Cholelithiasis, Common Bile DuctNCT06130163
Intraoperative ERCP Versus Therapeutic Splitting in Cholecysto-, Choledocholithiasis
An observational study of Cholelithiasis, Common Bile Duct, run by Kepler University Hospital at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholelithiasis, Common Bile Duct
- What is being tested?
- endoscopic retrograde cholangiopancreatography
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients undergoing surgery and ERCP in context to cholecysto-, choledocholithiasis in out hospital
Who may be able to join
- simultaneous cholecysto-, choledocholithiasis
- emergency or elective
- confirmed choledocholithiasis
- intraoperative ERCP
- preoperative ERCP followed by cholecystectomy
- postoperative ERCP
Who cannot join
- < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Cholelithiasis, Common Bile Duct
- Being tested
- endoscopic retrograde cholangiopancreatography
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic retrograde cholangiopancreatographyProcedure or surgery
Also called ERCP
endoscopical clearance of the common bile duct
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative ERCP | Patients with cholecystocholedocholithiasis getting intraoperative ERCP Receives: Procedure: endoscopic retrograde cholangiopancreatography | |
| Splitting | Patients with cholecystocholedocholithiasis getting therapeutic splitting Receives: Procedure: endoscopic retrograde cholangiopancreatography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-ERCP Pancreatitis
radiological/blood sample/pain
Measured: 48 hours after intervention
Secondary outcomes (6)
LOS
length of stay
Measured: 9 months after first admission
Surgical method
LSK, robotic, open
Measured: at surgery
Re-choledocholithiasis
choledocholithiasis after ERCP
Measured: up to one year after first admission
Re-Intervenition
any endoscopic/surgical/radiological intervention after surgery or ERCP
Measured: 30 days after surgery and/or ERCP
Successful ERCP
yes or no
Measured: at ERCP
Costs
costs for one patient
Measured: until 30 days after second surgery and/or ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start1 Jan 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholelithiasis, Common Bile DuctStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kepler University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sandra Raab, Kepler University Hospital
- Investigators
- Andreas Shamiyeh, Dr., Study chair, Kepler University Hospital LinzSandra Raab, Dr., Principal investigator, Kepler University Hospital Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130163
- Sponsor's protocol ID
- ERCP
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits and Advantages of Intraoperative ERCP Versus Therapeutic Splitting in Cholecysto-, Choledocholithiasis in a High Expertise Center
- ClinicalTrials.gov ID
- NCT06130163
- Acronym / sponsor ID
- ERCP
- Conditions
- Cholelithiasis, Common Bile Duct
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kepler University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoperative ERCP | – | Procedure: endoscopic retrograde cholangiopancreatographyPatients with cholecystocholedocholithiasis getting intraoperative ERCP |
| Splitting | – | Procedure: endoscopic retrograde cholangiopancreatographyPatients with cholecystocholedocholithiasis getting therapeutic splitting |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing surgery and ERCP in context to cholecysto-, choledocholithiasis in out hospital
Key inclusion criteria (6 listed)
- simultaneous cholecysto-, choledocholithiasis
- emergency or elective
- confirmed choledocholithiasis
- intraoperative ERCP
- preoperative ERCP followed by cholecystectomy
Key exclusion criteria (1 listed)
- < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic retrograde cholangiopancreatographyAlso: ERCPendoscopical clearance of the common bile duct | Procedure or surgery | Intraoperative ERCP, Splitting |
Primary outcome
Post-ERCP Pancreatitis
Time frame: 48 hours after intervention
radiological/blood sample/pain
6 secondary outcomes
LOS
Time frame: 9 months after first admission
Surgical method
Time frame: at surgery
Re-choledocholithiasis
Time frame: up to one year after first admission
Re-Intervenition
Time frame: 30 days after surgery and/or ERCP
Successful ERCP
Time frame: at ERCP
Costs
Time frame: until 30 days after second surgery and/or ERCP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Shamiyeh, Dr. study chair
Kepler University Hospital Linz
Sandra Raab, Dr. principal investigator
Kepler University Hospital Linz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholelithiasis, Common Bile Duct, run by Kepler University Hospital at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-ERCP Pancreatitis (time frame: 48 hours after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.