PT-GBD to EUS-GBD Conversion Versus Standard Management in High-Risk Acute Cholecystitis Patients (EPIC-GBD)

Conversion to Endoscopic Ultrasound-Guided Gallbladder Drainage (EUS-GBD) Versus Standard Management of High-Risk Surgical Patients Who Underwent Percutaneous Trans-Hepatic Gallbladder Drainage (PT-GBD) for Acute Cholecystitis

Acute cholecystitis in high-risk surgical patients is commonly managed with percutaneous trans-hepatic gallbladder drainage (PT-GBD). However, long-term adverse events, tube dysfunction, and recurrent cholecystitis remain significant concerns. This retrospective multicenter observational study compares long-term outcomes of conversion from PT-GBD to endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with lumen-apposing metal stents (LAMS) versus standard management in high-risk surgical patients with acute cholecystitis.

Study Overview

• Status: Completed
• Conditions: Cholecystitis, Acute
• Intervention / Treatment: Procedure: Standard cholecystostomy (PT-GBD) management; Procedure: EUS-GUIDED INTERNALIZATION OF PERCUTANEOUS CHOLECYSTOSTOMY (EPIC-GBD)

Detailed Description

Acute cholecystitis is a common and potentially severe condition that often requires timely intervention, particularly in high-risk surgical patients who are not suitable candidates for cholecystectomy. In this population, percutaneous trans-hepatic gallbladder drainage (PT-GBD) is widely used as an effective minimally invasive treatment, providing rapid clinical improvement and high technical success rates. However, despite its short-term efficacy, PT-GBD is associated with significant long-term limitations, including tube dysfunction or dislodgement, patient discomfort related to the external catheter, and a relatively high incidence of recurrent cholecystitis and other adverse events.

Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using lumen-apposing metal stents (LAMS) has emerged as an alternative minimally invasive approach that allows internalization of gallbladder drainage. This technique has the potential to improve patient quality of life, reduce catheter-related complications, and decrease the incidence of recurrent biliary events. Conversion from PT-GBD to EUS-GBD has been proposed as a strategy to overcome the limitations of long-term percutaneous drainage. Preliminary evidence suggests that such a conversion is technically feasible and associated with favorable clinical outcomes, including reduced adverse events and improved long-term management.

Nevertheless, the available literature is limited, and comparative data between conversion to EUS-GBD using LAMS and standard management after PT-GBD are scarce. In particular, only a limited number of studies have specifically evaluated outcomes following conversion with LAMS, and no large comparative studies have definitively assessed its impact on long-term adverse events and clinical outcomes.

This multicenter retrospective observational study aims to compare the long-term outcomes of two management strategies in high-risk surgical patients with acute cholecystitis who previously underwent PT-GBD: (1) conversion to EUS-GBD using LAMS and (2) standard management without conversion. All consecutive eligible patients treated with PT-GBD will be retrospectively identified and included according to predefined inclusion and exclusion criteria.

The primary objective of the study is to evaluate the incidence of adverse events at 1 year in patients undergoing PT-GBD to EUS-GBD conversion compared with those receiving standard management. Secondary objectives include the assessment of technical success, clinical success, procedural adverse events, 30-day adverse events, 1-year incidence of stent dysfunction, biliary adverse events, recurrent cholecystitis, biliary reintervention rate, readmission rate, biliary-related mortality, and overall survival.

Data will be collected from participating centers using standardized case report forms, including demographic characteristics, clinical variables, procedural details, and follow-up outcomes. Patients will be followed for at least 1 year to assess the occurrence of adverse events and other clinical endpoints.

The study is conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. Approval from the relevant Ethics Committees will be obtained at each participating center prior to data collection.

• Study Type: Observational
• Enrollment (Actual): 484

Contacts and Locations

Study Locations

• Italy
  • Imola, Italy, 40026
    • Gastroenterology Unit, Hospital of Imola

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult patients (≥18 years) with acute cholecystitis who were considered high-risk for surgery and managed with percutaneous trans-hepatic gallbladder drainage (PT-GBD). All patients were deemed unfit for cholecystectomy after multidisciplinary evaluation. Eligible patients are retrospectively identified from participating centers and include all consecutive cases undergoing PT-GBD during the study period. The population reflects a real-world cohort of frail patients with significant comorbidities. Two groups are defined based on subsequent management: conversion to endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with lumen-apposing metal stent (LAMS) versus standard management.

Description

Inclusion Criteria:

• Age >18 years
• Patients considered unfit for surgery after multidisciplinary discussion
• Patients who underwent PT-GBD for acute cholecystitis

Exclusion Criteria:

• Patients with improved general conditions who become fit for laparoscopic cholecystectomy
• Use of anticoagulants that cannot be discontinued
• Coagulation and/or platelet hereditary disorders and/or INR >1.5, PLT <50,000
• Absolute contraindication for EUS-GBD
• Post-surgical altered upper gastrointestinal anatomy
• Malignant biliary obstruction

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard cholecystostomy (PT-GBD) management; High-risk surgical patients with acute cholecystitis who underwent PT-GBD and received standard management without conversion to EUS-GBD.	Procedure: Standard cholecystostomy (PT-GBD) management; Patients in the comparator group are high-risk surgical patients with acute cholecystitis who underwent PT-GBD and continued with standard management without conversion to EUS-GBD. Standard management consists of maintenance of the percutaneous trans-hepatic gallbladder drainage catheter, including routine care, monitoring, and management according to institutional clinical practice. This may include periodic catheter exchanges, management of catheter-related complications, and clinical follow-up. In selected cases, removal of the percutaneous drain may be considered if clinically indicated, based on resolution of symptoms and treating physician judgment. However, no internal drainage via EUS-guided techniques is performed in this group.
EUS-GUIDED INTERNALIZATION OF PERCUTANEOUS CHOLECYSTOSTOMY (EPIC-GBD); High-risk surgical patients with acute cholecystitis who previously underwent PT-GBD and were subsequently converted to EUS-guided gallbladder drainage with LAMS.	Procedure: EUS-GUIDED INTERNALIZATION OF PERCUTANEOUS CHOLECYSTOSTOMY (EPIC-GBD); Patients included in the intervention group are high-risk surgical patients with acute cholecystitis who previously underwent percutaneous trans-hepatic gallbladder drainage (PT-GBD) and subsequently underwent conversion to endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS). The procedure is performed under endoscopic ultrasound (EUS) guidance using a linear echoendoscope to identify the gallbladder from the gastric or duodenal lumen. After confirming the absence of intervening vessels using Doppler imaging, the gallbladder is accessed and a LAMS delivery system is advanced to create a fistulous tract between the gallbladder and the gastrointestinal lumen (either transgastric or transduodenal approach). The LAMS is then deployed to allow internal drainage of gallbladder contents into the gastrointestinal tract.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent acute cholecystitis	Any clinical, biochemical or radiological recurrence of acute cholecystitis, defined according to Tokyo guidelines 2018 criteria	12-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biliary reintervention	Any planned or unplanned biliary reintervention (stent revision, replacement, ERCP, EUS, etc.) required during the 1-year follow-up	12-month
Biliary-related mortality	Patient's death caused by any biliary-related disease, complication or adverse event.	12-month
Overall mortality	Patient's death for any cause	12-month
Readmission	Patient's hospital admission for any cause during the follow-up period	12-month
Technical success	Adequate stent placement during internalization of cholecystostomy (limited to the intervention group)	Periprocedural

Collaborators and Investigators

• Sponsor: University of Bologna
• Investigators: Study Director: Pietro Fusaroli, Professor, University of Bologna, Hospital of Imola; Principal Investigator: Andrea Lisotti, MD, Hospital of Imola

Publications and helpful links

General Publications

• Law R, Grimm IS, Stavas JM, Baron TH. Conversion of Percutaneous Cholecystostomy to Internal Transmural Gallbladder Drainage Using an Endoscopic Ultrasound-Guided, Lumen-Apposing Metal Stent. Clin Gastroenterol Hepatol. 2016 Mar;14(3):476-80. doi: 10.1016/j.cgh.2015.10.026. Epub 2015 Oct 31.
• Minaga K, Yamashita Y, Ogura T, Takenaka M, Shimokawa Y, Hisa T, Itonaga M, Kato H, Nishikiori H, Okuda A, Matsumoto H, Uenoyama Y, Watanabe T, Chiba Y, Higuchi K, Kudo M, Kitano M. Clinical efficacy and safety of endoscopic ultrasound-guided gallbladder drainage replacement of percutaneous drainage: A multicenter retrospective study. Dig Endosc. 2019 Mar;31(2):180-187. doi: 10.1111/den.13242. Epub 2018 Aug 27.
• Teoh AYB, Kitano M, Itoi T, Perez-Miranda M, Ogura T, Chan SM, Serna-Higuera C, Omoto S, Torres-Yuste R, Tsuichiya T, Wong KT, Leung CH, Chiu PWY, Ng EKW, Lau JYW. Endosonography-guided gallbladder drainage versus percutaneous cholecystostomy in very high-risk surgical patients with acute cholecystitis: an international randomised multicentre controlled superiority trial (DRAC 1). Gut. 2020 Jun;69(6):1085-1091. doi: 10.1136/gutjnl-2019-319996. Epub 2020 Mar 12.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: May 2, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: ERCP; Conversion; LAMS; Cholecystostomy; PT-GBD; EUS-GBD
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Cholecystitis; Cholecystitis, Acute; Therapeutics
• Other Study ID Numbers: 233-2024-OSS-AUSLIM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared. The study involves retrospective data collected and data sharing is limited by institutional policies and data protection regulations. De-identified aggregate data may be made available upon reasonable request to the corresponding author, subject to approval by the study investigators and participating centers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No