Laparoscopic Endobiliary Stent and Postoperative ERCP Compared to Intraoperative ERCP

NCT06817291 | Completed

• 1 other identifier: 2023-05310-01
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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

Conditions

Common Bile Duct Stones

Outcome Measures

Primary Outcomes (1)

• Complication after cholecystectomy and the following ERCP

  Number of participants with treatment-related adverse events such as pancreatitis, cholangitis, bleeding, infection, gall leakage

  30 days after each procedure

Study Arms (2)

Laparoscopic endobiliary stent and postponed ERCP

Intraoperatively found common bile duct stones treated with laparoscopic endobiliaty stent and postoperative ERCP

Procedure: Laparoscopic endobiliary stent

Intraoperativ ERCP

Intraoperatively found common bile duct stones treated with intraoperative ERCP

Interventions

Laparoscopic endobiliary stent PROCEDURE

During laparoscopic gallblader surgery, a quidewire is inserted in the cystic duct, via the common bile duct and advanced into the duodenum. The plastic stent is threaded over the wire and pushed in position, with a catheter. When the stent is crossing the papilla, the wire is first removed, and then the catheter. The procedure is done under x-ray guidance.

Laparoscopic endobiliary stent and postponed ERCP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be identified in the GallRiks registry with found of CBDS at intraoperative cholangiography, IOC, and thereafter treated with ERCP during 2010-01-01 to 2023-12-31.

You may qualify if:

• Laparoscopic choleystectomy with intraoperative found of common bile duct stones by intraoperative cholangiography.
• Common bile duct treated with laparoscopic endobiliary stent and postponed ERCP or intraoperative ERCP

You may not qualify if:

• Other types of treatment for common bile duct stones Conversion to or open cholecystectomy

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Department of Clinical Sciences, Danderyd Hospital

Stockholm, Sweden

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 10, 2025
• Study Start: March 20, 2024
• Primary Completion: November 11, 2024
• Study Completion: November 11, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)