Endoscopic vs Non-endoscopic Drainage for Benign Gallbladder Diseases in High-risk Patients or Patients Desiring Gallbladder Preservation
Starting soon
Conditions studied: Gallbladder Diseases, Cholecystitis, Acute, Cholelithiasis
In brief
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.
Key facts
- Study ID
- NCT07649811
- Run by
- Air Force Military Medical University, China
- People needed
- 220
- Starts
- 2026-07-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-06-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Xijing Hospital of Digestive Diseases — Xi'an, Shaanxi, China
Full record on ClinicalTrials.gov
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