Clinical trial NCT06817291: Laparoscopic Endobiliary Stent and Postoperative ERCP Compared to Intraoperative ERCP
Official title: Laparoscopic Endobiliary Stent and Postopertive ERCP Compared to Intraoperative ERCP for the Treatment of Common Bile Duct Stones: A Swedish Registry Bases Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Common Bile Duct Stones
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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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Primary outcomes:
measure: Complication after cholecystectomy and the following ERCP
timeFrame: 30 days after each procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Clinical Sciences, Danderyd Hospital
Study officials:
References: