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Intraoperative ERCP Versus Therapeutic Splitting in Cholecysto-, Choledocholithiasis

Sponsor
Kepler University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06130163
Collaborator
(none)
200
Enrollment
1
Location
41.9
Actual Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

At our hospital (Kepler University Hospital Linz) we perform all variants of ERCP (preoperative, intraoperative, postoperative ERCP). In cases of simultaneous cholecysto- and choledocholithiasis. Hardly any other hospital in Austria prefers intraoperative ERCP or offers it at all. We have established a standardized procedure with implemented logistics. We want to compare intraoperative and postoperative ERCP.

Condition or Disease Intervention/Treatment Phase
  • Procedure: endoscopic retrograde cholangiopancreatography

Detailed Description

At our hospital (Kepler University Hospital Linz) we perform all variants of ERCP (preoperative, intraoperative, postoperative ERCP). In cases of simultaneous cholecysto- and choledocholithiasis, we prefer an intraoperative ERCP followed by a preoperative ERCP. We have 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. We have established a standardized procedure with implemented logistics.

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 our clinic.

Study Design

Study Type:
Observational
Actual Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Benefits and Advantages of Intraoperative ERCP Versus Therapeutic Splitting in Cholecysto-, Choledocholithiasis in a High Expertise Center
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Jun 30, 2023
Actual Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Post-ERCP Pancreatitis [48 hours after intervention]

      radiological/blood sample/pain

    Secondary Outcome Measures

    1. LOS [9 months after first admission]

      length of stay

    2. Surgical method [at surgery]

      LSK, robotic, open

    3. Re-choledocholithiasis [up to one year after first admission]

      choledocholithiasis after ERCP

    4. Re-Intervenition [30 days after surgery and/or ERCP]

      any endoscopic/surgical/radiological intervention after surgery or ERCP

    5. Successful ERCP [at ERCP]

      yes or no

    6. Costs [until 30 days after second surgery and/or ERCP]

      costs for one patient

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • simultaneous cholecysto-, choledocholithiasis

    • emergency or elective

    • confirmed choledocholithiasis

    • intraoperative ERCP

    • preoperative ERCP followed by cholecystectomy

    • postoperative ERCP

    Exclusion Criteria:
    • < 18 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kepler University Hosital Linz Linz Austria 4020

    Sponsors and Collaborators

    • Kepler University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Sandra Raab, Dr. med. univ., Kepler University Hospital
    ClinicalTrials.gov Identifier:
    NCT06130163
    Other Study ID Numbers:
    • ERCP
    First Posted:
    Nov 14, 2023
    Last Update Posted:
    Nov 14, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cholelithiasis
    Cholecystolithiasis
    Gallstones
    Choledocholithiasis

    Study Results

    No Results Posted as of Nov 14, 2023