Intraoperative ERCP Versus Therapeutic Splitting in Cholecysto-, Choledocholithiasis

March 3, 2025 updated by: Dr. Sandra Raab, Kepler University Hospital

Benefits and Advantages of Intraoperative ERCP Versus Therapeutic Splitting in Cholecysto-, Choledocholithiasis in a High Expertise Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4020
        • Kepler University Hosital Linz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing surgery and ERCP in context to cholecysto-, choledocholithiasis in out hospital

Description

Inclusion Criteria:

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

Exclusion Criteria:

- < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intraoperative ERCP
Patients with cholecystocholedocholithiasis getting intraoperative ERCP
Procedure: endoscopic retrograde cholangiopancreatography
endoscopical clearance of the common bile duct
Other Names:
  • ERCP
Splitting
Patients with cholecystocholedocholithiasis getting therapeutic splitting
Procedure: endoscopic retrograde cholangiopancreatography
endoscopical clearance of the common bile duct
Other Names:
  • ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-ERCP Pancreatitis
Time Frame: 48 hours after intervention
radiological/blood sample/pain
48 hours after intervention

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kepler University Hospital

Investigators

  • Study Chair: Andreas Shamiyeh, Dr., Kepler University Hospital Linz
  • Principal Investigator: Sandra Raab, Dr., Kepler University Hospital Linz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

November 8, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERCP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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