Evaluating no fixation, endoscopic suture fixation, and an over-the-scope clip for anchoring fully covered self-expanding metal stents in benign upper gastrointestinal conditions: a comparative multicenter international study (with video).

BACKGROUND AND AIMS: Fully covered self-expandable metal stents (FCSEMSs) are widely used in benign upper gastrointestinal (GI) conditions, but stent migration remains a limitation. An over-the-scope clip (OTSC) device (Ovesco Endoscopy) for stent anchoring has been recently developed. The aim of this study was to evaluate the effect of OTSC fixation on SEMS migration rate. METHODS: A retrospective review of consecutive patients who underwent FCSEMS placement for benign upper GI conditions between 1/2011 and 10/2022 at 16 centers. The primary outcome was rate of stent migration. The secondary outcomes were clinical success and adverse events. RESULTS: A total of 311 (no fixation 122, OTSC 94, endoscopic suturing 95) patients underwent 316 stenting procedures. Compared to the no fixation (NF) group (n=49, 39%), the rate of stent migration was significantly lower in the OTSC (SF) (n=16, 17%, p=0.001) and endoscopic suturing (ES) group (n=23, 24%, p=0.01). The rate of stent migration was not different between the SF and ES groups (p=0.2). On multivariate analysis, SF (OR 0.34, CI 0.17-0.70, p<0.01) and ES (OR 0.46, CI 0.23-0.91, p=0.02) were independently associated with decreased risk of stent migration. Compared to the NF group (n=64, 52%), there was a higher rate of clinical success in the SF (n=64, 68%; p=0.03) and ES group (n=66, 69%; p = 0.02). There was no significant difference in the rate of adverse events between the three groups. CONCLUSION: Stent fixation using OTSC is safe and effective at preventing stent migration and may also result in improved clinical response.

SHORT ESOPHAGEAL MYOTOMY VERSUS STANDARD MYOTOMY FOR TREATMENT OF SIGMOID-TYPE ACHALASIA: RESULTS OF AN INTERNATIONAL, MULTICENTER STUDY.

BACKGROUND AND AIMS: Patients with sigmoid-type achalasia can be challenging to treat with per-oral endoscopic myotomy (POEM). A short myotomy improves technical success, however outcomes have not previously been evaluated METHODS: This was a multicenter, international, retrospective study of patients who underwent POEM with short (≤ 4 cm) or standard esophageal myotomy. Outcomes included clinical and technical success, procedural adverse events, and reflux rates. RESULTS: A total of 109 patients with sigmoid achalasia (sigmoid = 74, advanced sigmoid = 35) underwent POEM across 13 centers (Short myotomy = 59, standard = 50). Technical success was 100% across both groups. Patients who underwent short myotomy had a significantly shorter mean procedure time (57.7 ± 27.8 vs 83.1 ± 44.7 minutes, p = 0.0005). A total of 6 AEs were recorded in 6 patients (5.5%; 4 mild, 2 moderate); AE rate was not significantly different between short and standard groups. Ninety-eight patients had follow-up data (median = 3.6 months [IQR, 1-14]) months). Clinical success was 94% (short = 93%; standard = 95%, p = 0.70) and did not differ based on achalasia subtype or sigmoid achalasia severity. Twenty-one (22%) patients reported post-POEM reflux and 44% (16/36) had objective evidence of pathologic reflux. Rates of pathologic reflux were significantly increased in the standard vs short group (OR 18.0 [95% CI: 2.0 - 159.0]; p = 0.009). CONCLUSIONS: POEM with short myotomy is effective and safe for the short-term treatment of sigmoid and advanced sigmoid achalasia. Short myotomy may lead to less reflux than standard myotomy.

A location-based anatomic classification system for acute pancreatic fluid collections: Roadmap for optimal intervention in the step-up era.

Walled-off pancreatic necrosis (WOPN) is a local complication of acute necrotizing pancreatitis frequently requiring intervention. Treatment is typically through the coordinated efforts of a multidisciplinary team. Current management guidelines recommend a step-up approach beginning with minimally invasive techniques (percutaneous or transmural endoscopic drainage) followed by escalation to more invasive procedures if needed. Although the step-up approach is an evidence-based treatment paradigm for management of pancreatic fluid collections, it lacks guidance regarding optimal invasive technique selection based on the anatomic characteristics of pancreatic fluid collections. Similarly, existing cross-sectional imaging-based classification systems of pancreatic fluid collections have been used to predict disease severity and prognosis; however, none of these systems are designed to guide intervention. We propose a novel classification system which incorporates anatomic characteristics of pancreatic fluid collections (location and presence of disconnected pancreatic duct) to guide intervention selection and clinical decision making. We believe adoption of this simple classification system will help streamline treatment algorithms and facilitate cross-study comparisons for pancreatic fluid collections.

Clinical outcomes of long-term transmural drainage with double pigtail stents in disconnected pancreatic duct syndrome.

Background: Disconnected pancreatic duct syndrome (DPDS) is a common cause of recurrent pancreatic fluid collections (PFCs), often requiring repeat drainage. Following initial drainage with lumen apposing metal stents (LAMS), replacement with transmural double pigtail stents (DPS) has been shown to be a viable drainage modality mitigating the risk of recurrence. The sparsity of literature on the consequences of this strategy requires further investigation. We analyze our outcomes of long-term transmural drainage with DPS in patients with DPDS and assess the safety and efficacy of this technique. Methods: This retrospective review of a prospectively maintained database from November 2015-May 2022 included all patients with DPDS who underwent removal of LAMS and replacement with long-term transmural DPS. Patient demographics, collection characteristics, drainage technique and outcomes, as well as follow-up data was collected and analyzed using descriptive statistics. Results: There were 139 patients who underwent endoscopic drainage of PFCs with LAMS during the study period. Seventy-eight patients [walled-off necrosis (n=65) and pseudocysts (n=13)] were found to have DPDS. Of these, 44 patients underwent successful LAMS removal followed by replacement with DPS and were included in the analysis. The median age was 57 years and 14 (32%) were female. The median stent dwell time was 394 days [interquartile range (IQR) 245, 853 days]. Spontaneous stent migration was seen in seven patients (16%), one of whom developed a PFC recurrence which was managed conservatively. The second recurrence was seen in a patient with indwelling DPS which did not require further intervention. There were no locoregional adverse events secondary to long-term indwelling DPS. Among the 28 patients who were followed for a year, three patients developed new-onset diabetes, and chronic pancreatitis (CP) changes in the disconnected segment were seen in eight patients, five of whom required pancreatic enzyme supplementation. Conclusions: Placement of long-term transmural DPS is an effective modality for preventing collection re-accumulation with a favorable safety profile. Randomized prospective studies are essential to investigate the optimal removal timing of indwelling stents to prevent loco-regional complications. Given the realized risk of CP in the disconnected pancreas, follow-up cross sectional imaging may help guide further therapy.

EUS-guided hepaticogastrostomy versus percutaneous transhepatic biliary drainage after failed ERCP: A propensity score-matched analysis.

Background and study aims Percutaneous transhepatic biliary drainage (PTBD) is the traditional second-line option after unsuccessful endoscopic retrograde cholangiopancreatography (ERCP). Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HG) is a viable alternative to PTBD. Our study aimed to compare outcomes of EUS-HG and PTBD for benign and malignant biliary diseases following failed ERCP. Patients and methods This single-center study retrospectively analyzed patients undergoing EUS-HG and PTBD for benign and malignant biliary disorders. A propensity score-matched analysis was performed using age, sex, and Charlson Comorbidity Index. The primary outcome was clinical success, which we defined as a decrease in total bilirubin by ≥ 50% at 2 weeks for malignant disease and resolution of the biliary disorder for benign disease. Results In total, 41 patients underwent EUS-HG and 138 patients underwent PTBD. After propensity score matching in a 1:2 ratio, 32 EUS-HG patients were matched with 64 PTBD. Technical success was achieved in 29 of 32 (91%) for EUS-HG and 63 of 64 (98%) for PTBD ( P =0.11). Clinical success was 100% for EUS-HG and 75% for PTBD ( P =0.0021). EUS-HG was associated with a lower adverse event rate (EUS-HG 13% vs. PTBD 58%, P <0.0001), shorter procedure duration (median 60 vs. 115 minutes, P <0.0001), shorter post-procedure length of stay (median 2 vs. 4 days, P <0.0001), and fewer reinterventions (median 1 vs. 3, P <0.0001). Conclusions Our results suggest that EUS-HG is superior to PTBD in the treatment of benign and malignant biliary disorders after failed ERCP.

Enteroscopy-Assisted EUS-Guided Trans-gastric Intervention After Roux-en-Y Gastric Bypass Surgery.

Endoscopic ultrasound-directed trans-gastric interventions (EDGI) using lumen apposing metal stent (LAMS) have been increasingly utilized in patients with Roux-en-Y gastric bypass surgery. We present a case of a 71-year-old woman with Roux-en-Y anatomy presenting with choledocholithiasis and enlarged retroperitoneal lymph nodes. Given inability to identify the excluded stomach on routine EUS, enteroscopy was performed with retrograde filling of the excluded stomach to allow for its localization on EUS. The patient underwent LAMS placement to create a jejuno-gastric anastomosis. Subsequently, she had an ERCP (via the LAMS) for removal of bile duct stone and an EUS with fine needle aspiration of the para-aortic lymph node (via the LAMS) confirming malignancy. The LAMS was removed after 2 weeks and the defect closed with APC and clips. An upper GI series obtained at 4 weeks did not show any residual leak. Patient continues to follow up with oncology for workup of primary malignancy.

Analysis of adverse events with lumen apposing metal stents for drainage of pancreatic fluid collections.

Background and study aims Innovations in endoscopic management of pancreatic fluid collections (PFCs) using lumen apposing metal stents (LAMS) have rendered it a preferred approach for drainage of PFCs. These advances have not come without concern for adverse events (AEs). We present our experience with LAMS for drainage of PFCs and analyze factors that contribute to LAMS-related AEs. Patients and methods From November 2015 to October 2021, a retrospective analysis was performed of patients undergoing endoscopic management of PFCs using LAMS. All AEs were classified as either early (<48 hours) or late (>48 hours). Univariate and multivariate analysis were performed using logistic regression to assess the relationship between independent variables and AEs. Results A total of 119 patients with symptomatic PFCs underwent endoscopic drainage with LAMS. There were 16 AEs (12.4%). These included systemic inflammatory response syndrome (SIRS) (n=2), stent occlusion (n=5), bleeding (n=7), and stent migration (n=2). Univariate analysis of risk of AEs showed that no variables approached statistical significance. Of the seven patients who developed bleeding, five had pseudoaneurysms following LAMS placement and underwent angioembolization by an interventional radiologist. The average time to bleeding was 9.3 days (standard deviation 7.3) with all bleeding events occurring within 3 weeks. In a multivariate model, pseudocysts and presence of paracolic gutter extension were associated with an increased risk of bleeding. Conclusions Endoscopists should be aware of the risk factors for LAMS-related bleeding and tailor their drainage strategy, including utilization of plastic stents for drainage of pseudocysts and adherence to a strict imaging interval and follow-up protocol.

Endoscopic Ultrasound-Guided Gastro-gastrostomy Using Lumen Apposing Metal Stent for Management of High-Grade Gastric Outlet Obstruction Secondary to Vertical Banded Gastroplasty.

Vertical banded gastroplasty (VBG) is associated with an increased risk of pouch stricture secondary to narrowing of the banded gastroplasty outlet. We describe a case of a 60-year-old male with stage 4 small cell lung cancer presenting with recurrent gastric outlet obstruction secondary to stenosis at the site of VBG. Given a prior history of failed standard endoscopic maneuvers including balloon dilation and steroid injection, the decision was made to create an endoscopic ultrasound-guided gastro-gastrostomy using lumen opposing metal stent. The patient did well post procedure and was able to tolerate a soft mechanical diet within 24 h. He was subsequently discharged to hospice for his advanced metastatic disease.

Endoscopic Ultrasound-Guided Gallbladder Drainage: Beyond Cholecystitis.

Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is an alternative to surgery for acute cholecystitis (AC) in poor operative candidates. However, the role of EUS-GBD in non-cholecystitis (NC) indications has not been well studied. We compared the clinical outcomes of EUS-GBD for AC and NC indications. Consecutive patients undergoing EUS-GBD for all indications at a single center were retrospectively analyzed. Fifty-one patients underwent EUS-GBD during the study period. Thirty-nine (76%) patients had AC while 12 (24%) had NC indications. NC indications included malignant biliary obstruction (n = 8), symptomatic cholelithiasis (n = 1), gallstone pancreatitis (n = 1), choledocholithiasis (n = 1), and Mirizzi's syndrome (n = 1). Technical success was noted in 92% (36/39) for AC and 92% (11/12) for NC (p > 0.99). The clinical success rate was 94% and 100%, respectively (p > 0.99). There were four adverse events in the AC group and 3 in the NC group (p = 0.33). Procedure duration (median 43 vs. 45 min, p = 0.37), post-procedure length of stay (median 3 vs. 3 days, p = 0.97), and total gallbladder-related procedures (median 2 vs. 2, p = 0.59) were similar. EUS-GBD for NC indications is similarly safe and effective as EUS-GBD in AC.

Pancreatic Cancer Screening for At-Risk Individuals (Pancreas Scan Study): Yield, Harms, and Outcomes From a Prospective Multicenter Study.

INTRODUCTION: Guidelines endorse pancreatic cancer screening in genetically susceptible individuals. We conducted a prospective, multicenter study to determine yield, harms, and outcomes of pancreatic cancer screening. METHODS: All high-risk individuals undergoing pancreatic cancer screening at 5 centers from 2020 to 2022 were prospectively enrolled. Pancreas findings were designated as low-risk (fatty or chronic pancreatitis-like changes), intermediate-risk (neuroendocrine tumor [NET] <2 cm or branch-duct intraductal papillary mucinous neoplasm [IPMN]), or high-risk lesions (high-grade pancreatic intraepithelial neoplasia/dysplasia, main-duct IPMN, NET >2 cm, or pancreatic cancer). Harms from screening included adverse events during screening or undergoing low-yield pancreatic surgery. Annual screening was performed using endoscopic ultrasound and or magnetic resonance cholangiopancreatography. Annual screening for new-onset diabetes using fasting blood sugar was also performed ( ClinicalTrials.gov : NCT05006131). RESULTS: During the study period, 252 patients underwent pancreatic cancer screening. Mean age was 59.9 years, 69% were female, and 79.4% were White. Common indications were BRCA 1/2 (36.9%), familial pancreatic cancer syndrome kindred (31.7%), ataxia telangiectasia mutated (3.5%), Lynch syndrome (6.7%), Peutz-Jeghers (4.3%), and familial atypical multiple mole melanoma (3.5%). Low-risk lesions were noted in 23.4% and intermediate-risk lesions in 31.7%, almost all of which were branch-duct IPMN without worrisome features. High-risk lesions were noted in 2 patients (0.8%), who were diagnosed with pancreas cancer at stages T2N1M0 and T2N1M1. Prediabetes was noted in 18.2% and new-onset diabetes in 1.7%. Abnormal fasting blood sugar was not associated with pancreatic lesions. There were no adverse events from screening tests, and no patient underwent low-yield pancreatic surgery. DISCUSSION: Pancreatic cancer screening detected high-risk lesions with lower frequency than previously reported. No harms from screening were noted.

Definitive nonsurgical management of stump cholecystitis with EUS-guided lumen-apposing metal stent placement and electrohydraulic lithotripsy.

Video 1Definitive nonsurgical management of stump cholecystitis with EUS-guided lumen-apposing metal stent placement and electrohydraulic lithotripsy.

Endoscopic Ultrasound-Guided Drainage of a Postoperative Fluid Collection in the Setting of Roux-en-Y Anatomy.

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Factors predictive of persistent fistulas in EUS-directed transgastric ERCP: a multicenter matched case-control study.

BACKGROUND AND AIMS: EUS-directed transgastric ERCP (EDGE) is an established method for managing pancreaticobiliary pathology in Roux-en-Y gastric bypass patients, with high rates of technical success and low rates of serious adverse events (AEs). However, widespread adoption of the technique has been limited because of concerns about the development of persistent gastrogastric or jejunogastric fistulas. Gastrogastric and jejunogastric fistulas have been reported in up to 20% of cases in some series, but predictive risk factors and long-term management and outcomes are lacking. Therefore, our aims were to assess factors associated with the development of persistent fistulas and the technical success of endoscopic fistula closure. METHODS: This is a case-control study involving 9 centers (8 USA, 1 Europe) from February 2015 to September 2021. Cases of persistent fistulas were defined as endoscopic or imaging evidence of fistula more than 8 weeks after lumen-apposing metal stent (LAMS) removal. Control subjects were defined as endoscopic or imaging confirmation of no fistula more than 8 weeks after LAMS removal. AEs were defined and graded according to the American Society for Gastrointestinal Endoscopy lexicon. RESULTS: Twenty-five patients identified to have evidence of a persistent fistula on follow-up surveillance (cases) were matched with 50 patients with no evidence of a persistent fistula on follow-up surveillance (control subjects) based on age and sex. Mean LAMS dwell time was 74.7 ± 106.2 days. After LAMS removal, argon plasma coagulation (APC) ablation of the fistula was performed in 46 patients (61.3%). Primary closure of the fistula was performed in 26.7% of patients (20: endoscopic suturing in 17, endoscopic tacking in 2, and over-the-scope clips + endoscopic suturing in 1). When comparing cases with control subjects, there was no difference in baseline demographics, fistula site, LAMS size, or primary closure frequency between the 2 groups (P > .05). However, in the persistent fistula group, the mean LAMS dwell time was significantly longer (127 vs 48 days, P = .02) and more patients had ≥5% total body weight gain (33.3% vs 10.3%, P = .03). LAMS dwell time was a significant predictor of persistent fistula (odds ratio, 4.5 after >40 days in situ, P = .01). The odds of developing a persistent fistula increased by 9.5% for every 7 days the LAMS was left in situ. In patients with a persistent fistula, endoscopic closure was attempted in 19 (76%) with successful resolution in 14 (73.7%). CONCLUSIONS: Longer LAMS dwell time was found to be associated with a higher risk of persistent fistulas in EDGE patients. APC or primary closure of the fistula on LAMS removal was not found to be protective against developing a persistent fistula, which, if present, can be effectively managed through endoscopic closure in most cases.

Delayed endoscopic necrosectomy improves hospital length of stay and reduces endoscopic interventions in patients with symptomatic walled-off necrosis.

Objectives: Advancements in the endoscopic management of walled-off necrosis using lumen apposing metal stents have improved outcomes over its surgical and percutaneous alternatives. The ideal procedural technique and timing of direct endoscopic necrosectomy (DEN) have yet to be clarified. Methods: From November 2015 to June 2021, a retrospective comparative cohort analysis was performed comparing clinical outcomes for patients undergoing immediate DEN (iDEN) versus delayed DEN (dDEN). Subgroups were identified based on the quantification of necrosis. Wilcoxon two-sample tests were used to compare continuous variables and Fisher's exact test was used to compare categorical variables. Results: A total of 80 patients underwent DEN for management of walled-off necrosis (iDEN = 43, dDEN = 37). Technical success was achieved in all patients. Clinical success was seen in 39 (91%) patients in the iDEN group and 34 (92%) in the dDEN group. Amongst iDEN patients, the mean number of necrosectomies was 2.5 (standard deviation [SD] 1.4) in comparison to 1.5 (SD 1.0) for dDEN (p-value = 0.0011). The median index hospital length of stay was longer with iDEN than dDEN (7.5 days vs. 3.0 days respectively, p-value = 0.010). Subgroup analysis was performed based on the percentage of necrosis (<25% vs. >25% necrosis). iDEN was associated with more necrosectomies than dDEN regardless of the percentage of necrosis (p = 0.017 and 0.0067, respectively). Conclusion: Patients undergoing dDEN had a shorter index hospital stay and fewer necrosectomies than iDEN. The large diameter of lumen apposing metal stents permits adequate drainage allowing a less aggressive approach thereby improving clinical outcomes and avoiding unnecessary interventions.

Endoscopic management of hemorrhagic pancreatic fluid collections: A propensity-matched analysis.

Objectives: Hemorrhagic pancreatic fluid collections (hPFC) are a complication of pancreatitis with an unknown influence on prognosis. Advancements in endoscopic management of PFC have improved results over their surgical and percutaneous alternatives. We performed a propensity-matched analysis comparing clinical outcomes in hemorrhagic and non-hemorrhagic PFC (nhPFC). Methods: From November 2015 to November 2021, a retrospective comparative cohort analysis was performed comparing clinical outcomes for patients with hPFC and nhPFC managed with lumen-apposing metal stents. Propensity score matching was used to balance the two subgroups. Wilcoxon two-sample tests were used to compare continuous variables and Fisher's exact test was used to compare categorical variables. Kaplan-Meier method was used to estimate overall survival. Results: Fifteen patients with hPFC were matched with 30 nhPFC patients. Technical and clinical success was similar in both groups. The median length of hospitalization was 6 days in the hPFC group and 3 days in the nhPFC group (p = 0.23); however, more hPFC patients required intensive care unit admission post-procedure (33.3% vs. 16.7%, p = 0.26). Patients with hPFC were more likely to be readmitted to the hospital within 30 days (33.3% vs. 6.7%, p = 0.032). Mortality at 3 months (13% vs 3%, p = 0.25) and 6 months (27% vs. 7%, p = 0.09) was higher in the hPFC cohort. The 1-year survival estimate was 73.3% (standard error = 11.4) in the hPFC group and 88.9% (6.1) in the nhPFC group (p = 0.16). Conclusions: Patients with hPFC are more likely to be readmitted to the hospital within 30 days and have worse clinical outcomes.

Cholecystocolonic fistula following endoscopic ultrasound-guided gallbladder drainage for stump cholecystitis.

Cholecystocolonic fistulas are a rare sequela of gallstone disease. Presenting symptoms are variable but a triad of chronic diarrhea, vitamin K malabsorption, and pneumobilia has been proposed. If untreated, recurrent biliary sepsis can occur with substantial morbidity and mortality. Definitive management is surgical although endoscopic treatment has been described in nonsurgical patients. We present a case of a cholecystocolonic fistula following transgastric endoscopic ultrasound-guided gallbladder drainage with a lumen-apposing metal stent for stump cholecystitis. The patient's presenting symptom was diarrhea. Upper endoscopy and cholecystoscopy 4 weeks following gallbladder drainage revealed a cholecystocolonic fistula. The cholecystogastric tract was closed through the scope clips. The patient had no episodes of cholangitis and had a patent biliary tree with a prior biliary sphincterotomy so clinical observation was chosen. Colonoscopy 1 month later confirmed the closure of the fistula and the patient had a resolution of diarrhea. Our case highlights a novel adverse event of endoscopic ultrasound-guided gallbladder drainage caused by direct pressure of the lumen apposing metal and double pigtail stents on an already inflamed gallbladder wall. Endoscopic therapies that aid in transcapillary biliary drainage are viable alternatives to surgery and can result in fistula closure.

EUS-guided gastrojejunostomy for management of malignant gastric outlet obstruction in a patient with Roux-en-Y anatomy.

Video 1Endoscopic ultrasound-guided gastrojejunostomy.