The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of gastrointestinal (GI) endoscopy. Evidence-based methods are used, with a MEDLINE literature search to identify pertinent clinical studies on the topic and a Manufacturer and User Facility Device Experience (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported adverse events (AEs) of a given technology. Both are supplemented by accessing the "related articles"feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Controlled clinical trials are emphasized, but in many cases data from randomized controlled trials are lacking. In such cases, large case series, preliminary clinical studies, and expert opinions are used. Technical data are gathered from traditional and web-basedpublications, proprietarypub-lications, and informal communications with pertinent vendors. Technology status evaluation reports are drafted by 1 or2 members of the American Society for GastrointestinalEndoscopy Technology Committee, reviewed and edited by the committee as a whole, and approved by the Governing Board of the American Society for Gastrointestinal Endoscopy. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through November 2023 for articles related to endoscopic closure of perforations, leaks, and fistulas by using additional relevant key words such as "intestinal fistula," "perforation," "over-the-scope clip," "endoscopic clips," "endoscopic suturing," and "endoscopic closure," among others. Technology status evaluation reports are scientific reviews provided solely for educational and informational purposes. Technology status evaluation reports on emerging technologies are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.
Introduction: Pancreatic Quantitative Sensory Testing (P-QST) is a neurosensory evaluation used to characterize pancreatic pain. Given racial differences in experimental pain sensitivity, it is crucial to investigate this phenomenon before widespread P-QST adoption. We aimed to study experimental pain sensitivity in African American (AA) vs non-AA individuals with no abdominal pain or known pancreatic disease (controls), and AA controls vs AA participants with chronic pancreatitis (CP). Methods: In this cross-sectional, multi-center study, race was dichotomized (AA and non-AA) and was self-reported. Participants underwent P-QST testing assessing pressure pain detection threshold (pPDT), pressure tolerance threshold (pPTT), cold pressor endurance (CPE), conditioned pain modulation (CPM), temporal summation (TS), and the Hospital Anxiety and Depression Scale (HADS). Results: A total of 157 AA and 110 non-AA control participants were tested, as well as 35 AA participants with CP. No differences in P-QST testing were seen between racial groups in control participants. Compared to AA controls, AA participants with CP showed signs of impaired CPM, significantly lower pPTTs and suggestion of lower pPDTs, as well as increased TS scores of the upper abdomen. The lower pPDTs and pPTTs and decreased CPM in AA CP participants compared to AA controls are consistent with findings in other racial groups. Conclusion: No significant differences in experimental pain results were found between AA and non-AA controls. Alterations in experimental pain sensitivity appear to mainly accompany the CP disease state in the group of AA participants studied.
BACKGROUND:EUS-guided gastroenterostomy (EUS-GE) is an effective option for the management of gastric outlet obstruction (GOO). Due to the poor prognosis of patients undergoing it, data on its long-term adverse events (AE) is scarce. Herein, we describe a cohort of patients with gastro-entero-colic fistula (GECF) as a late AE of previously successful EUS-GE. METHODS:Patients who developed a GECF after EUS-GE from 10 high-volume centers were analyzed. Information collected included demographic characteristics, indications, clinical and technical success rates, stent type and size, fistula characteristics, management, and outcomes. RESULTS:Sixteen cases were identified. The mean interval from index EUS-GE to the diagnosis of GECF was 4 to 8 weeks. The most common cause of GOO was pancreatic adenocarcinoma (PDAC). The transverse colon was the most common site for the GECF (14 patients). A 20×10 mm lumen apposing metal stent (LAMS) was utilized in 10 patients. Endoscopic management with a variety of modalities was successful in 13 cases. Follow-up interval after endoscopic management of the fistula averaged 2 to 4 weeks. At the time of the manuscript elaboration, 10 patients had died, 5 were alive, and 1 was lost to follow-up. CONCLUSIONS:This is the first description of a cohort of patients with GECF after EUS-GE. The exact mechanisms leading to GECF in these cases are unknown. Possible explanations include inadvertent colon puncture during the index procedure and/or entrapment of mesocolon. More data is needed to further characterize this AE.
Background and Aims EUS-guided gastroenterostomy (EUS-GE) is an effective option to palliate symptoms of gastric outlet obstruction (GOO). While the jejunum is conventionally targeted (EUS-GJ), targeting the duodenum (EUS-GD) may offer clinical advantages. Outcomes were compared for EUS-GJ and EUS-GD. Methods Adult patients who underwent EUS-GE for GOO between 2020 and 2024 were included and categorized as an EUS-GD if the stent entered the transverse or ascending duodenum or an EUS-GJ if the stent entered more distally. The primary outcome was clinical success (soft diet tolerance at 7 days). Secondary outcomes included adverse events (AEs), stent misdeployment, and unplanned endoscopic reintervention. Baseline demographic variables and outcomes were compared with statistical significance at p < 0.05. Results Of the 139 included patients (median age 67 years (IQR 61-74); 41% female), 105 underwent EUS-GJ and 34 underwent EUS-GD. Clinical success was 98% for EUS-GJ and 94% for EUS-GD ( p = 0.25). The misdeployment rate was 7% for EUS-GJ and 0% for EUS-GD ( p = 0.19). The AE rate was 22% for EUS-GJ and 12% for EUS-GD ( p = 0.23). There were no significant differences for stent obstruction (EUS-GJ 12% vs. EUS-GD 6%), bleeding (2% vs. 6%), perforation (4% vs. 0%), stent migration (1% vs. 0%), infection (3% vs. 0%), and unplanned reintervention (14% vs. 9%). Conclusion Both EUS-GJ and EUS-GD demonstrate high clinical success with no significant differences in adverse event rates. These data can support intraprocedural decision-making for endoscopists performing EUS-GE.
INTRODUCTION:Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with lumen-apposing metal stents (LAMS) is an effective strategy for high-risk surgical patients. The optimal access route-transgastric (TG) versus transduodenal (TD)-remains uncertain. We compared outcomes of TG versus TD EUS-GBD at a high-volume tertiary center. METHODS:We included patients who underwent EUS-GBD between January 2020 and December 2024. Baseline demographics, clinical variables, and outcomes data were collected. The primary outcome was clinical success, defined as resolution of cholecystitis or relief of biliary obstruction. Secondary outcomes included stent misdeployment, adverse events (AEs), and need for endoscopic reintervention. Comparisons were performed using the unpaired T-test, Mann-Whitney U test, and Fisher's exact test, with significance at p < 0.05. RESULTS:We included 82 patients (mean age 72 years, 48% female). The indication for drainage was cholecystitis for 45 (55%) patients and MDBO with a patent cystic duct and prior failed ERCP for 37 (45%) patients. Sixty-four (78%) patients underwent transduodenal (TD) EUS-GBD and 18 (22%) underwent transgastric (TG) EUS-GBD. There was no difference between the two groups for clinical success (TD 89% vs. TG 94%, p = 0.68) overall nor when evaluated by procedural indication. There were five (8%) cases of stent misdeployment in the TD EUS-GBD group and zero cases in the TG EUS-GBD group (p = 0.58), all of which were salvaged endoscopically. There were no significant differences between groups for AEs (20% vs. 17%, p = > 0.99) or unplanned endoscopic reintervention (16% vs. 11%, p = > 0.99). CONCLUSIONS:Both TG and TD EUS-GBD are effective and relatively safe, supporting an individualized approach based on technical feasibility and future surgical candidacy. A potential trend toward more misdeployments in the TD EUS-GBD group warrants further study.
OBJECTIVES:Smoking is a key risk factor for pancreatitis, contributing to pathogenesis and disease progression. Data regarding second-hand smoking, or passive smoking (PS) exposure, are lacking. We therefore aimed to assess the impact of PS exposure across the pancreatitis spectrum. METHODS:We analyzed baseline data from the PROCEED study, a multicenter study in the United States including patients with acute (AP), recurrent acute (RAP), and chronic (CP) pancreatitis. Participants detailed their individual smoking history and PS exposure, which was compared between AP, RAP, and CP subgroups. Participant factors and clinical characteristics were compared by level of individual and PS exposure. RESULTS:Among 1369 participants (190 AP, 498 RAP, 681 CP), 346 (25.3%) were current and 409 (29.9%) were former smokers. The CP subgroup had the highest proportion of current smokers (36.7% CP vs 15.1% RAP, 11.1% AP, P < 0.001). PS exposure was also significantly higher in the CP subgroup (68.6% CP vs 58.2% RAP, 55.3% AP, P < 0.001). A minority (16.3%) with CP reported no smoking exposure (by self or passive) while nearly half smoked ≥20 pack-years. The mean PS duration was significantly higher in CP participants (21.8 y) compared with those with AP (17.8 y) or RAP (18.9 y) ( P < 0.0166). CONCLUSIONS:In this multicenter study, we affirmed an association with smoking use and intensity with CP-related complications. For the first time, we report a high prevalence of prior exposure to passive smoking in all pancreatitis subtypes, which requires further study to understand the impact on disease outcomes.
Background: Self-expanding metal stents (SEMS) are recommended for the endoscopic palliation of distal malignant biliary obstruction (DMBO). Placement of SEMS during endoscopic retrograde cholangiopancreatography (ERCP) has been associated with an increased risk of post-ERCP pancreatitis (PEP). Objectives: The aim of this study is to evaluate rates of PEP in patients who underwent SEMS placement for pancreatic versus non-pancreatic malignancy. Design: Retrospective Cohort Study. Methods: Patients who underwent SEMS placement for DMBO between June 2017 and May 2021 were identified retrospectively from a procedural billing database. PEP incidence was compared between pancreatic and non-pancreatic DMBO groups and multivariate logistic regression was performed to identify risk factors for PEP. Results: A total of 488 individuals were identified, with 395 (80.9%) cases of DMBO due to pancreatic and 93 (19.1%) due to non-pancreatic malignancy. Stent types included 124 (25.4%) fully covered (FCSEMS) and 364 (74.6%) uncovered metal stents (UCSEMS). The overall rate of PEP in the cohort was 6.3% with no significant difference between pancreatic and non-pancreatic etiologies (6.1% vs 7.5%, p = 0.606). When adjusted for age <50 years old, female sex, and pancreatic stent placement, a non-pancreatic malignancy was not associated with an increased risk of PEP (OR 0.83, 95% CI 0.36–2.15). Conclusion: No statistically significant difference in PEP rates was seen after biliary sphincterotomy and SEMS placement for palliation of DMBO in patients with pancreatic versus non-pancreatic malignancies.
Background:EUS-guided gastroenterostomy (EUS-GE) is an effective option for the management of gastric outlet obstruction (GOO). Due to the poor prognosis of patients undergoing it, data on its long-term adverse events (AE) is scarce. Herein, we describe a cohort of patients with gastro-entero-colic fistula (GECF) as a late AE of previously successful EUS-GE.Methods:Patients who developed a GECF after EUS-GE from 10 high-volume centers were analyzed. Information collected included demographic characteristics, indications, clinical and technical success rates, stent type and size, fistula characteristics, management, and outcomes.Results:Sixteen cases were identified. The mean interval from index EUS-GE to the diagnosis of GECF was 4 to 8 weeks. The most common cause of GOO was pancreatic adenocarcinoma (PDAC). The transverse colon was the most common site for the GECF (14 patients). A 20 & times;10 mm lumen apposing metal stent (LAMS) was utilized in 10 patients. Endoscopic management with a variety of modalities was successful in 13 cases. Follow-up interval after endoscopic management of the fistula averaged 2 to 4 weeks. At the time of the manuscript elaboration, 10 patients had died, 5 were alive, and 1 was lost to follow-up.Conclusions:This is the first description of a cohort of patients with GECF after EUS-GE. The exact mechanisms leading to GECF in these cases are unknown. Possible explanations include inadvertent colon puncture during the index procedure and/or entrapment of mesocolon. More data is needed to further characterize this AE.
BACKGROUND & AIMS:Tools that can predict recurrence in patients with Barrett's esophagus (BE)-related neoplasia treated with endoscopic eradication therapies (EET) to guide surveillance decisions are needed. We aimed to develop and validate a machine learning (ML)-based prediction tool to predict the risk and timing of recurrence status post EET. METHODS:Three prospective United States databases of patients who underwent EET for BE-related neoplasia and achieved complete eradication of intestinal metaplasia (CE-IM; n = 1114) were utilized to develop and internally validate a ML-based prediction tool using the Random Forest model and imputation techniques. Predictors incorporated in this model included demographics, endoscopy and pathology results, and EET details. A Cox proportional hazards model was utilized to predict the time to recurrence. External validation was performed using the United States Radiofrequency Ablation database (n = 1397). RESULTS:BE recurrence occurred in 29.2% (n = 734) of patients and BE-related neoplasia recurrence in 10.6% (n = 265), with a mean time to recurrence of 21.3 months (mean follow-up, 37.7 months). The top predictors for recurrence included BE length, body mass index, age, sessions needed to achieve CE-IM, and baseline histology. The model was well-calibrated, and area under the receiver operating characteristic curve (AUC) was 0.92 (95% confidence interval [CI], 0.85-0.95) on internal validation and 0.91 (95% CI, 0.87-0.95) on external validation for BE recurrence. For BE-related neoplasia recurrence, the AUC was 0.90 (95% CI, 0.88-0.93). The model had moderate discriminative performance to predict timing of recurrence with a C-index of 0.701 at 1 year (AUC 0.71), 0.68 (AUC 0.69) at 3 years, and 0.66 (AUC 0.69) at 5 years. CONCLUSIONS:This United States-based externally validated tool accurately predicts BE and BE-related neoplasia recurrence and timing post EET. This practical tool may help provide a personalized approach to surveillance strategies.