ChOlanGiography Performed Routinely Versus Selectively During Cholecystectomy: A NAtional Registry-based Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients undergoing cholecystectomy

Locations
Other Locations
Sweden
Ersta Hospital
RECRUITING
Stockholm
Contact Information
Primary
Gabriel Sandblom, Associate Professor
gabriel.sandblom@ki.se
+46704158218
Backup
Camilla Runfors, MD, PhD
Camilla.runfors@erstadiakoni.se
+46707405331
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2028-12
Participants
Target number of participants: 6000
Treatments
Active_comparator: Routine cholangiography
Intraoperative cholangiography attempted, regardless of anatomy and indication
Active_comparator: Selective cholangiography
Intraoperative cholangiography attempted only in case of uncertainty regarding anatomy
Sponsors
Collaborators: Södersjukhuset (Stockholm South General Hospital), Research department, Ersta Hospital
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov