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

Summary

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.

Conditions

• Cholecystectomy
• Gallbladder
• Endoscopic Ultrasound (EUS)
• Cholelithiasis
• Acute Pancreatitis Due to Common Bile Duct Calculus
• Biliary Colic
• Acute Pancreatitis Due to Gallstones
• Cholangitis; Choledocholithiasis

Interventions

PROCEDURE

EUS-guided gallbladder drainage (EUS-GBD)

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.

OTHER

Conservative management (CM)

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).

Sponsors & Collaborators

• Hospital Mutua de Terrassa

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2029-07-01

Completion

2029-07-01