Endoscopic vs Non-endoscopic Drainage for Benign Gallbladder Diseases in High-risk Patients or Patients Desiring Gallbladder Preservation

NCT07649811 | Not Yet Recruiting DMC

• 1 other identifier: XJLL-KY-20262123
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Common gallbladder conditions like gallstones, polyps, and gallbladder inflammation are typically treated by surgically removing the gallbladder. However, surgery may be too risky for elderly patients or those with severe medical conditions, and some patients strongly prefer to keep their gallbladder. Newer, less-invasive endoscopic treatments can drain the gallbladder to treat inflammation without surgery. However, after successful drainage, doctors currently do not know whether it is better to leave a stent inside for long-term drainage or to actively remove the gallbladder stones using an endoscope. This multicenter study will follow patients in a real-world setting to compare these two approaches: the endoscopic treatment group (stone removal after drainage) and the non-endoscopic treatment group (long-term drainage alone). The goal is to evaluate which method is safer and more effective over the long term, helping doctors make better clinical decisions and improve patients' quality of life.

Conditions

Gallbladder Diseases; Cholecystitis, Acute; Cholelithiasis

Keywords

EUS-GBD; ET-GBD; PT-GBD; Gallbladder Preservation; High Surgical Risk; Endoscopic Drainage

Outcome Measures

Primary Outcomes (1)

• Incidence of Overall Adverse Events

  Adverse events related to the drainage procedure and subsequent treatments, including but not limited to bleeding, infection, bile leak, pancreatitis, and stent-related complications.

  Up to 1 year after the initial drainage procedure

Secondary Outcomes (11)

• Rate of technical success for EUS-GBD

  During the procedure

• Rate of technical success for PT-GBD

  During the procedure

• Rate of technical success for ETGBD

  During the procedure

• Clinical success

  Within 3 days (72 hours) postoperatively

• Unplanned re-interventions within 1 year postoperatively

  At 72 hours, 14 days, 30 days, 90 days, 6 months, and 1 year postoperatively

Study Arms (2)

Endoscopic Treatment Group

Procedure: Endoscopic Gallbladder Drainage

Non-endoscopic Treatment Group

Procedure: Percutaneous Gallbladder Drainage

Interventions

Percutaneous Gallbladder Drainage PROCEDURE

Traditional non-endoscopic, percutaneous transhepatic drainage of the gallbladder, typically involving long-term passive drainage.

Non-endoscopic Treatment Group

Endoscopic Gallbladder Drainage PROCEDURE

Minimally invasive drainage of the gallbladder using endoscopic techniques, which may be followed by elective transoral stone removal.

Also known as: EUS-GBD, ET-GBD

Endoscopic Treatment Group

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

high-risk acute cholecystitis patients ineligible for surgery, or patients with benign gallbladder diseases who have a strong preference and clinical requirement for gallbladder-preserving therapy

You may qualify if:

• Age ≥ 18 years, and voluntarily signed the informed consent form;
• Radiologically confirmed symptomatic benign gallbladder disease (symptomatic gallbladder stones, gallbladder polyps meeting surgical indications, acute cholecystitis TG18 Grade I/II); and meeting any of the following specific population criteria:
• High-risk surgical patients: ASA classification ≥ III, or presence of severe comorbidities that significantly increase the risk of laparoscopic cholecystectomy (LC);
• Patients with concomitant common bile duct stones (CBDS) and a strong desire for gallbladder preservation: presence of CBDS confirmed by MRCP/ERCP examination, and still strongly requesting the preservation of gallbladder function after being fully informed.

You may not qualify if:

• Suspected or confirmed gallbladder malignancy;
• Complications requiring emergency surgical intervention (gangrene, perforation, diffuse peritonitis);
• Uncorrectable severe coagulation dysfunction;
• Presence of severe anatomical deformity or obstruction of the stomach, duodenum, or esophagus, where the endoscope is expected to be unable to reach the target site (papilla or pericholecystic area);
• Significant gallbladder atrophy (longitudinal diameter \< 4 cm or anteroposterior diameter \< 2 cm);
• Pregnant or lactating women;
• Previous history of cholecystectomy;
• Presence of psychiatric disorders or any condition that prevents cooperation with treatment and follow-up;
• Unwilling or unable to sign the informed consent form.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710000, China

Location

MeSH Terms

Conditions

Gallbladder Diseases; Cholecystitis, Acute; Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Cholecystitis

Central Study Contacts

Yanglin Pan

CONTACT

+86 13991811225; yanglinpan@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

CN (1)