Gallstone DiseaseNCT07205380
GallRiks ERC Anesthesia Study
An observational study of Gallstone Disease, run by Karolinska Institutet.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) for common bile duct stones (CBDS) removal can be performed under varying levels of sedation. Deeper sedation has been associated with more successful cannulation, but little is known about the efficacy of ERCP measured as rate of retained CBDS depending on the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gallstone Disease
- What is being tested?
- Endoscopic Retrograde Cholangiopancreaticography
- Type of treatment
- Surgery or procedure
- How many people
- 121,252 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2007to 31 Dec 2022
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing ERCP for common bile duct stones
Who may be able to join
- ERCP performed for common bile duct stones
Who cannot join
- Suspicion of bile duct tumour
- ERCP performed during the seanse as a cholecystectomy
- Patients having undergone ERCP previously
About this study
Endoscopic retrograde cholangiopancreatography (ERCP) for common bile duct stones (CBDS) removal can be performed under varying levels of sedation. Deeper sedation has been associated with more successful cannulation, but little is known about the efficacy of ERCP measured as rate of retained CBDS depending on the level of sedation.
In this population-based, cohort study, using prospectively assembled register data from 121 252 ERCP procedures, adjusted odds ratio (OR) of retained CBDS 12 months after CBDS removal are analysed. Retained CBDS are defined as a repeated ERCP where CBDS are found.
- Conditions
- Gallstone Disease
- Being tested
- Endoscopic Retrograde Cholangiopancreaticography
- Keywords
- gallstone, ERCP, Anesthesia
- Medical subject headings
- Cholelithiasis, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Retrograde CholangiopancreaticographyProcedure or surgery
Anaesthesia or sedation during ERCP for common bile duct stones
| Study group | Role | What they receive |
|---|---|---|
| Swedish National Register for Gallstone Surgery and ERCP | Interventions for gallstones registered in Sweden Receives: Procedure: Endoscopic Retrograde Cholangiopancreaticography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ERCP for retained stones performed after the primary ERCP.
Retained common bile duct stones necessitating repeated ERCP within 12 months after the first ERCP
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Jan 2007
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallstone DiseaseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121,252 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Sandblom, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205380
- Sponsor's protocol ID
- GallRiks ERC anesthesia study
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymized data from the study are available on request from Gabriel Sandblom
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GallRiks ERC Anesthesia Study
- ClinicalTrials.gov ID
- NCT07205380
- Acronym / sponsor ID
- GallRiks ERC anesthesia study
- Conditions
- Gallstone Disease
- Keywords
- gallstone, ERCP, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121,252 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 Oct 2025 (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.
Endoscopic retrograde cholangiopancreatography (ERCP) for common bile duct stones (CBDS) removal can be performed under varying levels of sedation. Deeper sedation has been associated with more successful cannulation, but little is known about the efficacy of ERCP measured as rate of retained CBDS depending on the level of sedation.
In this population-based, cohort study, using prospectively assembled register data from 121 252 ERCP procedures, adjusted odds ratio (OR) of retained CBDS 12 months after CBDS removal are analysed. Retained CBDS are defined as a repeated ERCP where CBDS are found.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Swedish National Register for Gallstone Surgery and ERCP | – | Procedure: Endoscopic Retrograde CholangiopancreaticographyInterventions for gallstones registered in Sweden |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing ERCP for common bile duct stones
Key inclusion criteria (1 listed)
- ERCP performed for common bile duct stones
Key exclusion criteria (3 listed)
- Suspicion of bile duct tumour
- ERCP performed during the seanse as a cholecystectomy
- Patients having undergone ERCP previously
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 CholangiopancreaticographyAnaesthesia or sedation during ERCP for common bile duct stones | Procedure or surgery | Swedish National Register for Gallstone Surgery and ERCP |
Primary outcome
Incidence of ERCP for retained stones performed after the primary ERCP.
Time frame: 12 months
Retained common bile duct stones necessitating repeated ERCP within 12 months after the first 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 3 Oct 2025.
- Individual participant dataSharing planned: Yes. Pseudonymized data from the study are available on request from Gabriel Sandblom
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallstone Disease, run by Karolinska Institutet.
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 1 inclusion and 3 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 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of ERCP for retained stones performed after the primary ERCP. (time frame: 12 months). 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 3 Oct 2025.