UnknownNot Applicable

Long-duration EPBD vs EST for Removal of Biliary Stones

South Korea358 participantsStarted 2018-04-01

Plain-language 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.

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: * Consecutive patients were invited to participate by the investigators or research staff if they were at least 18 years old, * patients who had known or suspected choledocholithiasis Exclusion Criteria: * active acute pancreatitis * septic shock, * coagulopathy (international normalized ratio \>1.2, partial thromboplastic time greater than twice that of control), * platelet count \<50,000 x 103/uL, * anticoagulation therapy within 48 hours of the procedure, * stone diameter \> 8 mm, * bile duct diameter \>15 mm, prior sphincterotomy, * need for precut sphincterotomy for biliary access, * biliary stricture, * Billroth II or Roux-en-Y anatomy, * periampullary malignancies, * primary sclerosing cholangitis, pregnancy, * and inability to give informed consent

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

rate of adverse event

Timeframe: up to 1 month after ERCP

Trial details

NCT IDNCT03683485

SponsorDankook University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-01

Contact for this trial

Jun Ho Choi, MD, PhD

82-41-550-7631 mdcjh78@gmail.com

View on ClinicalTrials.gov More Cholangiopancreatography, Endoscopic Retrograde trials