Effect of Endoscopic Papillary Large Balloon Dilation on Recurrent Rate of Patients With Recurren… (NCT02330601) | Clinical Trial Compass
CompletedNot Applicable
Effect of Endoscopic Papillary Large Balloon Dilation on Recurrent Rate of Patients With Recurrentstones in Bile Duct
China180 participantsStarted 2014-06-01
Plain-language summary
The recurrent rate of CBDS in patients with recurrent CBDS is high. It was reported that up to 60% of patients had stone recurrence within two years after stone retrieval by ERCP. Although EPLBD is useful for for extraction of large CBDS with less operation time and mechanical lithotripsy.It is not known whether EPLBD could prevent the recurrence in patients with recurrent CBDS.Although Harada et al found that EPLBD might reduce the short-term recurrence of CBD stones in patients with previous ES. It is a retrospective study with a small sample size (n=94).
Here a prospective, randomized controlled study including two tertiary centers was designed. The aim of this study was to investigate whether EPLBD could reduce the recurrence rate in patients with recurrent CBDS.
Who can participate
Age range
18 Years – 80 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
. Age 18-80
. Patients with recurrent CBDS after ERCP
Exclusion criteria
. Benign or malignant CBD stricture
. Recurrent stone within 3 months after ERCP
. Previous endoscopic papillary large balloon dilation (EPLBD)
. Prior surgery of Bismuth II and Roux-en-Y
. Septic shock
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
1
Recurrent rate of CBDS within two years after ERCP
Timeframe: up to 2 years
Trial details
NCT IDNCT02330601
SponsorAir Force Military Medical University, China