Laparoscopic Endobiliary Stent and Postoperative ERCP Compared to Intraoperative ERCP

NCT ID: NCT06817291

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-20
• Study Completion Date: 2024-11-11

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.

Conditions

Common Bile Duct Stones

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Laparoscopic endobiliary stent and postponed ERCP

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

Laparoscopic endobiliary stent

Intervention Type: 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.

Intraoperativ ERCP

Intraoperatively found common bile duct stones treated with intraoperative ERCP

No interventions assigned to this group

Interventions

Laparoscopic endobiliary stent

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Camilla Runfors

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Clinical Sciences, Danderyd Hospital

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

2023-05310-01

Identifier Type: -

Identifier Source: org_study_id