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CompletedNCT06130163Updated Mar 6, 2025

Intraoperative ERCP Versus Therapeutic Splitting in Cholecysto-, Choledocholithiasis

An observational study in Cholelithiasis, Common Bile Duct, sponsored by Kepler University Hospital. Completed at 1 site in Austria. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-06.

Sponsored by Kepler University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
200
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cholelithiasis, Common Bile Duct

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03

In context

Choledocholithiasis

109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.

This study's enrollment of 200 is close to the median of 200 across 31 observational studies indexed under Choledocholithiasis.

Browse Choledocholithiasis studies →

Lead sponsor

Kepler University Hospital is the lead sponsor of 32 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • \< 18 years
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • Intraoperative ERCP

    Patients with cholecystocholedocholithiasis getting intraoperative ERCP

    Procedure: endoscopic retrograde cholangiopancreatography

  • Splitting

    Patients with cholecystocholedocholithiasis getting therapeutic splitting

    Procedure: endoscopic retrograde cholangiopancreatography

Interventions

  • Procedureendoscopic retrograde cholangiopancreatography

    endoscopical clearance of the common bile duct

    Also known as: ERCP

06

What researchers measure

Primary outcomes

  1. Post-ERCP Pancreatitis

    radiological/blood sample/pain

    Time frame: 48 hours after intervention

Secondary outcomes

  1. LOS

    length of stay

    Time frame: 9 months after first admission

  2. Surgical method

    LSK, robotic, open

    Time frame: at surgery

  3. Re-choledocholithiasis

    choledocholithiasis after ERCP

    Time frame: up to one year after first admission

  4. Re-Intervenition

    any endoscopic/surgical/radiological intervention after surgery or ERCP

    Time frame: 30 days after surgery and/or ERCP

  5. Successful ERCP

    yes or no

    Time frame: at ERCP

  6. Costs

    costs for one patient

    Time frame: until 30 days after second surgery and/or ERCP

07

Study locations

1 site
  • Kepler University Hosital Linz
    Linz, 4020, Austria
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2020 to primary completion in Jun 2023, 41 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2023
First posted
Nov 14, 2023
StartActual
Jan 1, 2020
Primary completionActual
Jun 30, 2023
CompletionActual
Jun 30, 2023
Last update
Mar 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06130163
Lead sponsor
Kepler University Hospital
Responsible party
Dr. Sandra Raab (Dr. med. univ., Kepler University Hospital) — Principal investigator
First posted
Nov 14, 2023
Start date
Jan 1, 2020
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023
Last update
Mar 6, 2025

Study contacts

Andreas Shamiyeh, Dr.
study chair · Kepler University Hospital Linz
Sandra Raab, Dr.
principal investigator · Kepler University Hospital Linz

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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