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NCT07575360

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

Sponsor: University of Bologna

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

484

Start Date

2024-04-01

Completion Date

2025-09-30

Last Updated

2026-05-08

Healthy Volunteers

No

Interventions

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.

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.

Locations (1)

Gastroenterology Unit, Hospital of Imola

Imola, Italy