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Long-duration EPBD vs EST for Removal of Biliary Stones

NCT03683485 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2018-10-01

No results posted yet for this study

Summary

Although EPBD has a lower risk of post-ERCP bleeding and long-term complications than EST and is easier to perform in altered/difficult anatomy, EPBD is reserved for patients with bleeding diathesis by current consensus because some studies reported a higher risk of pancreatitis. However, recent meta-analyses indicate that short EPBD duration increases the risk of post-ERCP pancreatitis, and EPBD with adequate duration has a similar pancreatitis risk and a lower overall complication rate compared with EST for choledocholithiasis.

Therefore, this study aim to compare long-duration EPBD vs EST in the treatment of extrahepatic biliary stones.

Conditions

  • Cholangiopancreatography, Endoscopic Retrograde

Interventions

PROCEDURE

long duration EPBD

An 8-mm dilatation balloon was used for EPBD. Balloons were gradually inflated to maximum pressure for 3 minute, and complete inflation was verified by fluoroscopy.

PROCEDURE

EST

After deep cannulation was achieved, a complete sphincterotomy was performed with a 25-mm pull-type sphincterotome (Clever Cut 3; KD-V411M, Olympus, Tokyo, Japan) and the sphincter was divided up to the transverse duodenal fold.

Sponsors & Collaborators

  • Inje University

    collaborator OTHER

  • The Catholic University of Korea

    collaborator OTHER

  • Wonkwang University

    collaborator OTHER

  • Dankook University

    lead OTHER

Principal Investigators

  • Jun Ho Choi, MD, PhD · Dankook University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2019-05-01
Completion
2021-08-01

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03683485 on ClinicalTrials.gov