Gallstone showdown: which treatment wins?

NCT ID NCT07413068

Disease control Sponsor: Qilu Hospital of Shandong University Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares three approaches for people with both gallstones and bile duct stones: a gallbladder-preserving procedure using an endoscope, ERCP plus gallbladder removal surgery, or conservative management with medication or watchful waiting. Researchers will track complications and success rates in 300 participants to see which option is safest and most effective. The goal is to help patients and doctors choose the best treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: ursodeoxycholic acid
What this could lead to: If successful, this could show which treatment option is safest and most effective for people with both gallstones and bile duct stones, helping guide future care.
What could go wrong: This is an observational study based on patient preference, not random assignment, so results may be less reliable. It is also early-stage and may not lead to clear conclusions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

patients with cholelithiasis with concomitant choledocholithiasis

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Patients over the age of 18 years; 2. Ultrasound, MRCP, or other imaging examination findings (CT/MRI) clearly indicate a diagnosis of cholelithiasis with concomitant choledocholithiasis; 3. Patients with no history of gastrointestinal reconstruction surgery or cholecystectomy or previous biliary tract surgery (include history of ERCP); 4. Patients with every gallbladder stone ≤1 cm in diameter or sludge-like stones; 5. The morphology and size of the gallbladder are essentially normal and the thickness of the gallbladder wall is ≤3 mm; 6. Voluntary provision of signed informed consent. Exclusion Criteria 1. Atrophic cholecystitis; porcelain gallbladder; suspect malignant tumor of the gallbladder; stenosis of the lower segment of the common bile duct; Mirrizzi syndrome; 2. Unable to undergo endoscopic interventions for various reasons; 3. Absolute surgical contraindications, including severe hepatic, renal, cardiac and pulmonary insufficiency, history of cerebral coma and allergy to anesthesia, etc; 4. Presence of ectopic duodenal papilla or congenital pancreaticobiliary malformation; 5. Patients with severe coagulopathy, defined as an International Normalized Ratio (INR) \> 1.5 or patients with significant thrombocytopenia (platelet count \< 50 × 10⁹/L); 6. Pregnant women;

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Conditions

The condition(s) this trial relates to.

choledocholithiasis cholelithiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cholelithiasis associated with common bile duct stones

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Gallstone showdown: which treatment wins?

What the study statuses mean