CompletedNot Applicable

Laparoscopic Endobiliary Stent and Postoperative ERCP Compared to Intraoperative ERCP

Sweden1,200 participantsStarted 2024-03-20

Plain-language summary

Laparoscopic endobiliary stent and postponed endoscopic retrograde cholangiopancreatography, ERCP, compared to intraoperative ERCP for the treatment of common bile duct stones, CBDS, a retrospective registry based cohort study. Data will be collected from GallRiks, the Swedish national registry for cholecystectomies and ERCP. Patients in the registry identified with found of CBDS at intraoperative cholangiography, IOC, and there after treated with ERCP during 2010-01-01 to 2023-12-31 are the study population. Research question: In patients with intraoperatively diagnosed CBDS - is there a difference in complications between laparoparoscopic endobiliary stent with postoperative ERCP, and intraoperative ERCP? Primary outcome: Complications within 30 days after cholecystectomy and the following ERCP. Secondary outcomes: 30 day mortality, procedure time for cholecystectomy, procedure time for ERCP, difficult cannulation, stone clearance at ERCP, cumulative hospital stay, readmission within 30 days after cholecystectomy/ERCP

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: Laparoscopic choleystectomy with intraoperative found of common bile duct stones by intraoperative cholangiography. Common bile duct treated with laparoscopic endobiliary stent and postponed ERCP or intraoperative ERCP Exclusion Criteria: Other types of treatment for common bile duct stones Conversion to or open cholecystectomy \-

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

Complication after cholecystectomy and the following ERCP

Timeframe: 30 days after each procedure

Trial details

NCT IDNCT06817291

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-11-11

View on ClinicalTrials.gov More Common Bile Duct Stones trials