ChOlanGiography Performed Routinely Versus Selectively During Cholecystectomy: A NAtional Registry-based Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 6,000
- Locations
- 1
- Primary Endpoint
- Reintervention within 12 months
Study Overview
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.
Detailed Description
ChOlanGiography performed selectively versus routinely during cholecystectomy: a NAtional registry-based randomized Controlled trial (the COGNAC trial)
Purpose and aims Cholecystectomy for symptomatic gallstone disease is one of the most common surgical procedures worldwide. Around 13 000 cholecystectomies are performed each year in Sweden (1). In addition to causing pain and inflammation of the gallbladder, gallstones may migrate through the cystic duct into the common bile duct where they can be either asymptomatic or cause complications such as biliary obstruction, cholangitis, or pancreatitis.
To diagnose common bile duct stones (CBDS), intraoperative cholangiography (IOC) can be performed during cholecystectomy. IOC also helps to verify the anatomy of the bile ducts and may, thus, reduce the risk of intraoperative bile duct injuries (2). There are several techniques available for extraction of CBDS detected at IOC, all being associated with a risk of complications such as cholangitis, pancreatitis or bleeding. Endoscopic Retrograde Cholangiopancreatography (ERCP) is the most commonly used method with reported rates of complications in 10-15% of the procedures, ranging in severity from mild to lethal (1).
Whether IOC should be performed routinely during cholecystectomy is controversial. The aim of this study is therefore to assess whether selective or routine use of IOC is superior with regards to preventing complications/morbidity after cholecystectomy.
Survey of the field There is no consensus regarding when IOC should be performed. It is uncontroversial to recommend that patients with symptoms or laboratory findings suggestive of CBDS should undergo IOC, since these could be expected to cause complications and therefore should be extracted. In addition, IOC should be performed if the anatomy of the bile ducts is unclear during the operation in order to reduce the risk of bile duct injuries.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Selective cholangiography
Intraoperative cholangiography attempted only in case of uncertainty regarding anatomy
Intervention: Selective cholangiograpy (Procedure)
Routine cholangiography
Intraoperative cholangiography attempted, regardless of anatomy and indication
Intervention: Routine cholangiography (Procedure)
Outcomes
Primary Outcomes
Reintervention within 12 months
Time Frame: 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
Secondary Outcomes
- Procedure time(12 hours)
- Mortality(One year)
- Hospital stay(One year)
- Health-related quality of life(Six months after surgery)
Investigators
Gabriel Sandblom
Associate Professor
Karolinska Institutet