Cholecystectomy With Intraoperative Management of Bile Duct Stones in Norway - the BILNOR Study (Bilnor)

March 4, 2026 updated by: Magnus Fasting, Oslo University Hospital
The BILNOR study is a prospective multicenter observational study evaluating how common bile duct stones are best managed in patients undergoing cholecystectomy. The study focuses particularly on transcystic laparoscopic common bile duct exploration (LCBDE) and assesses stone clearance, technical success, complications, and health-economic outcomes in routine clinical practice. A secondary aim is to compare LCBDE with intraoperative ERCP regarding efficacy, complication rates, and costs. Approximately 340 patients from several Norwegian centers are planned to be included starting in March 2026.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The BILNOR study (Cholecystectomy with intraoperative management of bile duct stones in Norway) is a prospective, multicenter observational study evaluating how common bile duct stones (CBDS) are best managed when patients also need a cholecystectomy. Although ERCP followed by later cholecystectomy is still the most frequently used strategy, it often requires two separate procedures, with additional discomfort, risk, admissions, and costs. Single-stage alternatives-either intraoperative ERCP (including rendezvous techniques) or laparoscopic common bile duct exploration (LCBDE)-may reduce resource use and improve the patient pathway, but are unevenly available across Norwegian hospitals and have differing complication profiles.

The primary focus of BILNOR is transcystic LCBDE, a technique implemented at Oslo University Hospital in 2019 using a structured "step-up" approach (e.g., saline flushing, pharmacologic relaxation, guidewire passage, papillary balloon dilatation up to 8 mm, and transcystic choledochoscopy with stone extraction; intraoperative ERCP if needed/available). The study will estimate real-world stone clearance (defined as no repeat biliary intervention within 90 days), technical success (intraoperative clearance on cholangiography), and 30-day complications including a study-specific definition of post-procedure pancreatitis, as well as bile leak and other Clavien-Dindo graded events. Health economic outcomes (length of stay and costs per patient) and which procedural steps are most often required to achieve clearance are also assessed.

A secondary aim is to compare LCBDE with intraoperative ERCP regarding efficacy, complication rates, and costs, including a non-inferiority assessment for stone clearance. The planned total sample size is approximately 340 patients (155 per group plus allowae for dropouts). Learning-curve effects will be addressed with center-level sensitivity analyses excluding early cases. Inclusion is planned to start March 1, 2026, with expansion to additional centers as the technique spreads in Norway.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
340

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Magnus H Fasting, MD, PhD, FEBS (UGI)
  • Phone Number: 0047 22800000
  • Email: magfas@ous-hf.no

Study Locations

  • Norway
      • Oslo, Norway
        • Recruiting
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Eligible patients will be identified during routine clinical evaluation by the treating surgical team. Either in the outpatient clinic or in the ward for emergency admitted patients.

Description

Inclusion criteria:

  • Age over 18 years

  • Preoperatively image proven choledocholithiasis or bile duct sludge (US / CT / MRI)

    • ≤ 8 mm size
    • ≤ 5 stones
    • Not proximal bile duct stones
  • Planned cholecystectomy with intraoperative bile duct clearance (LCBDE or intraoperative ERCP)

Exclusion criteria:

  • Previous cholecystectomy
  • Medically unfit for surgery (frailty, comorbidity)
  • Technically inoperable (hostile abdomen, inflammatory processes, bleeding conditions, cirrhosis)
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
LC+LCBDE
Laparoscopic cholecystectomy and inhtraoperative bile duct clearance.
LC+IOERCP
Laparoscopic cholecystectomy and ERCP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reintervention rate
Time Frame: 90 days
Bile duct reintervention rate
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2036

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 964437

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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