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.

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.

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.

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.

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.

Five-Year Outcomes of Endoscopic Sleeve Gastroplasty for the Treatment of Obesity.

BACKGROUND AND AIMS: The growing burden of obesity as a chronic disease necessitates a multifaceted approach to management. There has been an increase in the number of available endoscopic therapies for weight management with endoscopic sleeve gastroplasty (ESG) proving to be one of the best options. The long-term efficacy of ESG for management of obesity is not known. This study sought to assess the long-term safety and efficacy of ESG for treatment of obesity. METHODS: This was a prospective cohort study. Participants underwent ESG in a single academic center, and were prospectively enrolled. All procedures were performed by the same therapeutic endoscopist. Patients with a body mass index of >30 kg/m2 (or >27 with comorbidities), who underwent ESG from August 2013 to August 2019 for treatment of obesity were enrolled. Patients were followed for up to 5 years after their procedure. The primary outcome was weight loss at 5 years after the procedure (% total body weight loss, TBWL) RESULTS: 216 patients (68% female) with a mean age of 46±13 years, and mean BMI of 39±6 kg/m2 underwent ESG. Out of 216 patients, 203, 96, and 68 patients were eligible for a 1-, 3-, and 5-year follow up, with complete follow-up rates of 70%, 71%, and 82%, respectively. At 5 years, mean TBWL was 15.9% (95% CI, 11.7-20.5, p < .001) and 90 and 61% of patients maintained 5 and 10% TBWL, respectively. There was an overall rate of 1.3% moderate adverse events (AEs), without any severe or fatal AEs. CONCLUSIONS: Our results suggest that ESG is safe and effective for treatment of obesity, with durable long-term results for at least up to 5 years after the procedure. This procedure should be considered as a reliable option for treatment of obesity.

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.

Endoscopic ultrasound-guided gallbladder drainage as a rescue therapy for unresectable malignant biliary obstruction: a multicenter experience.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is often unsuccessful in patients with duodenal stenosis or malignant ampullary infiltration. While endoscopic ultrasound-guided biliary drainage (EUS-BD) has been proposed as an alternative, EUS-guided gallbladder drainage (EUS-GBD) is an attractive option when both approaches fail. We aimed to assess the effectiveness and safety of EUS-GBD as rescue therapy for malignant distal bile duct obstruction. METHODS: A multicenter retrospective study was performed on patients with unresectable malignant distal bile duct obstruction who underwent EUS-GBD between 2014 and 2019 after unsuccessful ERCP and EUS-BD. Clinical success was defined as a decrease in serum bilirubin of > 50 % within 2 weeks. RESULTS: 28 patients were included, with a lumen-apposing metal stent used in 26 (93 %) and a self-expandable metal stent in two (7 %). The technical success rate was 100 %. The clinical success rate was 93 %, with an improvement in bilirubin (7.3 [SD 5.4] pre-procedure vs. 2.8 [SD 1.1] post-procedure; P = 0.001). Delayed adverse events included food impaction of the stent (n = 3), with a further two patients developing cholecystitis and bleeding. CONCLUSION: This study demonstrates the feasibility of gallbladder drainage to relieve malignant distal bile duct obstruction in patients with failed ERCP and EUS-BD.

Characteristics and Outcomes of Patients Undergoing Endoscopy During the COVID-19 Pandemic: A Multicenter Study from New York City.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has significantly impacted the practice of endoscopy, but characteristics of COVID patients undergoing endoscopy have not been adequately described. AIMS: To compare findings, clinical outcomes, and patient characteristics of endoscopies performed during the pandemic in patients with and without COVID-19. METHODS: This was a retrospective multicenter study of adult endoscopies at six academic hospitals in New York between March 16 and April 30, 2020. Patient and procedure characteristics including age, sex, indication, findings, interventions, and outcomes were compared in patients testing positive, negative, or untested for COVID-19. RESULTS: Six hundred and five endoscopies were performed on 545 patients during the study period. There were 84 (13.9%), 255 (42.2%), and 266 (44.0%) procedures on COVID-positive, negative, and untested patients, respectively. COVID patients were more likely to undergo endoscopy for gastrointestinal bleeding or gastrostomy tube placement, and COVID patients with gastrointestinal bleeding more often required hemostatic interventions on multivariable logistic regression. COVID patients had increased length of stay, intensive care unit admission, and intubation rate. Twenty-seven of 521 patients (5.2%) with no or negative COVID testing prior to endoscopy later tested positive, a median of 13.5 days post-procedure. CONCLUSIONS: Endoscopies in COVID patients were more likely to require interventions, due either to more severe illness or a higher threshold to perform endoscopy. A significant number of patients endoscoped without testing were subsequently found to be COVID-positive. Gastroenterologists in areas affected by the pandemic must adapt to changing patterns of endoscopy practice and ensure pre-endoscopy COVID testing.

Prevalence of Celiac Disease in Patients With Iron Deficiency Anemia-A Systematic Review With Meta-analysis.

BACKGROUND & AIMS: Anemia is common in patients with celiac disease (CD) and a frequent mode of presentation. Guidelines recommend screening patients with iron-deficiency anemia (IDA) for CD. However, the reported prevalence of CD in patients with IDA varies. We performed a systematic review to determine the prevalence of biopsy-verified CD in patients with IDA. METHODS: We performed a systematic review of articles published in PubMed Medline or EMBASE through July 2017 for the term "celiac disease" combined with "anemia" or "iron deficiency." We used fixed-effects inverse variance-weighted models to measure the pooled prevalence of CD. Meta-regression was used to assess subgroup heterogeneity. RESULTS: We identified 18 studies composed of 2998 patients with IDA for inclusion in our analysis. Studies originated from the United Kingdom, United States, Italy, Turkey, Iran, and Israel. The crude unweighted prevalence of CD was 4.8% (n = 143). Using a weighted pooled analysis, we found a prevalence of biopsy-confirmed CD of 3.2% (95% confidence interval = 2.6-3.9) in patients with IDA. However, heterogeneity was high (I2 = 67.7%). The prevalence of CD was not significantly higher in studies with a mean participant age older or younger than 18 years or in studies with a mixed-sex vs female-predominant (≥60%) population. On meta-regression, year of publication, female proportion, age at CD testing, and prevalence in the general population were not associated with the prevalence of CD in patients with IDA. In the 8 studies fulfilling all our quality criteria, the pooled prevalence of CD was 5.5% (95% confidence interval = 4.1-6.9). CONCLUSIONS: In a systematic review and meta-analysis, we found that approximately 1 in 31 patients with IDA have histologic evidence of CD. This prevalence value justifies the practice of testing patients with IDA for CD.

Determinants of Patient Satisfaction in Celiac Disease Care.

BACKGROUND AND GOALS: There are little data examining patient satisfaction with celiac disease (CD) care. We sought to assess how satisfied patients are with their CD care, and to determine the influencing factors. STUDY: We distributed an online questionnaire to adults receiving programmatic updates from a CD referral center, querying aspects of CD care and using disease-specific validated instruments to measure quality of life and dietary adherence. The univariable and multivariable analyses were performed using satisfaction as a binary outcome comparing grouped "satisfied" and "very satisfied" respondents to "neutral," "dissatisfied," and "very dissatisfied" respondents. RESULTS: Three hundred eighty-seven (22%) individuals completed the survey, and 229 met the inclusion criteria of biopsy-proven CD. Seventy-nine individuals (34.5%) reported being "very satisfied" with their CD care, 82 (35.8%) "satisfied," 46 (20.1%) "neutral," 14 (6.1%) "dissatisfied," and 8 (3.5%) "very dissatisfied." On multivariable analysis, reporting that physicians spend ample time managing CD needs (P=0.013), and having CD-antibody levels checked yearly (P=0.003), were positive predictors of patient satisfaction. Factors that were not correlated with patient satisfaction included symptom severity (P=0.268), quality of life (P=0.13), and following with a CD specialist (P=0.139). CONCLUSIONS: The majority of patients we surveyed were satisfied with their CD care. We found that patients report higher satisfaction when they feel physicians spend time caring for their CD needs and when they receive annual CD-antibody testing. On the basis of our study, these factors are more important than disease severity, seeing a CD specialist, and quality of life in determining patient satisfaction with CD care.

Adenoma Detection is Increased in the Setting of Melanosis Coli.

GOALS: To compare the adenoma detection rate (ADR) during colonoscopy in patients with melanosis coli against matched controls without melanosis. BACKGROUND: Melanosis coli is a colonoscopic finding in which the colon wall appears darkly pigmented, most often due to extended laxative use, and is considered benign. The pigmentation spares adenomas, which should therefore be more readily detectable in melanosis coli. STUDY: We identified all patients with melanosis on colonoscopy at our institution over a 5-year period. We matched each patient with 2 controls by age, gender, and endoscopist. We compared the prevalence of adenomas between groups, and used multivariable analysis, adjusting for procedure indication and bowel preparation quality, to determine the independent association of melanosis with adenoma detection. RESULTS: At least 1 adenoma was detected in 34.7% of melanosis patients and 26.5% of controls [odds ratio (OR)=1.52; 95% confidence interval (CI), 1.04-2.24; P=0.03]. On multivariable analysis, the presence of melanosis remained associated with increased adenoma detection (OR=1.56; 95% CI, 1.05-2.33; P=0.03). Melanosis patients were more likely to have an adenoma ≤5 mm (OR=1.62; 95% CI, 1.04-2.51; P=0.03), but not adenomas 6 to 9 mm or ≥10 mm. CONCLUSIONS: Melanosis coli is associated with a significant increase in ADR during colonoscopy compared with controls. The increased visibility of adenomas given their contrast with the pigmented background is a likely explanation. Future efforts to identify bowel preparation agents that can induce a similar effect could improve ADRs during colonoscopy.

Endoscopic septotomy: an effective approach for internal drainage of sleeve gastrectomy-associated collections.

Background and study aims Staple-line leaks occur in 1 % - 7 % of patients who undergo sleeve gastrectomy, and can be challenging to treat. The success of endoscopic approaches decreases as leaks develop into chronic sinus tracts. Endoscopic septotomy has been used to facilitate healing of refractory leaks by incision and enlargement of the tract to allow direct communication with the gastric lumen and internal drainage. Patients and methods We reviewed the technique and outcomes among patients who underwent endoscopic septotomy at two centers for the management of sleeve gastrectomy-associated gastric fistulas and perigastric collections refractory to occlusive endoscopic therapies. Results Nine patients underwent endoscopic septotomy at a mean of 8.6 weeks after leak diagnosis, following failure of percutaneous and conventional endoscopic modalities. Perigastric collections ranged from 3 cm to 10 cm in size. The mean procedure time for endoscopic septotomy was 87.2 minutes. Multiple endoscopic septotomy procedures (mean 2.3, range 1 - 4) were required to achieve radiological resolution. The mean follow-up period was 21.2 weeks, and all nine patients achieved symptom resolution without the need for surgery. Bleeding at the time of endoscopic septotomy occurred in three patients, and was managed with endoscopic clips and did not require transfusion. No other adverse events or delayed complications were recorded. Conclusions Endoscopic septotomy appears to be a safe and effective technique for the management of sleeve gastrectomy-associated fistulae and collections, including those refractory to other endoscopic and percutaneous methods.