ChOlanGiography Performed Routinely Versus Selectively During Cholecystectomy: A NAtional Registry-based Randomized Controlled Trial
Launched by KAROLINSKA INSTITUTET · May 25, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at whether a special procedure called intraoperative cholangiography (IOC) should be performed routinely during gallbladder surgery to check for common bile duct stones (CBDS), or if it can be done only when there is a suspicion of these stones. CBDS can sometimes lead to serious problems, but the procedure to find and remove them can also cause complications. The study aims to understand the risks of both approaches by comparing outcomes in about 6,000 patients undergoing gallbladder surgery without any preoperative suspicion of CBDS.
To participate in this trial, individuals need to be between 18 and 74 years old and scheduled for gallbladder surgery. Those who are pregnant, have a suspicion of bile duct stones, or have certain other medical conditions will not be included. Participants can expect to be randomly assigned to either have the IOC procedure during their surgery or not, and they will be monitored for any complications related to the surgery for up to one year. The results of this trial could help improve gallbladder surgery practices not just in Sweden but worldwide.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients undergoing cholecystectomy
- Exclusion Criteria:
- • Preoperative suspicion of common bile duct stone
- • Pregnancy
- • Age \<18 years
- • Preoperative suspicion of malignancy in the gallbladder or bile ducts
About Karolinska Institutet
Karolinska Institutet is a renowned medical university located in Sweden, recognized for its commitment to advancing healthcare through innovative research and education. As a leading sponsor of clinical trials, the institution focuses on translating scientific discoveries into effective treatments and therapies, emphasizing patient-centered approaches. With a strong emphasis on collaboration and interdisciplinary research, Karolinska Institutet plays a pivotal role in addressing global health challenges and improving patient outcomes, leveraging its extensive network of experts and state-of-the-art facilities to drive clinical advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Stockholm, , Sweden
Patients applied
Trial Officials
Camilla Runfors, MD, PhD
Principal Investigator
Ersta Diakoni
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported