CompletedNot Applicable

Endoscopic Papillary Large Balloon Dilatation Versus Mechanical Lithotripsy for Large Stones

Thailand85 participantsStarted 2010-12

Plain-language summary

Endoscopic sphincterotomy (EST) combined with large balloon dilation (LBD) has been increasingly accepted as alternative method for removal of large bile duct stones. However, there were limited studies comparing the efficacy of EST in combined with LBD to EST with mechanical lithotripsy (ML). The purpose of this study to compare the efficacy and safety of combined EST- LBD versus EST-ML in the removal of very large bile duct stones.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: -Patients with age\>/= 18 years with confirmed or suspected CBDS at our institute were enrolled in the study. * Informed consent was obtained in every patients prior to the procedure * Patients were randomized to LBD or ML if they had CBD stone \>/= 15 mm in shortest dimension or stone' size was disproportionate to the lower bile duct segment with a ratio of largest stone dimension/lower bile duct segment diameter \> 50 % identified by a cholangiogram at ERCP. Exclusion Criteria:-pregnant woman * uncorrectable coagulopathy (INR \>1.5 ), thrombocytopenia( platelet count \< 50,000) * concomitant intrahepatic duct stones * ongoing acute pancreatitis or acute cholecystitis * surgically altered anatomy (i.e. Billroth II or Roux-en-Y reconstruction) * concomitant pancreatic or biliary malignancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complete stone clearance rate in the index ERCP

Timeframe: 24 hours

Trial details

NCT IDNCT02666820

SponsorPrince of Songkla University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-05

View on ClinicalTrials.gov More Common Bile Duct Stones trials