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

NCT07002619 | Recruiting DMC

• 1 other identifier: COGNAC
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystolithiasis; Common Bile Duct Gall Stones

Keywords

Cholecystectomy; Intraoperative cholangiography

Outcome Measures

Primary Outcomes (1)

• Reintervention within 12 months

  Readmission and/or any type of surgical, endoscopic or radiological reintervention (corresponding to Clavien-Dindo grade 3a or higher), related to the cholecystectomy within 12 months after the cholecystectomy

  12 months

Secondary Outcomes (4)

• Procedure time

  12 hours

• Mortality

  One year

• Hospital stay

  One year

• Health-related quality of life

  Six months after surgery

Study Arms (2)

Routine cholangiography

ACTIVE COMPARATOR

Intraoperative cholangiography attempted, regardless of anatomy and indication

Procedure: Routine cholangiography

Selective cholangiography

ACTIVE COMPARATOR

Intraoperative cholangiography attempted only in case of uncertainty regarding anatomy

Procedure: Selective cholangiograpy

Interventions

Routine cholangiography PROCEDURE

Intraoperative cholangiography attempted regardless of indication and anatomy

Routine cholangiography

Selective cholangiograpy PROCEDURE

Intraoperative cholangiography only attempted in case of uncertainty regarding anatomy

Selective cholangiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing cholecystectomy

You may not qualify if:

• Preoperative suspicion of common bile duct stone
• Pregnancy
• Age \<18 years
• Preoperative suspicion of malignancy in the gallbladder or bile ducts

Sponsors & Collaborators

• Karolinska Institutet: lead
• Research department, Ersta Hospital: collaborator
• Södersjukhuset (Stockholm South General Hospital): collaborator

Study Sites (1)

Ersta Hospital

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Cholecystolithiasis; Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Camilla Runfors, MD, PhD

  Ersta Diakoni

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Sandblom, Associate Professor

CONTACT

+46704158218; gabriel.sandblom@ki.se

Camilla Runfors, MD, PhD

CONTACT

+46707405331; Camilla.runfors@erstadiakoni.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 3, 2025
• Study Start: May 1, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2025-05-25 - 2035-05-24
• Access Criteria: All information will be available by request to the principal investigator

Locations

SE (1)