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

NCT07575360 | Completed

• 1 other identifier: 233-2024-OSS-AUSLIM
• Study Type: observational
• Target: 484
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholecystitis, Acute

Keywords

PT-GBD; EUS-GBD; LAMS; ERCP; Conversion; Cholecystostomy

Outcome Measures

Primary Outcomes (1)

• Recurrent acute cholecystitis

  Any clinical, biochemical or radiological recurrence of acute cholecystitis, defined according to Tokyo guidelines 2018 criteria

  12-month

Secondary Outcomes (5)

• Biliary reintervention

  12-month

• Biliary-related mortality

  12-month

• Overall mortality

  12-month

• Readmission

  12-month

• Technical success

  Periprocedural

Study Arms (2)

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

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)

Interventions

EUS-GUIDED INTERNALIZATION OF PERCUTANEOUS CHOLECYSTOSTOMY (EPIC-GBD) PROCEDURE

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.

EUS-GUIDED INTERNALIZATION OF PERCUTANEOUS CHOLECYSTOSTOMY (EPIC-GBD)

Standard cholecystostomy (PT-GBD) management PROCEDURE

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.

Standard cholecystostomy (PT-GBD) management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Gastroenterology Unit, Hospital of Imola

Imola, 40026, Italy

Location

Related Publications (3)

• 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.

  PMID: 26528802 BACKGROUND

• 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.

  PMID: 30039611 BACKGROUND

• 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.

  PMID: 32165407 BACKGROUND

MeSH Terms

Conditions

Cholecystitis, Acute

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Pietro Fusaroli, Professor

  University of Bologna, Hospital of Imola

  STUDY DIRECTOR

• Andrea Lisotti, MD

  Hospital of Imola

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 8, 2026
• Study Start: April 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)