Intraoperative ERCP Versus Therapeutic Splitting in Cholecysto-, Choledocholithiasis

Completed

• Conditions: Cholelithiasis, Common Bile Duct
• Interventions: Procedure: endoscopic retrograde cholangiopancreatography

• Registration Number: NCT06130163
• Lead Sponsor: Kepler University Hospital

Brief Summary

At the Kepler University Hospital Linz all variants of ERCP (preoperative, intraoperative, postoperative ERCP) are performed in cases of simultaneous cholecysto- and choledocholithiasis. Hardly any other hospital in Austria prefers intraoperative ERCP or offers it at all. A standardized procedure with implemented logistics has been established. This study compares intraoperative and postoperative ERCP.

Detailed Description

At the Kepler University Hospital Linz all variants of ERCP (preoperative, intraoperative, postoperative ERCP) in cases of simultaneous cholecysto- and choledocholithiasis are performed. Usually an intraoperative ERCP followed by a preoperative ERCP is preferred. At the Kepler University hospital a high level of expertise in endoscopy and an interdisciplinary endoscopy team (surgical and internal medicine department) makes this high level of effort possible. Hardly any other hospital in Austria prefers intraoperative ERCP or offers it at all. A standardized procedure with implemented logistics has been established.

The aim of this study is to demonstrate and compare the advantages of both procedures at KUK from 1.1.2020 to 30.6.2023 (intraoperative and postoperative ERCP) in terms of morbidity, endoscopic success and the better way for patients and surgeons in clinics.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-11
• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-14
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• simultaneous cholecysto-, choledocholithiasis
• emergency or elective
• confirmed choledocholithiasis
• intraoperative ERCP
• preoperative ERCP followed by cholecystectomy
• postoperative ERCP

Exclusion Criteria

• < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Splitting	endoscopic retrograde cholangiopancreatography	Patients with cholecystocholedocholithiasis getting therapeutic splitting
Intraoperative ERCP	endoscopic retrograde cholangiopancreatography	Patients with cholecystocholedocholithiasis getting intraoperative ERCP

Primary Outcome Measures

Name	Time	Method
Post-ERCP Pancreatitis	48 hours after intervention	radiological/blood sample/pain

Secondary Outcome Measures

Name	Time	Method
Re-choledocholithiasis	up to one year after first admission	choledocholithiasis after ERCP
Surgical method	at surgery	LSK, robotic, open
Successful ERCP	at ERCP	yes or no
Re-Intervenition	30 days after surgery and/or ERCP	any endoscopic/surgical/radiological intervention after surgery or ERCP
LOS	9 months after first admission	length of stay
Costs	until 30 days after second surgery and/or ERCP	costs for one patient

Trial Locations

Locations (1)

Kepler University Hosital Linz; 🇦🇹 Linz, Austria