A prospective, randomized, controlled trial to compare the effectiveness of endoscopic sphincterotomy with endoscopic papillary large balloon dilation for removal of bile duct stones

A prospective, randomized, controlled trial to compare the effectiveness of endoscopic sphincterotomy with endoscopic papillary large balloon dilation for removal of bile duct stones - EST vs EPLBD for removal of bile ductal stones

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013887

Enrollment

Registered

2014-05-08

Start date

2014-05-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bile duct stones, ductal stones

Interventions

EST group 30 cases 5/8/2014-5/7/2015 EPLBD group 30 cases 5/8/2014-5/7/2015

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. A minor diameter of stone is larger than 10 mm. 2. Patients in whom papilla of Vater have not been treated endoscopically or surgically. 3. In emergent cases, patients in whom underwent EST or EBD within a week. 4. Patients in whom CT is performed before endoscopic procedures. 5. Patients in whom written informed consent is obtained.

Exclusion criteria

Exclusion criteria: 1. Patients who underwent reconstruction of upper digestive tract(Bil II or RY) 2. Patients who underwent EST or EPBD previously. 3. Performance status is 4. 4. ASA physical status is more than 3. 5. Patients who undergo hemodaialysis. 6. Judged as inadequate for this study by the investigator. 7. Patients who become serious after first procedure.

Design outcomes

Primary

Measure	Time frame
1) total time for removal of bile duct stones 2) total sessions of ERCP	—

Secondary

Measure	Time frame
1)early and late complication rates 2)recurrence rate	—

Countries

Japan

Contacts

Public ContactKazuhide Higuchi

Osaka Medical College 2nd department of internal medicine

higuchi@poh.osaka-med.ac.jp072-683-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026