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 range18 Years

SexALL

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

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