MedTrace Logo

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

NCT07002619 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6000

Last updated 2025-06-03

No results posted yet for this study

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

Interventions

PROCEDURE

Routine cholangiography

Intraoperative cholangiography attempted regardless of indication and anatomy

PROCEDURE

Selective cholangiograpy

Intraoperative cholangiography only attempted in case of uncertainty regarding anatomy

Sponsors & Collaborators

  • Research department, Ersta Hospital

    collaborator UNKNOWN

  • Södersjukhuset (Stockholm South General Hospital)

    collaborator UNKNOWN

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Camilla Runfors, MD, PhD · Ersta Diakoni

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07002619 on ClinicalTrials.gov