CompletedNot Applicable

Endoscopic Sphincterotomy With Balloon Dilatation Versus Sphincterotomy Alone For Common Bile Duct Stones Removal

Malaysia66 participantsStarted 2021-06-28

Plain-language summary

Gallstone is a worldwide clinical problem which affecting most of the populations with incidence of 15 to 20% in west and 10% in Asians. About 5 to 15% of patient with gallstone will go on to develop bile duct calculi. There are several endoscopic strategies developed for treatment of common bile duct stone such as endoscopic sphincterotomy (EST), endoscopic papillary large balloon dilatation (EPLBD) and combination of EST plus EPLBD. Our aim of this study is to compare efficacy, and safety of EST alone group versus EST plus EPLBD group in removing CBD stone.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patient's age 18 and above
✓. Patient with CBD stone documented on imaging studies

Exclusion criteria

✕. CBD stone size more than 15mm
✕. CBD stone number more than 3
✕. Concurrent hepatobiliary tumour
✕. Intrahepatic stone
✕. Bleeding tendencies: coagulopathy, thrombocytopenia, patient on anticoagulant medication
✕. Patient in sepsis/ Cholangitis patient
✕. Patient with acute pancreatitis
✕. Prior history of Bilroth II or Roux-en-y surgery

What they're measuring

Rate of complete common bile stone clearance of EST alone versus EST plus EPLBD

Timeframe: 12 months

Complication rate of EST alone versus EST plus EPLBD in removing CBD stone

Timeframe: 12 months

Trial details

NCT IDNCT05638789

SponsorHospital Universiti Sains Malaysia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-27

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