Comparing a 19-gauge fine-needle biopsy needle with a 22-gauge fine-needle biopsy needle for EUS-guided liver biopsy sampling: a prospective randomized study.

BACKGROUND AND AIMS: EUS-guided liver biopsy (EUS-LB) sampling is being increasingly used. We performed a prospective randomized trial to compare specimen adequacy of a 19-gauge fine-needle biopsy (FNB) needle with a 22-gauge FNB Franseen tip needle for EUS-LB sampling. METHODS: Forty-two consecutive patients referred for EUS-LB sampling were prospectively randomized to a 19-gauge or 22-gauge FNB needle. When the specimen with the 22-gauge needle was macroscopically inadequate, an additional pass with the 19-gauge needle was done. Bilobar EUS-LB sampling was performed with heparinized wet suction using 1 pass and 3 actuations per lobe. Descriptive statistics were computed for all variables. RESULTS: Biopsy sampling was performed for abnormal liver enzymes in 95.5% of patients (57% women; average age, 51 years). Five patients undergoing sampling with the 22-gauge FNB needle had macroscopically inadequate specimens and required additional biopsy sampling with the 19-gauge FNB needle. Mean preprocessing length of the longest tissue core was 21.5 ± 6.3 mm with a 19-gauge FNB needle compared with 9.4 ± 5.5 mm with the 22-gauge FNB needle (P < .001). Postprocessing specimens were significantly longer with 19-gauge than with 22-gauge FNB needles (17.4 mm vs 6.8, P < .001). There were no adverse events, and postprocedure pain and discomfort was similar in both groups (14% for 19-gauge vs 10% for 22-gauge, P = .99). CONCLUSIONS: Liver core biopsy sampling using the 19-gauge FNB needle is superior to the 22-gauge FNB needle in terms of length of longest core and aggregate specimen length. Considerably more fragmentation of the 22-gauge cores occurs during tissue processing. No increased postprocedure pain or AEs were found with the 19-gauge needle. A 19-gauge FNB needle is preferred to the 22-gauge FNB needle for EUS-LB. (Clinical trial registration number: NCT04806607.).

Effects of Glucagon-like Peptide-1 Receptor Agonists on Upper Endoscopy in Diabetic and Non-Diabetic Patients.

BACKGROUND AND AIMS: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) promote weight loss by suppressing appetite, enhancing satiety, regulating glucose metabolism and delaying gastric motility. We sought to determine whether GLP-1 RA use could impact sedated medical procedures like esophagogastroduodenoscopy (EGD). METHODS: We conducted a retrospective study on 35,183 patients who underwent EGD between 2019 and 2023, 922 of which were using a GLP-1-RA. Data were collected regarding demographics, diabetes status, retained gastric contents during EGD (RGC), incidence of aborted EGD, and necessity for repeat EGD. RESULTS: GLP-1 RA use was associated with a fourfold increase in the retention of gastric contents (p<0.0001), fourfold higher rates of aborted EGD (p<0.0001), and twice the likelihood of requiring repeat EGD (p=0.0001), even after stratifying for presence of diabetes. CONCLUSIONS: GLP-1 RA use can lead to delayed gastric emptying, affecting EGD adequacy regardless of the presence of diabetes, and may warrant dose adjustment to improve safety and efficacy of these procedures.

Safety, Efficacy and Clinical Utility of the 5.1mm EndoRotor Powered Debridement Catheter for Treatment of Walled-Off Pancreatic Necrosis.

BACKGROUND AND AIMS: Direct endoscopic necrosectomy (DEN) is a recommended strategy for treatment of walled-off-necrosis (WON). DEN uses a variety of devices including the EndoRotor (Interscope, Inc.) debridement catheter. Recently, a 5.1 mm EndoRotor with increased chamber size and rate of tissue removal was introduced. The aim of this study was to assess the efficacy and safety of this device. METHODS: A multi-center cohort study was conducted at eight institutions including patients who underwent DEN with the 5.1 mm EndoRotor. The primary outcome was the number of DEN sessions needed for WON resolution. Secondary outcomes included the average percent reduction in solid WON debris and decrease in WON area per session, total time spent performing EndoRotor therapy for WON resolution, and adverse events. RESULTS: 64 procedures in 41 patients were included. For patients in which the 5.1 mm EndoRotor catheter was the sole therapeutic modality, an average of 1.6 DEN sessions resulted in WON resolution with an average cumulative time of 85.5 minutes. Of the 21 procedures with data regarding percent of solid debris, the average reduction was 85% +/- 23% per session. Of the 19 procedures with data regarding WON area, the mean area significantly decreased from 97.6 +/- 72.0 cm2 to 27.1 +/- 35.5 cm2 (p<0.001) per session. Adverse events included two intra-procedural LAMS dislodgements managed endoscopically and three perforations none of which were related to EndoRotor. Bleeding was reported in seven cases, none required embolic or surgical therapy and two required blood transfusions. CONCLUSIONS: This is the first multi-center retrospective study to investigate the efficacy and safety of the 5.1 mm EndoRotor catheter for WON. Results from this study showed an average of 1.6 DEN sessions were needed to achieve WON resolution with an 85% single session reduction in solid debris and a 70% single session decrease in WON area with minimal adverse events.

Endoscopic powered resection device for residual colonic lesions: the first multicenter, prospective, international clinical study.

BACKGROUND AND AIMS: Endoscopic resection is standard treatment for adenomatous colorectal lesions. Depending on lesion morphology and resection technique, recurrence can occur. Scarred adenomas are challenging to resect and may require surgical management. This study evaluated the safety and effectiveness of an endoscopic powered resection (EPR) system for scarred adenomatous colorectal lesions. METHODS: This single-arm, prospective, multicenter study was conducted from January 2018 to January 2021 at 12 sites. Patients with persistent flat or sessile colorectal lesions were enrolled. Primary end points were technical success (the ability of the device to resect the lesion[s] without use of other resection devices without device-related serious adverse events [AEs]) and safety (the occurrence of AEs through 90 days). Secondary end points included endoscopic confirmation of resection completeness, occurrence of colon stenosis, disease persistence, and diagnostic value of resected specimens. RESULTS: Sixty-five patients were in the intention-to-treat/safety analysis population. Primary analysis was performed on 45 per-protocol (PP) patients with 48 lesions. All PP patients were solely treated by using the EPR device. Technical success was achieved in 44 (98%) patients. Three (5%) serious AEs occurred: 2 delayed self-limited bleeds and 1 perforation. Nonserious AEs included 4 (6%) cases of mild intraprocedural bleeding. Completeness of resection and histopathologic diagnosis of tissue specimens were achieved in all patients. Twenty-one (46.7%) patients had disease persistence after the first treatment, and there was no colon stenosis. CONCLUSIONS: EPR is safe and effective for benign, persistent, large (>20 mm), scarred colorectal adenomas and should be considered as an alternative treatment in lieu of surgery. A persistence rate of 46.7% indicates that >1 treatment is necessary for effective endoscopic treatment. (Clinical trial registration number: NCT04203667.).

Classification, outcomes, and management of misdeployed stents during EUS-guided gastroenterostomy.

BACKGROUND AND AIMS: Stent misdeployment (SM) has hindered the dissemination of EUS-guided gastroenterostomy (EUS-GE) for gastric outlet obstruction (GOO) management. We aimed to provide a classification system for SM during EUS-GE and study clinical outcomes and management accordingly. METHODS: This is a retrospective study involving 16 tertiary care centers (8 in the United States, 8 in Europe) from March 2015 to December 2020. Patients who developed SM during EUS-GE for GOO were included. We propose classifying SM into 4 types. The primary outcome was rate and severity of SM (per American Society for Gastrointestinal Endoscopy lexicon), whereas secondary outcomes were clinical outcomes and management of dislodgement according to the SM classification type, in addition to salvage management of GOO after SM. RESULTS: From 467 EUS-GEs performed for GOO during the study period, SM occurred in 46 patients (9.85%). Most SMs (73.2%) occurred during the first 13 EUS-GE cases by the performing operators. SM was graded as mild (n = 28, 60.9%), moderate (n = 11, 23.9%), severe (n = 6, 13.0%), or fatal (n = 1, 2.2%), with 5 patients (10.9%) requiring surgical intervention. Type I SM was the most common (n = 29, 63.1%), followed by type II (n = 14, 30.4%), type IV (n = 2, 4.3%), and type III (n = 1, 2.2%). Type I SM was more frequently rated as mild compared with type II SM (75.9% vs 42.9%, P = .04) despite an equivalent rate of surgical repair (10.3% vs 7.1%, P = .7). Overall, 4 patients (8.7%) required an intensive care unit stay (median, 2.5 days). The median length of stay was 4 days after SM. CONCLUSIONS: Although SM is not infrequent during EUS-GE, most are type I, mild/moderate in severity, and can be managed endoscopically with a surgical intervention rate of approximately 11%.

Clinical and technical outcomes of patients undergoing endoscopic ultrasound-guided gastroenterostomy using 20-mm vs. 15-mm lumen-apposing metal stents.

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.

Flexible endoscopic incisional therapy for Zenker's diverticulum (FEIT-Z) is an effective treatment for surgical failures or non-operative patients.

BACKGROUND: Symptomatic Zenker's diverticulum (ZD) occurs mostly in the elderly, who often have significant comorbidities, and poor neck hyperextension, putting them at high risk for surgical management while also increasing the potential of technical failure. Flexible endoscopic incisional therapy for Zenker's diverticulum (FEIT-Z) offers a safe approach to this problem with high technical and clinical success rates. There are limited data on its use following a failed surgical approach or in patients unfit for a surgical approach. The aim of this study was to assess clinical and technical outcomes of FEIT-Z in patients who were non-operative candidates or refused or failed surgical management. METHODS: Patients who underwent FEIT-Z from January 2015 to February 2019 at a tertiary referral center were included. Patient demographics, prior ZD surgical history, procedural data, dysphagia scores, clinical success, and adverse events (AE) were collected. Univariable analysis was performed to assess differences between pre- and post-FEIT-Z dysphagia scores. RESULTS: 30 patients undergoing FEIT-Z were included. Seven had a prior failed ZD surgical approach, 6 refused surgical management, and 17 were deemed to be non-operative candidates based on medical comorbidities. Mean age was 78.4 (± 12.1) and 36.7% were male. Technical success of FEIT-Z was 96.7%. There was a significant improvement in dysphagia scores after FEIT-Z: 2.3 (± 0.64) vs. before, 0.4 (± 0.76) (p < 0.001). Long-term clinical success was achieved in 73.3% of patients. Adverse events were seen in 23.3% of patients; however, these were graded as mild in 85.7% of patients. One microperforation was managed with antibiotics. CONCLUSION: FEIT-Z is a safe procedure with low adverse events and a high rate of technical and clinical success. FEIT-Z can be done in patients who fail previous surgical treatment, refuse a surgical approach, or are not surgical candidates due to medical comorbidity or other factors.

Safety and Efficacy of Endoscopic Retrograde Cholangiopancreatography in Nonagenarians: A Systematic Review and Meta-Analysis.

BACKGROUND: Recent advances in modern medicine have translated into increase in life expectancy in the USA and with that, a rise in the demand for invasive procedures in elderly patients. Endoscopic retrograde cholangiopancreatography (ERCP) is the procedure of choice for managing various benign and malignant pancreatobiliary conditions and can be associated with various adverse events. AIM: We performed a systematic review and meta-analysis to evaluate outcomes of ERCP in nonagenarians. METHODS: A comprehensive literature search was performed in Embase, MEDLINE, Web of Science, and Cochrane Review library until July 2020. Our primary outcomes were the rate of technical success and adverse events in nonagenarians. Secondary outcomes were comparison of technical success and adverse events compared with younger patients. RESULTS: The initial search revealed 4933 studies, of which 24 studies with 5521 patients met our inclusion criteria. Pooled technical success rate of ERCP in nonagenarians was 92%, and pooled adverse event rate was 7.8%. There was no significant difference in technical success rate and overall rate of adverse events comparing ERCP outcomes in nonagenarians with a relatively younger population. The risk of post-ERCP bleeding was significantly higher in nonagenarians compared to younger patients with OR = 1.986 [1.113-3.544], I2 = 0. ERCP-related mortality was also significantly higher in nonagenarians compared to younger patients with OR = 4.720 [1.368-16.289], I2 = 0. CONCLUSION: There was no significant difference in technical success rate and risk of adverse events related to ERCP in nonagenarians compared to younger patients. However, the risk of bleeding and procedure-related mortality was significantly higher.

Identifying Gender Barriers for Colorectal Cancer Screening and Assessing the Need for a Multigender Endoscopy Team: A Prospective Multicenter Study.

INTRODUCTION: Gender preferences have been reported as a barrier to colorectal cancer screening, particularly among women. We aim to identify the role of patients' gender preferences for endoscopists and endoscopy team members, with the effect of age-related and regional differences. METHODS: We conducted an anonymous, voluntary survey of all adult outpatients presenting at our endoscopy centers before their procedures. RESULTS: We received 2,138 (1,207 women, 905 men, and 26 undisclosed; 50% urban and 50% rural) completed surveys. The majority of the patients (89%) did not have an endoscopist gender preference, while 8% preferred a same-gender endoscopist, and 2% preferred an opposite gender endoscopist. Among patients who expressed a gender preference, men more commonly preferred a same-gender endoscopist than women (91% vs 67%, P < 0.05). More patients preferred a same-gender endoscopy team member than a same-gender endoscopist (17% vs 8%, P < 0.05), and women more commonly preferred a same-gender endoscopy team member than men (26% vs 6%, P < 0.05). Most patients who expressed same-gender endoscopist preference were between the ages of 50-69 years as compared to other age groups (P < 0.05). Of the urban patients, 9% expressed a same-gender endoscopist preference and 3% expressed an opposite gender preference, compared with 7% and 2% of rural patients (P < 0.05). Among patients with any endoscopist gender preference, rural patients were more willing to wait longer (41% vs 21%, P < 0.05), whereas urban patients were willing to pay more (64% vs 14%, P < 0.05) to have their preferences met. DISCUSSION: Contrary to previous studies, most patients did not have an endoscopist gender preference. Interestingly, men had more same-gender endoscopist preference, whereas women had more same-gender endoscopy team member preference. Age-related and regional differences exist among patients' gender preferences for their endoscopist and endoscopy team member, and addressing these preferences while creating an environment of a multigender endoscopy team may be beneficial in improving colorectal cancer screening.

Single-pass 1-needle actuation versus single-pass 3-needle actuation technique for EUS-guided liver biopsy sampling: a randomized prospective trial (with video).

BACKGROUND AND AIMS: Several reports have validated EUS-guided liver biopsy sampling (EUS-LB) as safe and effective. Nineteen-gauge EUS aspiration (FNA) or core (fine-needle biopsy [FNB]) needles are used, but different needle techniques can yield variable outcomes. Some data show that 1 pass (single liver puncture) with 1 actuation (1 to-and-fro needle movement) may be enough to obtain a satisfactory specimen. However, there has not been a head-to-head comparison of single versus multiple needle actuations for EUS-LB. METHODS: This was a prospective randomized trial of EUS-LB in 40 patients comparing tissue yields and adequacy using 1 pass, 1 actuation (1:1) versus 1 pass 3 actuations (1:3) of an FNB needle. The primary outcome was number of complete portal triads (CPTs). Secondary outcomes were length of the longest piece, aggregate specimen length, number of cores >9 mm, and adverse events (AEs). Computerized randomization determined selection (either 1:1 or 1:3 with fanning technique). Sample lengths were measured before pathologic processing. RESULTS: Both groups had similar demographics and indications for EUS-LB. All biopsy samples were adequate for pathologic interpretation. Compared with 1:1, biopsy sampling with 1:3 yielded more CPTs (mean [standard deviation], 17.25 [6.2] vs 24.5 [9.88]; P < .008) and longer aggregate specimen length (6.89 cm [1.86] vs 12.85 cm [4.02]; P < .001). AEs were not statistically different between the techniques. No severe AEs were noted. CONCLUSIONS: EUS-LB using the 1:3 technique produced longer liver cores with more CPTs than the 1:1 technique with an equivalent safety profile. Two needle passes are more likely to provide tissue adequacy according to the American Association for the Study of Liver Diseases guidelines. (Clinical trial registration number: UMIN 000040101.).

Initial multicenter experience with nitrous oxide cryoballoon for treatment of flat duodenal adenomas (with video).

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 naÏve. 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.

Maximizing success in single-session EUS-directed transgastric ERCP: a retrospective cohort study to identify predictive factors of stent migration.

BACKGROUND AND AIMS: EUS-directed transgastric ERCP (the EDGE procedure) is a simplified method of performing ERCP in Roux-en-Y gastric bypass patients. The EDGE procedure involves placement of a lumen-apposing metal stent (LAMS) into the excluded stomach to serve as a conduit for passage of the duodenoscope for pancreatobiliary intervention. Originally a multistep process, urgent indications for ERCP have led to the development of single-session EDGE (SS-EDGE) with LAMS placement and ERCP performed in the same session. The goal of this study was to identify predictive factors of intraprocedural LAMS migration in SS-EDGE. METHODS: We conducted a multicenter retrospective review that included 9 tertiary medical centers across the United States. Data were collected and analyzed from 128 SS-EDGE procedures. The primary outcome was intraprocedural LAMS migration. Secondary outcomes were other procedural adverse events such as bleeding and perforation. RESULTS: Eleven LAMS migrations were observed in 128 procedures (8.6%). Univariate analysis of clinically relevant variables was performed, as was a binary logistic regression analysis of stent diameter and stent dilation. This revealed that use of a smaller (15 mm) diameter LAMS was an independent predictor of intraprocedural stent migration (odds ratio, 5.36; 95% confidence interval, 1.29-22.24; P = .021). Adverse events included 3 patients who required surgery and 2 who experienced intraprocedural bleeding. CONCLUSIONS: Use of a larger-diameter LAMS is a predictive factor for a nonmigrated stent and improved procedural success in SS-EDGE. Although larger patient cohorts are needed to adequately assess these findings, performance of LAMS dilation and fixation may also decrease risk of intraprocedural LAMS migration and improve procedural success.

Evaluating learning curves and competence in colorectal EMR among advanced endoscopy fellows: a pilot multicenter prospective trial using cumulative sum analysis.

BACKGROUND AND AIMS: Data on colorectal EMR (C-EMR) training are lacking. We aimed to evaluate C-EMR training among advanced endoscopy fellows (AEFs) by using a standardized assessment tool (STAT). METHODS: This multicenter prospective study used a STAT to grade AEF training in C-EMR during their 12-month fellowship. Cumulative sum analysis was used to establish learning curves and competence for cognitive and technical components of C-EMR and overall performance. Sensitivity analysis was performed by varying failure rates. AEFs completed a self-assessment questionnaire to assess their comfort level with performing C-EMR at the completion of their fellowship. RESULTS: Six AEFs (189 C-EMRs; mean per AEF, 31.5 ± 18.5) were included. Mean polyp size was 24.3 ± 12.6 mm, and mean procedure time was 22.6 ± 16.1 minutes. Learning curve analyses revealed that less than 50% of AEFs achieved competence for key cognitive and technical C-EMR endpoints. All 6 AEFs reported feeling comfortable performing C-EMR independently at the end of their training, although only 2 of them achieved competence in their overall performance. The minimum threshold to achieve competence in these 2 AEFs was 25 C-EMRs. CONCLUSIONS: A relatively low proportion of AEFs achieved competence on key cognitive and technical aspects of C-EMR during their 12-month fellowship. The relatively low number of C-EMRs performed by AEFs may be insufficient to achieve competence, in spite of their self-reported readiness for independent practice. These pilot data serve as an initial framework for competence threshold, and suggest the need for validated tools for formal C-EMR training assessment.

Practice patterns, techniques, and outcomes of flexible endoscopic myotomy for Zenker's diverticulum: a retrospective multicenter study.

BACKGROUND: Flexible endoscopic myotomy has been increasingly performed for Zenker's diverticulum using various endoscopic techniques and devices. The main aims of this study were to assess practice patterns and compare outcomes of endoscopic myotomy for Zenker's diverticulum. METHODS: Procedures performed at 12 tertiary endoscopy centers from 1/2012 to 12/2018 were reviewed. Patients (≥ 18 years) with Zenker's diverticulum who had dysphagia and/or regurgitation and underwent endoscopic myotomy were included. Outcomes assessed included technical success, clinical success, and adverse events. RESULTS: 161 patients were included. Traditional endoscopic septotomy was performed most frequently (137/161, 85.1 %) followed by submucosal dissection of the septum and myotomy (24/161, 14.9 %). The hook knife (43/161, 26.7 %) and needle-knife (33/161, 20.5 %) were used most frequently. Overall, technical and clinical success rates were 98.1 % (158/161) and 78.1 % (96/123), respectively. Adverse events were noted in 13 patients (8.1 %). There was no significant difference in technical and clinical success between traditional septotomy and submucosal dissection groups (97.1 % vs. 95.8 %, P = 0.56 and 75.2 % vs. 90.9 %, P  = 0.16, respectively). Clinical success was higher with the hook knife (96.7 %) compared with the needle-knife (76.6 %) and insulated tip knife (47.1 %). Outcomes were similar between centers performing > 20, 11 - 20, and ≤ 10 procedures. CONCLUSIONS: Flexible endoscopic myotomy is an effective therapy for Zenker's diverticulum, with a low rate of adverse events. There was no significant difference in outcomes between traditional septotomy and a submucosal dissection approach, or with centers with higher volume, though clinical success was higher with the hook knife.

Endoscopic ultrasound-directed transgastric ERCP (EDGE): a retrospective multicenter study.

BACKGROUND: Endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP; EDGE) is an alternative to enteroscopy- and laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass anatomy. Although short-term results are promising, the long-term outcomes are not known. The aims of this study were: (1) to determine the rates of long-term adverse events after EDGE, with a focus on rates of persistent gastrogastric or jejunogastric fistula; (2) to identify predictors of persistent fistula; (3) to assess the outcomes of endoscopic closure when persistent fistula is encountered. METHODS: This was a multicenter retrospective study involving 13 centers between February 2015 and March 2019. Adverse events were defined according to the ASGE lexicon. Persistent fistula was defined as an upper gastrointestinal series or esophagogastroduodenoscopy showing evidence of fistula. RESULTS: 178 patients (mean age 58 years, 79 % women) underwent EDGE. Technical success was achieved in 98 % of cases (175/178), with a mean procedure time of 92 minutes. Periprocedural adverse events occurred in 28 patients (15.7 %; mild 10.1 %, moderate 3.4 %, severe 2.2 %). The four severe adverse events were managed laparoscopically. Persistent fistula was diagnosed in 10 % of those sent for objective testing (9/90). Following identification of a fistula, 5 /9 patients underwent endoscopic closure procedures, which were successful in all cases. CONCLUSIONS: The EDGE procedure is associated with high clinical success rates and an acceptable risk profile. Persistent fistulas after lumen-apposing stent removal are uncommon, but objective testing is recommended to identify their presence. When persistent fistulas are identified, endoscopic treatment is warranted, and should be successful in closing the fistula.

Review of ERCP Techniques in Roux-en-Y Gastric Bypass Patients: Highlight on the Novel EUS-Directed Transgastric ERCP (EGDE) Technique.

PURPOSE OF REVIEW: Hepatobiliary complications are common in Roux-en-Y gastric bypass (RYGB) patients. Despite development of multiple surgical and endoscopic access techniques over the years, ERCP using standard duodenoscope remains challenging in these patients due to the altered anatomy. RECENT FINDINGS: Limited success with enteroscope-assisted and laparoscope-assisted ERCP led to the evolution of the novel EUS-directed transgastric ERCP (EDGE) procedure, with variations of this technique termed as Gastric Access Temporary for Endoscopy (GATE), EUS-guided TransGastric ERCP (EUS-TG-ERCP), EUS-guided GastroGastrostomy-assisted ERCP (EUS-GG-ERCP), and EUS-directed transgastric intervention (EDGI). EDGE has high technical (100%) and clinical success rates (60-100%), lower adverse event rate (1.5-7.6%), and up to 20% access stent migration rate; without any significant weight changes. EDGE has significantly shorter procedure time (73vs184min), post-procedural hospital stays (0.8vs2.65 days) and is more cost effective compared to other modalities. EDGE technique addresses the challenges of RYGB anatomy as a minimally invasive, clinically successful, fully endoscopic, and cost-effective option. We present a literature review of the EDGE technique from its inception to current, in addition to reviewing other access techniques, their advantages, disadvantages and outcomes.

Multifocal Cryoballoon Ablation for Eradication of Barrett's Esophagus-Related Neoplasia: A Prospective Multicenter Clinical Trial.

INTRODUCTION: Ablation of Barrett's esophagus (BE) is the preferred approach for the treatment of neoplasia without visible lesions. Limited data on cryoballoon ablation (CBA) suggest its potential clinical utility. We evaluated the safety and efficacy of CBA in a multicenter study of patients with neoplastic BE. METHODS: In a prospective clinical trial, 11 academic and community centers recruited consecutive patients with BE of 1-6 cm length and low-grade dysplasia, high-grade dysplasia (HGD), or intramucosal adenocarcinoma (ImCA) confirmed by central pathology. Patients with symptomatic pre-existing strictures or visible BE lesions had dilation or endoscopic mucosal resection (EMR), respectively, before enrollment. A nitrous oxide cryoballoon focal ablation system was used to treat all visible columnar mucosa in up to 5 sessions. Study end points included complete eradication of all dysplasia (CE-D) and intestinal metaplasia (CE-IM) at 1 year. RESULTS: One hundred twenty patients with BE with ImCA (20%), HGD (56%), or low-grade dysplasia (23%) were enrolled. In the intention-to-treat analysis, the CE-D and CE-IM rates were 76% and 72%, respectively. In the per-protocol analysis (94 patients), the CE-D and CE-IM rates were 97% and 91%, respectively. Postablation pain was mild and short lived. Fifteen subjects (12.5%) developed strictures requiring dilation. One patient (0.8%) with HGD progressed to ImCA, which was successfully treated with EMR. Another patient (0.8%) developed gastrointestinal bleeding associated with clopidogrel use. One patient (0.8%) had buried BE with HGD in 1 biopsy, not confirmed by subsequent EMR. DISCUSSION: In patients with neoplastic BE, CBA was safe and effective. Head-to-head comparisons between CBA and other ablation modalities are warranted (clinicaltrials.gov registration NCT02514525).

Emergent versus urgent ERCP in acute cholangitis: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Acute cholangitis is characterized by abdominal pain, fever, and jaundice. Most patients respond to medical management with intravenous hydration and antibiotics. About 20% to 30% require biliary drainage, and ERCP is the procedure of choice. We conducted a systematic review and meta-analysis to evaluate the impact of emergent biliary drainage on patient outcomes. METHODS: A comprehensive literature review was conducted by searching the Embase and PubMed databases from inception to April 2019 to identify all studies that evaluated the impact of timing of ERCP on patient outcomes. Our primary outcome was in-hospital mortality (IHM), and secondary outcomes were length of stay (LOS), organ failure, and 30-day mortality. Fixed and random effects models were used to generate pooled measures of IHM, 30-day mortality, and LOS. RESULTS: Nine observational studies involving 7534 patients were included in the primary meta-analysis. IHM was significantly lower in patients who underwent emergent biliary drainage within 48 hours (odds ratio [OR], 0.52; 95% confidence interval [CI], 0.28-0.98). As a sensitivity analysis, we pooled the data from 2 population registry studies of 81,893 patients, which yielded consistent results for the main outcomes. LOS was also significantly lower in patients who underwent ERCP within 48 hours with a mean difference of 5.56 days (95% CI, 1.59-9.53). Patients who underwent emergent ERCP also had lower odds of 30-day mortality (OR, 0.39; 95% CI, 0.14-1.08) and organ failure (OR, 0.69; 95% CI, 0.33-1.46). CONCLUSIONS: Our study reveals that performing emergent ERCP within 48 hours in patients with acute cholangitis is associated with lower IHM, 30-day mortality, organ failure, and shorter LOS.

Personal Protective Equipment for Endoscopy in Low-Resource Settings During the COVID-19 Pandemic: Guidance From the World Gastroenterology Organisation.

Performance of endoscopic procedures is associated with a risk of infection from COVID-19. This risk can be reduced by the use of personal protective equipment (PPE). However, shortage of PPE has emerged as an important issue in managing the pandemic in both traditionally high and low-resource areas. A group of clinicians and researchers from thirteen countries representing low, middle, and high-income areas has developed recommendations for optimal utilization of PPE before, during, and after gastrointestinal endoscopy with particular reference to low-resource situations. We determined that there is limited flexibility with regard to the utilization of PPE between ideal and low-resource settings. Some compromises are possible, especially with regard to PPE use, during endoscopic procedures. We have, therefore, also stressed the need to prevent transmission of COVID-19 by measures other than PPE and to conserve PPE by reduction of patient volume, limiting procedures to urgent or emergent, and reducing the number of staff and trainees involved in procedures. This guidance aims to optimize utilization of PPE and protection of health care providers.

Histologic Analysis of Endoscopic Ultrasound-Guided Through the Needle Microforceps Biopsies Accurately Identifies Mucinous Pancreas Cysts.

BACKGROUND & AIMS: It is a challenge to accurately assess pancreatic cystic lesions (PCLs) and determine their risk. We compared the yield of tissue acquired with endoscopic ultrasound (EUS)-guided microforceps (through the needle tissue biopsy [TTNB]) with that of samples collected by EUS-guided fine-needle-aspiration (EUS-FNA), and the accuracy of analyses of each sample type in the diagnosis of mucinous PCLs. METHODS: We performed a prospective open-label study of 114 consecutive adults (56.1% women; mean age, 64.2 y) undergoing EUS-FNA evaluation of PCLs (mean size, 35 mm) at 7 centers, from June 20, 2016, through August 31, 2018. Samples were collected from each cyst by FNA and microforceps; samples collected by FNA were analyzed by cytology and samples collected by TTNB were analyzed by histology. Acquisition yield was defined as the percentage of specimens collected that were adequate for cytologic or histologic analysis. Diagnoses of mucinous cysts were made based on identification of pancreatic mucinous epithelium by cytology analysis of FNA samples or histologic analysis of TTNB samples. Surgical specimens were used as the reference standard when available. RESULTS: The EUS-guided microforceps were successfully inserted into 97.4% (111 of 114) of PCLs. Tissue acquisition yield was significantly higher with TTNB (95 of 114; 83.3%) than FNA (43 of 114; 37.7%) (P < .001). Sixty-one PCLs were determined to be mucinous based on TTNB analysis (53.5%) vs 11 with FNA analysis (9.6%) (P < .001). Among PCLs categorized as equivocal, based on the level of carcinoembryonic antigen, TTNB analysis found 50% (41 of 82) to be mucinous and FNA analysis found 8.5% (7 of 82) to be mucinous (P < .001). Findings from analyses of samples collected by TTNB were 100% concordant with findings from histologic analysis of surgical specimens (14 of 14), whereas only 3 of 14 findings from analysis of samples collected by FNA were in agreement with findings from surgical specimens (21.4%) (P < .001). Four of 5 mucinous PCLs with advanced neoplasia (80%) were detected with TTNB compared with none with FNA (P = .04). Self-limited intracystic bleeding occurred in 7 patients (6.1%), and acute pancreatitis in 6 patients (5.3%). CONCLUSIONS: In a multicenter prospective study of patients undergoing EUS-FNA for evaluation of PCLs, we found TTNB collection of tissues for histologic analysis to be safe and feasible, with an acquisition yield of 83.3%. Histologic analysis of samples collected by TTNB identified a larger proportion of mucinous PCLs compared with cytologic analysis of samples collected by FNA-even among samples categorized as equivocal, based on the level of carcinoembryonic antigen. More samples collected by TTNB than FNA were found to have advanced neoplasia. Clinicaltrials.gov no: NCT02979509.