Laparoscopic Endobiliary Stent and Postopertive ERCP Compared to Intraoperative ERCP for the Treatment of Common Bile Duct Stones: A Swedish Registry Bases Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 1,200
- Locations
- 1
- Primary Endpoint
- Complication after cholecystectomy and the following ERCP
Study Overview
Brief Summary
Laparoscopic endobiliary stent and postponed endoscopic retrograde cholangiopancreatography, ERCP, compared to intraoperative ERCP for the treatment of common bile duct stones, CBDS, a retrospective registry based cohort study.
Data will be collected from GallRiks, the Swedish national registry for cholecystectomies and ERCP. Patients in the registry identified with found of CBDS at intraoperative cholangiography, IOC, and there after treated with ERCP during 2010-01-01 to 2023-12-31 are the study population.
Research question: In patients with intraoperatively diagnosed CBDS - is there a difference in complications between laparoparoscopic endobiliary stent with postoperative ERCP, and intraoperative ERCP? Primary outcome: Complications within 30 days after cholecystectomy and the following ERCP.
Secondary outcomes: 30 day mortality, procedure time for cholecystectomy, procedure time for ERCP, difficult cannulation, stone clearance at ERCP, cumulative hospital stay, readmission within 30 days after cholecystectomy/ERCP
Detailed Description
In Sweden, the common bile duct is routinely examined during cholecystectomy, by using radiography with a contrast agent, IOC. Arguments for IOC are to clarify the anatomy, to detect possible bile duct injury, and to reveal stones in the CBD. Today many cholecystectomies in Sweden are performed in units with no or limited access to ERCP. In these cases, intraoperative ERCP is not always a viable option. Placing an endobiliary stent is an alternative when CBD stones are found intraoperatively by cholangiography. A guidewire can be inserted via the cholangiography-catheter (already placed in the duodenum after IOC), to the CBD, and further on into the duodenum. A plastic stent is then inserted over the wire. The stent is positioned to extend from the CDB into the duodenum. The endobiliary stent prevents bile obstruction from stones in the CBD. Subsequent ERCP, to remove stent and stones, can be postponed to a couple of weeks after the cholecystectomy. Endobiliary stents have been used to a smaller extent in Sweden since the 90s. Observational studies have described facilitation of cannulation during postoperative ERCP if an endobiliary stent has been placed.
Earlier studies publiched includes less than a hundred patients.
By using Swedish national registry data from GallRiks it will be possible to inlcude more patients then previsus studies with endobiliary stent, and also have a comparison group.
The study will compare morbidity with the treatment strategy endobiliary stent and postoperative ERCP to intraoperative ERCP. Intraoperative ERCP is gold standard in Sweden for management of CBDS found intraoperatively. Morbidity includes complications within 30 days from cholecystectomy and 30 days from ERCP.
There is a need to manage CBD stones detected during IOC in a safe and effective manner, even when intraoperative ERCP cannot be performed. Endobiliary stent is used in clinical practice today, and could be used to a larger extent, and become a valuable contribution in CBDS treatment, if the method would gain stronger scientific support.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patients undergoing laparoscopic cholecystectomy diagnosed with common bile duct stones during the procedure and treated with ERCP or transcystic stent.
Exclusion Criteria
- Other types of treatment for common bile duct stones Conversion to or open cholecystectomy
Arms & Interventions
Laparoscopic endobiliary stent and postponed ERCP
Intraoperatively found common bile duct stones treated with laparoscopic endobiliaty stent and postoperative ERCP
Intervention: Laparoscopic endobiliary stent (Procedure)
Intraoperativ ERCP
Intraoperatively found common bile duct stones treated with intraoperative ERCP
Outcomes
Primary Outcomes
Complication after cholecystectomy and the following ERCP
Time Frame: 30 days after each procedure
Number of participants with treatment-related adverse events such as pancreatitis, cholangitis, bleeding, infection, gall leakage
Secondary Outcomes
No secondary outcomes reported
Investigators
Camilla Runfors
Principal investigator, Consultant Surgeon, PhD
Karolinska Institutet
Study Sites (1)
Identifiers
- NCT ID
- NCT06817291
- Other Study IDs
- 2023-05310-01
Dates
- First Submitted
- (last year)
- First Posted
- (last year)
- Primary Completion
- (last year)
- Study Completion
- (last year)
- Last Verified
- (2 months ago)
- Last updated
- (last month)
Regulatory & Sharing
- IPD Sharing Plan
- No
- Has Results
- No