Intraoperative ERCP Versus Therapeutic Splitting in Cholecysto-, Choledocholithiasis

NCT ID: NCT06130163

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Cholelithiasis, Common Bile Duct

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Intraoperative ERCP

Patients with cholecystocholedocholithiasis getting intraoperative ERCP

endoscopic retrograde cholangiopancreatography

Intervention Type PROCEDURE

endoscopical clearance of the common bile duct

Splitting

Patients with cholecystocholedocholithiasis getting therapeutic splitting

endoscopic retrograde cholangiopancreatography

Intervention Type PROCEDURE

endoscopical clearance of the common bile duct

Interventions

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endoscopic retrograde cholangiopancreatography

endoscopical clearance of the common bile duct

Intervention Type PROCEDURE

Other Intervention Names

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ERCP

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- \< 18 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kepler University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Sandra Raab

Dr. med. univ.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Shamiyeh, Dr.

Role: STUDY_CHAIR

Kepler University Hospital Linz

Sandra Raab, Dr.

Role: PRINCIPAL_INVESTIGATOR

Kepler University Hospital Linz

Locations

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Kepler University Hosital Linz

Linz, Austria, Austria

Site Status

Countries

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Austria

Other Identifiers

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ERCP

Identifier Type: -

Identifier Source: org_study_id

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