Effect of Saline Irrigation to DEcrease Rate Of Residual Common Bile Duct Stones (NCT01425177) | Clinical Trial Compass
UnknownPhase 3
Effect of Saline Irrigation to DEcrease Rate Of Residual Common Bile Duct Stones
South Korea160 participantsStarted 2011-08
Plain-language summary
In recent years, endoscopic sphincterotomy and stone extraction are standard procedures for the removal of bile duct stones.
After procedures, there are some complications such as stone recurrence, papillary stenosis, cholangitis and liver abscess. These recurrent symptomatic bile duct stones, despite increasing experience and success with the procedure, occur in 4% to 24% of patients.
Gallbladder stone, pneumobilia and many other various factors are known to be associated with CBD stone recurrence. Lithotripsy was also related to the development of recurrent stones. It is natural that small stone fragments left after lithotripsy may act as nidi for stone recurrence.
Small remaining stone could not be completely detected only using ERCP stone removal and remaining stone removal can reduce residual and recurrent stones. Saline irrigation was effective immediately after ERCP stone removal to remove remaining small stones.
Saline irrigation has many advantages such as easy to treatment during ERCP stone removal, almost no additional cost and rare side effect. This study The authors expect this study is a remarkable role of ERCP stone removal procedure.
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:
* The patients were treated with CBD stone removal during therapeutic ERCP after finding CBD stones with CT, ultrasound or MRCP.
* The patients were treated with CBD stone removal during diagnostic ERCP because of cholangitis or cholecystitis.
Exclusion Criteria:
* Hemodynamic instability
* Younger than 18
* Mental illness
* Received previous CBD stone removal
* Hemolytic anemia, IHD stone, parasites in hepatobiliary system
* Genetic, autoimmune, congenital biliary disorder
* Liver or biliary surgery except cholecystectomy
* Pancreatic cancer, cholangiocarcinoma, ampulla of vater cancer
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.
1This trial is specifically looking at whether saline irrigation can reduce leftover stones in the common bile duct after a procedure — is that a real concern for my situation, and how often do retained stones actually cause problems if they're not all removed?
2Since this is a Phase 3 trial, it's testing saline irrigation in a larger group to confirm earlier findings — can you tell me what the earlier research showed about safety and effectiveness before I consider whether this approach might be relevant to my care?
3The recruitment status for this trial is listed as 'unknown,' which might mean it's no longer actively enrolling — do you know if this study is still open, and if not, are there similar or more current studies I should be aware of?
4Compared to whatever standard procedure you'd normally use to clear my common bile duct, what would be different about my experience if saline irrigation were added, and would it make the procedure longer or more complicated?
5If retained stones are a risk after my procedure regardless of this trial, what symptoms should I watch for afterward, and what's the usual next step if a stone is found to have been missed?
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.