EUS-Guided Gallbladder Drainage Versus Conservative Management in Patients Unfit for Surgery After a Biliary Event Without Cholecystitis. DRECON Study

N/ANot Yet RecruitingNCT07655778

Hospital Mutua de Terrassa110 enrolled

Overview

Cholecystectomy is considered the standard definitive treatment after an acute biliary event (biliary colic, acute pancreatitis, cholangitis, or choledocholithiasis). However, in elderly patients and/or those with significant comorbidities, surgery is often not feasible, leaving this population at high risk of biliary event recurrence (approximately 25-31% per year without treatment). EUS-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS) is an established endoscopic technique currently recommended for acute cholecystitis in patients unfit for surgery. It creates an internal fistula between the gallbladder and the adjacent digestive tract, allowing direct endoscopic access for stone clearance (cholecystoscopy). This approach could theoretically prevent biliary event recurrence similarly to cholecystectomy. The DRECON study (DRainaige, Endoscopic ultrasound, CONservative) is a multicenter, randomized, comparative clinical trial evaluating whether EUS-GBD with LAMS reduces biliary recurrence at 1 year compared to conservative managment (CM) in patients unfit for surgery after a biliary event without acute cholecystitis who are candidates for elective cholecystectomy. Primary hypothesis: EUS-GBD will reduce the risk of biliary event recurrence (biliary colic, acute pancreatitis, cholangitis, choledocholithiasis, or cholecystitis) at 1 year of follow-up compared to conservative management in patients unfit for surgery with gallbladder lithiasis. Estimated sample: 110 patients (55 per arm). Randomization 1:1 (EUS-GBD vs CM), stratified by centre and prior biliary sphincterotomy. Duration: 24 months recruitment + 12 months follow-up (total 3 years). Participating centres: Hospital Universitari Mútua de Terrassa (coordinating centre), Hospital Universitari de Bellvitge, Hospital General de Granollers, Hospital Universitari Parc Taulí de Sabadell, Hospital Universitari de la Santa Creu i Sant Pau, Hospital Clínico Universitario de Valencia, Hospital General Universitario Dr Balmis and Complexo Hospitalario Universitario de A Coruña.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Interventions

EUS-guided gallbladder drainage (EUS-GBD)PROCEDURE

Endoscopic procedure under CO2 insufflation using a therapeutic linear echoendoscope (therapeutic channel \>3.7 mm). A cholecystogastrostomy or cholecystoduodenostomy is created by deploying a LAMS between the gallbladder and the gastric antrum or duodenal bulb (operator's choice). A coaxial double-pigtail plastic stent (7Fr, 3-5 cm) is placed through the LAMS.

Conservative management (CM)OTHER

Standard supportive medical care will be determined by the treating medical team according to clinical evolution (analgesia, fluid support, antibiotic therapy, etc.). Patients with lithogenic material in the extrahepatic bile duct confirmed by imaging or EUS will undergo endoscopic retrograde cholangiopancreatography (ERCP).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients ≥ 18 years of age * Patients who have experienced a benign biliary event (biliary colic, acute pancreatitis, cholangitis, or choledocholithiasis) and are candidates for elective cholecystectomy * Patients deemed unfuit for surgery (age ≥ 80 years, ASA score ≥ 3, Charlson Comorbidity Index ≥ 5) or who voluntarily refuse surgery * Diagnosis of lithogenic/lithiasic material in the gallbladder by imaging (biliary sludge, microlithiasis, and/or cholelithiasis) * Signed informed consent Exclusion Criteria: * No signed informed consent * Prior cholecystectomy * Biliary event secondary to malignant etiology * Acute cholecystitis diagnosed according to Tokyo 2018 criteria * Moderate-to-severe ascites without prior paracentesis * Perforated gallbladder * Severe coagulopathy (INR \> 1.5) or thrombocytopenia (platelets \< 50,000/μL) not correctable * Any clinical condition preventing sedation * Patient dependent for daily activities (ECOG ≥ 4)

Outcomes

Primary Outcomes

Clinical biliary recurrence rate at 1-year follow-up

Percentage of patients presenting a new biliary event (biliary colic, acute pancreatitis, cholangitis, choledocholithiasis, or cholecystitis) defined according to Tokyo 2018 guidelines and revised Atlanta 2012 criteria.

Time frame: 12 months after procedure (in experimental Arm 1- EUS-GBD) or randomization (in case of Arm 2 - CM)