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RECRUITING
NCT05702775
NA

Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Inoperable Acute Cholecystitis

Sponsor: Fundacion Miguel Servet

View on ClinicalTrials.gov

Summary

In this project the investigators propose to carry out a clinical trial that compares non-endoscopic treatment of cholecystitis with antibiotics versus endoscopic drainage in non-operable acute cholecystitism (AC), especially focused on the rate of subsequent EBP and recurrence of AC, as well as the impact on the quality of life, also exploring the costs. The ultimate goal of this project is to generate knowledge and scientific evidence that makes it easier for health professionals to choose the most appropriate strategy for non-operable patients with lithiasic AC. Ourworking hypothesis is that endoscopic treatment (EUS-GBD) will significantly reduce the number of EBP compared to non-endoscopic treatment in patients with non-operable lithiasic AC.

Official title: Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Patients With Inoperable Acute Cholecystitis: a Multicenter Randomized Clinical Trial (EUS-DRAIN)

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2022-10-01

Completion Date

2026-07-01

Last Updated

2023-01-27

Healthy Volunteers

No

Interventions

PROCEDURE

Endoscopic treatment group (EUS-GBD group

The placement of a endoscopic drain performed using a linear echoendoscope that allows the gallbladder to be punctured from the gastric antrum or the duodenal bulb to generate a cholecystogastrostomy or a cholecystoduodenostomy, respectively. Transmural gallbladder drainage will be performed by placing a metal apposition stent (LAMS) with the 15x15mm Hot AXIOS device (Boston Scientific) in the case of cholecystogastrostomy or 15x10 or 10x10mm in the case of cholecystoduodenostomy. Subsequently, the interior of the gallbladder will be irrigated with saline solution until the vesicular content comes out.

Locations (1)

Hospital Universitario de Navarra

Pamplona, Navarre, Spain