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CompletedNCT07205380Updated Oct 3, 2025

GallRiks ERC Anesthesia Study

An observational study in Gallstone Disease, sponsored by Karolinska Institutet. Completed. Per ClinicalTrials.gov, last updated 2025-10-03.

Sponsored by Karolinska Institutet · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
121,252
Sex
All
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Study 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 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.

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Conditions studied

  • Gallstone Disease

Keywords

  • gallstone
  • ERCP
  • Anesthesia
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In context

Cholelithiasis

286 studies on the registry are indexed under Cholelithiasis; 48 are open to participants now.

This study's enrollment of 121,252 is above the median of 200 across 83 observational studies indexed under Cholelithiasis.

Browse Cholelithiasis studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

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

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing ERCP for common bile duct stones

Inclusion criteria

  • ERCP performed for common bile duct stones

Exclusion criteria

Exclusion Criteria:

  • Suspicion of bile duct tumour
  • ERCP performed during the seanse as a cholecystectomy
  • Patients having undergone ERCP previously
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
121,252 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Swedish National Register for Gallstone Surgery and ERCP

    Interventions for gallstones registered in Sweden

    Procedure: Endoscopic Retrograde Cholangiopancreaticography

Interventions

  • ProcedureEndoscopic Retrograde Cholangiopancreaticography

    Anaesthesia or sedation during ERCP for common bile duct stones

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes — Pseudonymized data from the study are available on request from Gabriel Sandblom

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07205380
Lead sponsor
Karolinska Institutet
Responsible party
Gabriel Sandblom (Associate Professor, Karolinska Institutet) — Principal investigator
First posted
Oct 3, 2025
Start date
Jan 1, 2007
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Oct 3, 2025

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 Sep 2025. You cannot join it, but the record below documents what was studied.

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