NCT07449897

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
126mo left

Started Feb 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Feb 2026Dec 2036

Study Start

First participant enrolled

February 1, 2026

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2031

Expected
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2036

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

February 27, 2026

Last Update Submit

March 4, 2026

Conditions

Bile Duct Stones

Outcome Measures

Primary Outcomes (1)

  • Reintervention rate

    Bile duct reintervention rate

    90 days

Study Arms (2)

LC+LCBDE

Laparoscopic cholecystectomy and inhtraoperative bile duct clearance.

LC+IOERCP

Laparoscopic cholecystectomy and ERCP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Cholecystolithiasis

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Central Study Contacts

Magnus H Fasting, MD, PhD, FEBS (UGI)

CONTACT

0047 22800000magfas@ous-hf.no

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Surgeon, MD, PhD

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 4, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2031

Study Completion (Estimated)

December 1, 2036

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)