NCT07002619 ChOlanGiography Performed Routinely Versus Selectively During Cholecystectomy: A NAtional Registry-based Randomized Controlled Trial
| NCT ID | NCT07002619 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Cholecystolithiasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 6,000 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6,000 participants in total. It began in 2023-05-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Common bile duct stones (CBDS) may be asymptomatic but can cause pancreatitis, obstructive jaundice, and/or cholangitis. In Sweden, intraoperative cholangiography (IOC) is usually performed during gallstone surgery in order to detect CBDS and proactively extract them. The intervention to extract them may, however, cause complications by itself such as pancreatitis, bleeding, or perforation. In many countries, IOC is performed selectively when CBDS are suspected preoperatively (by patient history, imaging, or blood tests), or if the anatomy is unclear. There is a knowledge gap regarding the relation between risks associated with refraining from IOC and, thus, leaving undetected CBDS in situ, or actively diagnosing and removing the stones. To compare these risks, we propose a national multicenter randomized controlled trial. The study will be embedded in the Swedish Registry for Gallstone Surgery (GallRiks), which will include all variables for inclusion and follow-up. Population: Patients undergoing gallstone surgery without suspicion of CBDS Intervention: IOC Control: No IOC Outcome: Readmission or reintervention (Clavien-Dindo grade ≥IIIa) related to the cholecystectomy within 12 months after the operation. A total of 6000 patients will be recruited. The results will have the potential to provide level A evidence for routines used in gallstone surgery not only in Sweden, but also internationally.
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
Contact & Investigator
Camilla Runfors, MD, PhD
PRINCIPAL INVESTIGATOR
Ersta Diakoni
Frequently Asked Questions
Who can join the NCT07002619 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cholecystolithiasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07002619 currently recruiting?
Yes, NCT07002619 is actively recruiting participants. Contact the research team at gabriel.sandblom@ki.se for enrollment information.
Where is the NCT07002619 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT07002619 clinical trial?
NCT07002619 is sponsored by Karolinska Institutet. The principal investigator is Camilla Runfors, MD, PhD at Ersta Diakoni. The trial plans to enroll 6,000 participants.