NCT06130163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
Last Updated

March 6, 2025

Status Verified

November 1, 2023

Enrollment Period

3.5 years

First QC Date

November 8, 2023

Last Update Submit

March 3, 2025

Conditions

Cholelithiasis, Common Bile Duct

Outcome Measures

Primary Outcomes (1)

  • Post-ERCP Pancreatitis

    radiological/blood sample/pain

    48 hours after intervention

Secondary Outcomes (6)

  • LOS

    9 months after first admission

  • Surgical method

    at surgery

  • Re-choledocholithiasis

    up to one year after first admission

  • Re-Intervenition

    30 days after surgery and/or ERCP

  • Successful ERCP

    at ERCP

  • +1 more secondary outcomes

Study Arms (2)

Intraoperative ERCP

Patients with cholecystocholedocholithiasis getting intraoperative ERCP

Procedure: endoscopic retrograde cholangiopancreatography

Splitting

Patients with cholecystocholedocholithiasis getting therapeutic splitting

Procedure: endoscopic retrograde cholangiopancreatography

Interventions

endoscopic retrograde cholangiopancreatographyPROCEDURE

endoscopical clearance of the common bile duct

Also known as: ERCP
Intraoperative ERCPSplitting

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \- \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kepler University Hosital Linz

Linz, Austria, 4020, Austria

Location

MeSH Terms

Conditions

Choledocholithiasis

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Common Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasis

Intervention Hierarchy (Ancestors)

CholangiographyRadiography, AbdominalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Digestive SystemEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Andreas Shamiyeh, Dr.

    Kepler University Hospital Linz

    STUDY CHAIR

  • Sandra Raab, Dr.

    Kepler University Hospital Linz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. univ.

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 14, 2023

Study Start

January 1, 2020

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

March 6, 2025

Record last verified: 2023-11

Locations

AU(1)