectively. EUS-GE had lower rates of AEs (13.4% vs 33.3%, P < .001) but higher reintervention rates (15.5% vs 1.63%, P < .001). EUS-GE patients exhibited significantly lower interval time to resumption of chemotherapy (16.6 vs 37.8 days, P < .001). Outcomes between the EUS-GE and laparoscopic (n = 46) surgical approach showed that EUS-GE had shorter interval time to initiation/resumption of oral intake (3.49 vs 1.46 days, P < .001), decreased LOS (9 vs 5.31 days, P < .001), and a lower rate of AEs (11.9% vs 17.9%, P = .003). CONCLUSIONS: This is the largest study to date showing that EUS-GE can be performed among nutritionally deficient patients without affecting the technical and clinical success compared with SGJ. EUS-GE is associated with fewer AEs while allowing earlier resumption of diet and chemotherapy.

EUS-guided liver biopsy using a novel hydrostatic stylet technique.

Video 1Hydrostatic stylet technique for the performance of EUS-guided liver biopsy.

A surprising culprit for delayed gastrointestinal bleeding after endoscopic ultrasound-guided cholecystoduodenostomy: the double-pigtail stent.

Endoscopic ultrasound-guided gallbladder drainage using a lumen-apposing metal stent has emerged as an accepted option for the treatment of acute cholecystitis in patients unfit for surgery. While metal stents carry a risk of intra- and post-procedural bleeding, the coaxial placement of a double-pigtail stents through lumen-apposing metal stents has been proposed to lower the bleeding risk by preventing tissue abrasion against the stent flanges. We present a case of an 83 year-old male who had previously undergone uncomplicated endoscopic ultrasound-guided cholecystoduodenostomy with this technique. Six months later, he presented with upper gastrointestinal bleeding due to a duodenal pressure ulcer from the coaxial 10-Fr double-pigtail stent originally employed to prevent such bleeding. The 10-Fr stent was replaced with two 7-Fr stents whose increased flexibility and distribution of pressure across multiple points of contact with the duodenal wall was theorized to reduce the likelihood of erosion or perforation. Following the procedure, the patient's clinical course improved significantly with complete resolution of his symptoms of choledocholithiasis and cholecystitis. While 10-Fr double-pigtail stents are generally preferred for this indication due to their stiffness that reduces out-migration, use of more flexible 7-Fr stents may be advisable in thin-walled structures such as the duodenum.

EUS-guided enterocolostomy with lumen-apposing metal stent for palliation of malignant small-bowel obstruction (with video).

BACKGROUND AND AIMS: Interventions for malignant small-bowel obstruction (SBO) may be limited by extent of peritoneal disease, rendering surgical or traditional endoscopic methods (ie, luminal stenting or decompressive gastrostomy) unfeasible. We demonstrated the novel use of EUS-guided lumen-apposing metal stent placement for enterocolonic bypass in patients with malignant SBO who were deemed high risk for surgery. METHODS: Across 3 tertiary U.S. centers, a retrospective series of consecutive patients underwent attempted EUS-guided enterocolostomy (EUS-EC) for palliation of acute SBO because of malignant causes. Technique and devices used were described, and patient demographics and outcome data were collected. RESULTS: Ten patients were included, of whom 9 (90.0%) were men, with a mean age of 64.5 ± 14.0 years and who were 1.5 ± 2.1 years postdiagnosis. Technical success was achieved in 8 of 10 patients (80.0%) and clinical success in 7 of 10 (70.0%), with a single major adverse event (10.0%) of aspiration. Median time until resumption of oral intake was 1.0 day (range, 0-8) after the procedure, with an interval to discharge home of 6.5 days and survival of 57.0 days. CONCLUSIONS: EUS-EC is a new alternative for palliation of acute SBO because of advanced malignant disease when conservative measures fail and other surgical or endoscopic options are not possible. Additional larger studies with longer duration of follow-up are needed to further define efficacy and safety of this approach.

Successful minimally invasive management of adverse events following EUS-guided gallbladder drainage in a suboptimal surgical patient.

Video 1Successful minimally invasive management of adverse events following EUS-guided gallbladder drainage in a suboptimal surgical patient.

Endoscopic ultrasound-guided ileosigmoidostomy using a lumen-apposing metal stent for palliation of malignant small-bowel obstruction.

Video 1Endoscopic ultrasound-guided ileosigmoidostomy for relief of small bowel obstruction.

Endoscopic full-thickness resection of polyps involving the appendiceal orifice: a multicenter international experience.

BACKGROUND: Endoscopic resection of lesions involving the appendiceal orifice remains a challenge. We aimed to report outcomes with the full-thickness resection device (FTRD) for the resection of appendiceal lesions and identify factors associated with the occurrence of appendicitis. METHODS: This was a retrospective study at 18 tertiary-care centers (USA 12, Canada 1, Europe 5) between November 2016 and August 2020. Consecutive patients who underwent resection of an appendiceal orifice lesion using the FTRD were included. The primary outcome was the rate of R0 resection in neoplastic lesions, defined as negative lateral and deep margins on post-resection histologic evaluation. Secondary outcomes included the rates of: technical success (en bloc resection), clinical success (technical success without need for further surgical intervention), post-resection appendicitis, and polyp recurrence. RESULTS: 66 patients (32 women; mean age 64) underwent resection of colonic lesions involving the appendiceal orifice (mean [standard deviation] size, 14.5 (6.2) mm), with 40 (61 %) being deep, extending into the appendiceal lumen. Technical success was achieved in 59/66 patients (89 %), of which, 56 were found to be neoplastic lesions on post-resection pathology. Clinical success was achieved in 53/66 (80 %). R0 resection was achieved in 52/56 (93 %). Of the 58 patients in whom EFTR was completed who had no prior history of appendectomy, appendicitis was reported in 10 (17 %), with six (60 %) requiring surgical appendectomy. Follow-up colonoscopy was completed in 41 patients, with evidence of recurrence in five (12 %). CONCLUSIONS: The FTRD is a promising non-surgical alternative for resecting appendiceal lesions, but appendicitis occurs in 1/6 cases.

Evaluation of diagnostic yield of EUS among patients with asymptomatic common bile duct dilation: systematic review and meta-analysis.

BACKGROUND AND AIMS: Common bile duct (CBD) dilation is a frequent indication for EUS. Among asymptomatic individuals, biliary dilation may not be clinically significant; however, EUS is often relied on for the exclusion of benign and malignant pathology that might require further intervention. The yield of EUS evaluation for this indication is not well characterized and has significant implications for health resource utilization because asymptomatic biliary dilation is prevalent. Through this systematic review, we sought to appraise the yield of EUS evaluation of asymptomatic patients with radiologic evidence of isolated CBD dilation. METHODS: A protocolled search (PROSPERO: CRD42020193428) extracted original studies from the Cochrane Library, Ovid Embase, Google Scholar, Ovid Medline, PubMed, Scopus, and Web of Science Core Collection that described diagnostic yield of EUS among asymptomatic patients with biliary dilation. Cumulative EUS diagnostic yield was calculated through meta-analysis of proportions using inverse variance methods and a random-effects model. RESULTS: Of 2616 studies, 8 delineated the EUS yield among 224 asymptomatic patients. The cumulative yield of EUS for any pathology was 11.2% (95% confidence interval [CI], 3.6%- 21.6%). The EUS yield for benign etiologies was 9.2% (95% CI, 1.1%-21.9%), of which choledocholithiasis comprised 3.4% (95% CI, 0%-11.2%) and malignant etiologies .5% (95% CI, 0%-3.4%) of cases. CONCLUSIONS: EUS in patients with asymptomatic CBD dilation does yield findings of choledocholithiasis and malignancy, albeit at low rates. A cost-effectiveness analysis is warranted to further guide clinical decision-making in this area.

Outcomes of a hybrid technique using EMR and endoscopic full-thickness resection for polyps not amenable to standard techniques (with video).

BACKGROUND AND AIMS: The full-thickness resection device (FTRD) offers a safe and effective approach for resection of complex colorectal lesions but is limited to lesions <2 cm in size. A hybrid approach-combining EMR with the FTRD-significantly expands the pool of lesions amenable to this technique; however, its safety and efficacy has not been well established. METHODS: We report a single-center retrospective study of consecutive patients who underwent full-thickness resection (FTR) of colorectal lesions, either with a standalone FTRD or a hybrid (EMR + FTRD) approach. Outcomes of technical success, clinical success (macroscopically complete resection), R0 resection, and adverse events (AEs) were evaluated. RESULTS: Sixty-nine FTR procedures (38 standalone FTR and 31 hybrid EMR + FTR) were performed on 65 patients. The most common indications were nonlifting polyp (43%) or suspected high-grade dysplasia or carcinoma (38%). Hybrid EMR + FTR permitted resection of significantly larger lesions (mean, 39 mm; range, 15-70 mm) compared with standalone FTR (mean, 17 mm; range, 7-25 mm; P < .01). Clinical success (91%), technical success (83%), and R0 resection (81%) rates did not differ between standalone and hybrid groups. Most patients (96%) were discharged home on the day of the procedure. Three AEs occurred, including 2 patients who developed acute appendicitis. CONCLUSIONS: A hybrid approach combining EMR and FTRD maintains safety and efficacy while permitting resection of significantly larger lesions than FTRD alone.