Bile Duct StonesBilnorNCT07449897
Cholecystectomy With Intraoperative Management of Bile Duct Stones in Norway - the BILNOR Study
An observational study of Bile Duct Stones, run by Oslo University Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Stones
- How many people
- 340 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2026to 1 Dec 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Previous cholecystectomy
- Medically unfit for surgery (frailty, comorbidity)
- Technically inoperable (hostile abdomen, inflammatory processes, bleeding conditions, cirrhosis)
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Bile Duct Stones
- Medical subject headings
- Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LC+LCBDE | Laparoscopic cholecystectomy and inhtraoperative bile duct clearance. | |
| LC+IOERCP | Laparoscopic cholecystectomy and ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reintervention rate
Bile duct reintervention rate
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Feb 2026
- Primary completion1 Feb 2031 (estimated)
- Study completion1 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct StonesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnus Fasting, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449897
- Sponsor's protocol ID
- 964437
- Acronym
- Bilnor
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholecystectomy With Intraoperative Management of Bile Duct Stones in Norway - the BILNOR Study
- ClinicalTrials.gov ID
- NCT07449897
- Acronym / sponsor ID
- Bilnor / 964437
- Conditions
- Bile Duct Stones
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Feb 2031 (estimated)
- Study completion
- 1 Dec 2036 (estimated)
- First posted
- 4 Mar 2026 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LC+LCBDE | – | –Laparoscopic cholecystectomy and inhtraoperative bile duct clearance. |
| LC+IOERCP | – | –Laparoscopic cholecystectomy and ERCP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Age over 18 years
- Preoperatively image proven choledocholithiasis or bile duct sludge (US / CT / MRI)
- Planned cholecystectomy with intraoperative bile duct clearance (LCBDE or intraoperative ERCP)
Key exclusion criteria (4 listed)
- Previous cholecystectomy
- Medically unfit for surgery (frailty, comorbidity)
- Technically inoperable (hostile abdomen, inflammatory processes, bleeding conditions, cirrhosis)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reintervention rate
Time frame: 90 days
Bile duct reintervention rate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Bile Duct Stones
Recruiting
ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
Cholecystectomy, Laparoscopic, Choledocholithiasis
Recruiting
Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis
Choledocholithiasis, Common Bile Duct Stones
RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Recruiting
Comparison of Vortic Catch V Basket Catheter and Ordinary Basket Catheter for the Removal of Bile Duct Stones
Randomized Study
Recruiting
ChOlanGiography Performed Routinely Versus Selectively During Cholecystectomy: A NAtional Registry-based Randomized Controlled Trial
Cholecystolithiasis, Common Bile Duct Gall Stones
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.
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 Bile Duct Stones, run by Oslo University Hospital at 1 site in Norway.
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 4 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: looking for participants now, as of the sponsor's last update on 6 Mar 2026. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magnus H Fasting, MD, PhD, FEBS (UGI) (0047 22800000, magfas@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reintervention rate (time frame: 90 days). 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 2026.