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Search / Trial NCT07002619

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

Cholecystectomy Intraoperative Cholangiography

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.

Locations

Stockholm, , Sweden

Patients applied

0 patients applied

Trial Officials

Camilla Runfors, MD, PhD

Principal Investigator

Ersta Diakoni

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported