Baron, Todd H.

Acute cholecystitis affects ∼200,000 individuals annually in the United States, with laparoscopic cholecystectomy as the gold standard treatment. However, in high-risk surgical candidates, alternative drainage methods are necessary. Percutaneous transhepatic gallbladder drainage (PT-GBD) has traditionally served as the primary alternative intervention, offering rapid decompression, but is limited by a negative impact on the patient’s quality of life, the risk of long-term or even permanent tube placement, adverse events, and high recurrence rates. Endoscopic approaches, such as endoscopic transpapillary gallbladder drainage (ET-GBD) and, more recently, endoscopic ultrasound-guided gallbladder drainage (EUS-GBD), have emerged as viable alternatives to PT-GBD. EUS-GBD, first introduced in 2007, offers technical and clinical outcomes comparable to PT-GBD with fewer adverse events, shorter hospital stays, and lower rates of recurrence. The introduction of lumen-apposing metal stents (LAMS) has revolutionized EUS-GBD, simplifying deployment and enabling subsequent internal gallbladder access, which allows additional interventions such as cholecystoscopy and stone removal. EUS-GBD is now supported by international guidelines, and 1 device has achieved FDA approval for the management of acute cholecystitis in nonsurgical candidates. Proper patient selection is essential, guided by multidisciplinary evaluation, with EUS-GBD contraindicated in specific scenarios such as gallbladder perforation, coagulopathy, and large-volume ascites. Technical considerations include choice of access site (transgastric versus transduodenal), stent type, and procedural route [direct (freehand) or wire-guided]. Postprocedural care and stent management remain variable and nonstandardized. Emerging data suggest that interval cholecystectomy can still be performed safely after EUS-GBD. As adoption of EUS-GBD with LAMS expands, structured training and standardization of practice are crucial to optimizing outcomes.

Objective: Review the current literature for available treatments for acute cholecystitis (AC) in nonsurgical candidates and provide guidelines for the management of these patients. Background: Cholecystectomy is the gold-standard treatment modality for AC. A considerable number of patients who are not eligible for surgery are managed by percutaneous and endoscopic techniques. There is recent data regarding endoscopic ultrasound-guided gallbladder drainage and emerging percutaneous approaches to address cholelithiasis and remove drains. Methods: An expert panel of surgeons, gastroenterologists, and interventional radiologists reviewed the current literature and provided recommendations for AC management in nonsurgical candidates. Recommendations were based on relevant evidence, with quality and strength assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Results: Percutaneous cholecystostomy is advised for patients ineligible for lumen-apposing metal stent (LAMS) or with reversible conditions, aiming to bridge to cholecystectomy. The optimal timing of cholecystectomy after percutaneous cholecystostomy remains unclear. In cases where surgery is not feasible, potential definitive treatments such as percutaneous cholecystolithotripsy/lithectomy and cholecystoduodenal stenting should be considered. For calculous AC, endoscopic ultrasound-guided gallbladder drainage with LAMS is recommended as a therapy for never-surgical candidates if they are eligible for monitored anesthesia care or general anesthesia and there is institutional expertise and minimal intervening ascites. Conclusions: The management of AC in nonsurgical candidates remains a challenge, with institutional protocols varying based on physician preferences and expertise. The proposed protocol integrates percutaneous and endoscopic approaches and emphasizes the need for multidisciplinary collaboration. Further research is required to evaluate these evolving management techniques, as the current literature is limited.

AbstractEndoscopic ultrasound-guided gallbladder drainage (EUS-GBD) for symptomatic gallbladder disease has been shown to be safe and effective in patients with high surgical risk, but data are lacking for patients with cirrhosis. We investigated the safety and effectiveness of EUS-GBD in patients with and without cirrhosis.This retrospective review included patients who underwent EUS-GBD at four (three US and one Spanish) international tertiary care centers. Outcomes, including technical success, clinical success, and procedure-related adverse events, were compared between patients with and without cirrhosis.170 patients (47 with cirrhosis, 123 without cirrhosis) were included. There was no difference in age, sex, race, comorbidities, antiplatelet use, hemoglobin, or international normalized ratio between the two groups (P > 0.05 for all). The most common etiology of cirrhosis was alcohol (42.6%) with mean Model of End-stage Liver Disease-Sodium (MELD-Na) score of 16.2 (SD 8.8). Acute cholecystitis was more common in patients with cirrhosis (74.5% vs. 56.9%; P = 0.02). Technical (cirrhosis 97.9% vs. no cirrhosis 95.1%; P = 0.67) and clinical (93.6% vs. 94.9%; P = 0.71) success rates were similar in the two groups. Adverse events were infrequent and similar between groups, the most common being stent maldeployment (cirrhosis 4.3% vs. no cirrhosis 5.7%; P = 0.99). Survival rates were similar at the end of follow-up.EUS-GBD was safe and effective in patients with cirrhosis, with outcomes similar to patients without cirrhosis when performed by experienced echoendoscopists. Patients with cirrhosis and symptomatic gallbladder disease can be considered for EUS-GBD.

Abstract Background and study aims Use of fluoroscopy in gastrointestinal endoscopy is an essential aid in advanced endoscopic interventions. However, it also raises concerns about radiation exposure. This study aimed to develop consensus-based statements for safe and effective use of fluoroscopy in gastrointestinal endoscopy, prioritizing the safety and well-being of healthcare workers and patients. Methods A modified Delphi approach was employed to achieve consensus over three rounds of surveys. Proposed statements were generated in Round 1. In the second round, panelists rated potential statements on a 5-point scale, with consensus defined as ≥80% agreement. Statements were subsequently prioritized in Round 3, using a 1 (lowest priority) to 10 (highest priority) scale. Results Forty-six experts participated, consisting of 34 therapeutic endoscopists and 12 endoscopy nurses from six continents, with an overall 45.6% female representation (n = 21). Forty-three item statements were generated in the first round. Of these, 31 statements achieved consensus after the second round. These statements were categorized into General Considerations (n = 6), Education (n = 10), Pregnancy (n = 4), Family Planning (n = 2), Patient Safety (n = 4), and Staff Safety (n = 5). In the third round, accepted statements received mean priority scores ranging from 7.28 to 9.36, with 87.2% of statements rated as very high priority (mean score ≥ 9). Conclusions This study presents consensus-based statements for safe and effective use of fluoroscopy in gastrointestinal endoscopy, addressing the well-being of healthcare workers and patients. These consensus-based statements aim to mitigate risks associated with radiation exposure while maintaining benefits of fluoroscopy, ultimately promoting a culture of safety in healthcare settings.

Objective: To evaluate the safety and efficacy of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS). Background: For patients with acute cholecystitis who are poor surgical candidates, EUS-GBD using a LAMS is an important treatment alternative to percutaneous gallbladder drainage. Methods: We conducted a regulatory-compliant, prospective multicenter trial at 7 tertiary referral centers in the United States of America and Belgium. Thirty consecutive patients with mild or moderate acute cholecystitis who were not candidates for cholecystectomy were enrolled between September 2019 and August 2021. Eligible patients had a LAMS placed transmurally with 30 to 60-day indwell if removal was clinically indicated, and 30-day follow-up post-LAMS removal. Endpoints included days until acute cholecystitis resolution, reintervention rate, acute cholecystitis recurrence rate, and procedure-related adverse events (AEs). Results: Technical success was 93.3% (28/30) for LAMS placement and 100% for LAMS removal in 19 patients for whom removal was attempted. Five (16.7%) patients required reintervention. Mean time to acute cholecystitis resolution was 1.6±1.5 days. Acute cholecystitis symptoms recurred in 10.0% (3/30) after LAMS removal. Five (16.7%) patients died from unrelated causes. Procedure-related AEs were reported to the FDA in 30.0% (9/30) of patients, including one fatal event 21 days after LAMS removal; however, no AEs were causally related to the LAMS. Conclusions: For selected patients with acute cholecystitis who are at elevated surgical risk, EUS-GBD with LAMS is an alternative to percutaneous gallbladder drainage. It has high technical and clinical success, with low recurrence and an acceptable AE rate. Clinicaltrials.gov, Number: NCT03767881.

The benefit of endoscopic retrograde cholangiopancreatography (ERCP) for the treatment of primary sclerosing cholangitis (PSC) remains controversial. To identify predictors of jaundice resolution after ERCP and whether resolution is associated with improved patient outcomes, we conducted a retrospective cohort study of 124 patients with jaundice and PSC. These patients underwent endoscopic biliary balloon dilation and/or stent placement at an American tertiary center, with validation in a separate cohort of 102 patients from European centers. Jaundice resolved after ERCP in 52% of patients. Median follow‐up was 4.8 years. Independent predictors of jaundice resolution included older age (P = 0.048; odds ratio [OR], 1.03 for every 1‐year increase), shorter duration of jaundice (P = 0.059; OR, 0.59 for every 1‐year increase), lower Mayo Risk Score (MRS) (P = 0.025; OR, 0.58 for every 1‐point increase), and extrahepatic location of the most advanced biliary stricture (P = 0.011; OR, 3.13). A logistic regression model predicted jaundice resolution with area under the receiver operator characteristic curve of 0.67 (95% confidence interval, 0.5‐0.79) in the validation set. Independent predictors of death or transplant during follow‐up included higher MRS at the time of ERCP (P < 0.0001; hazard ratio [HR], 2.33 for every 1‐point increase), lower total serum bilirubin before ERCP (P = 0.031; HR, 0.91 for every 1 mg/dL increase), and persistence of jaundice after endoscopic therapy (P = 0.003; HR, 2.30). Conclusion: Resolution of jaundice after endoscopic treatment of biliary strictures is associated with longer transplant‐free survival of patients with PSC. The likelihood of resolution is affected by demographic, hepatic, and biliary variables and can be predicted using noninvasive data. These findings may refine the use of ERCP in patients with jaundice with PSC.

ABSTRACTObjectives:Pancreatitis is a known complication of endoscopic retrograde cholangiopancreatography (ERCP). Our aim was to assess the prevalence and severity of ERCP‐associated pancreatitis using established criteria.Materials and Methods:Retrospective review of patients younger than 18 years undergoing ERCP complicated by post‐ERCP pancreatitis defined by the 1991 consensus statement. Patients with chronic pancreatitis were studied separately using modified criteria. Risk factors for post‐ERCP pancreatitis were analyzed.Results:Three hundred forty‐three ERCPs were performed in 224 patients. Two hundred seventy‐six ERCPs were performed in patients without chronic pancreatitis, 7 of which were complicated by post‐ERCP pancreatitis (prevalence 2.5%). Patients undergoing diagnostic‐only ERCP were less likely to develop post‐ERCP pancreatitis (P < 0.01). Sixty‐seven procedures were performed on patients with chronic pancreatitis; 10 developed postprocedure pain requiring or prolonging hospitalization (prevalence 14.9%). Pancreatic duct stenting was a risk factor for post‐ERCP pain in this subset of patients (P = 0.02).Conclusions:The prevalence of post‐ERCP pancreatitis is low—2.5% excluding patients with chronic pancreatitis and 4.96% overall. Therapeutic procedures and the presence of chronic pancreatitis are risk factors for post‐ERCP pancreatitis.

Abstract Management bundles that define items or procedures strongly recommended in clinical practice have been used in many guidelines in recent years. Application of these bundles facilitates the adaptation of guidelines and helps improve the prognosis of target diseases. In Tokyo Guidelines 2013 ( TG 13), we proposed management bundles for acute cholangitis and cholecystitis. Here, in Tokyo Guidelines 2018 ( TG 18), we redefine the management bundles for acute cholangitis and cholecystitis. Critical parts of the bundles in TG 18 include the diagnostic process, severity assessment, transfer of patients if necessary, and therapeutic approach at each time point. Observance of these items and procedures should improve the prognosis of acute cholangitis and cholecystitis. Studies are now needed to evaluate the dissemination of these TG 18 bundles and their effectiveness. Free full articles and mobile app of TG18 are available at: http://www.jshbps.jp/modules/en/index.php?content_id=47 . Related clinical questions and references are also included.