Common Bile Duct StonesNCT06817291
Laparoscopic Endobiliary Stent and Postoperative ERCP Compared to Intraoperative ERCP
An observational study of Common Bile Duct Stones, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Laparoscopic endobiliary stent and postponed endoscopic retrograde cholangiopancreatography, ERCP, compared to intraoperative ERCP for the treatment of common bile duct stones, CBDS, a retrospective registry based cohort study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Bile Duct Stones
- What is being tested?
- Laparoscopic endobiliary stent
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 1 siteSweden
- Study dates
- 20 Mar 2024to 11 Nov 2024
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population will be identified in the GallRiks registry with found of CBDS at intraoperative cholangiography, IOC, and thereafter treated with ERCP during 2010-01-01 to 2023-12-31.
Who may be able to join
- Patients undergoing laparoscopic cholecystectomy diagnosed with common bile duct stones during the procedure and treated with ERCP or transcystic stent.
Who cannot join
- Other types of treatment for common bile duct stones Conversion to or open cholecystectomy
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Endobiliary Stent and Postopertive ERCP Compared to Intraoperative ERCP for the Treatment of Common Bile Duct Stones: A Swedish Registry Bases Study
Laparoscopic endobiliary stent and postponed endoscopic retrograde cholangiopancreatography, ERCP, compared to intraoperative ERCP for the treatment of common bile duct stones, CBDS, a retrospective registry based cohort study.
Data will be collected from GallRiks, the Swedish national registry for cholecystectomies and ERCP. Patients in the registry identified with found of CBDS at intraoperative cholangiography, IOC, and there after treated with ERCP during 2010-01-01 to 2023-12-31 are the study population.
Read more
Research question: In patients with intraoperatively diagnosed CBDS - is there a difference in complications between laparoparoscopic endobiliary stent with postoperative ERCP, and intraoperative ERCP? Primary outcome: Complications within 30 days after cholecystectomy and the following ERCP.
Secondary outcomes: 30 day mortality, procedure time for cholecystectomy, procedure time for ERCP, difficult cannulation, stone clearance at ERCP, cumulative hospital stay, readmission within 30 days after cholecystectomy/ERCP
Read the detailed description
In Sweden, the common bile duct is routinely examined during cholecystectomy, by using radiography with a contrast agent, IOC. Arguments for IOC are to clarify the anatomy, to detect possible bile duct injury, and to reveal stones in the CBD. Today many cholecystectomies in Sweden are performed in units with no or limited access to ERCP. In these cases, intraoperative ERCP is not always a viable option. Placing an endobiliary stent is an alternative when CBD stones are found intraoperatively by cholangiography. A guidewire can be inserted via the cholangiography-catheter (already placed in the duodenum after IOC), to the CBD, and further on into the duodenum. A plastic stent is then inserted over the wire. The stent is positioned to extend from the CDB into the duodenum. The endobiliary stent prevents bile obstruction from stones in the CBD. Subsequent ERCP, to remove stent and stones, can be postponed to a couple of weeks after the cholecystectomy. Endobiliary stents have been used to a smaller extent in Sweden since the 90s. Observational studies have described facilitation of cannulation during postoperative ERCP if an endobiliary stent has been placed.
Earlier studies publiched includes less than a hundred patients.
By using Swedish national registry data from GallRiks it will be possible to inlcude more patients then previsus studies with endobiliary stent, and also have a comparison group.
The study will compare morbidity with the treatment strategy endobiliary stent and postoperative ERCP to intraoperative ERCP. Intraoperative ERCP is gold standard in Sweden for management of CBDS found intraoperatively. Morbidity includes complications within 30 days from cholecystectomy and 30 days from ERCP.
There is a need to manage CBD stones detected during IOC in a safe and effective manner, even when intraoperative ERCP cannot be performed. Endobiliary stent is used in clinical practice today, and could be used to a larger extent, and become a valuable contribution in CBDS treatment, if the method would gain stronger scientific support.
- Conditions
- Common Bile Duct Stones
- Being tested
- Laparoscopic endobiliary stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic endobiliary stentProcedure or surgery
During laparoscopic gallblader surgery, a quidewire is inserted in the cystic duct, via the common bile duct and advanced into the duodenum. The plastic stent is threaded over the wire and pushed in position, with a catheter. When the stent is crossing the papilla, the wire is first removed, and then the catheter. The procedure is done under x-ray guidance.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic endobiliary stent and postponed ERCP | Intraoperatively found common bile duct stones treated with laparoscopic endobiliaty stent and postoperative ERCP Receives: Procedure: Laparoscopic endobiliary stent | |
| Intraoperativ ERCP | Intraoperatively found common bile duct stones treated with intraoperative ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication after cholecystectomy and the following ERCP
Number of participants with treatment-related adverse events such as pancreatitis, cholangitis, bleeding, infection, gall leakage
Measured: 30 days after each procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start20 Mar 2024
- Primary completion11 Nov 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Bile Duct StonesStudies 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
- Retrospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilla Runfors, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817291
- Sponsor's protocol ID
- 2023-05310-01
- Other IDs
- 2023
- Status last verified
- Aug 2026
- First submitted
- 24 Jan 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Endobiliary Stent and Postopertive ERCP Compared to Intraoperative ERCP for the Treatment of Common Bile Duct Stones: A Swedish Registry Bases Study
- ClinicalTrials.gov ID
- NCT06817291
- Acronym / sponsor ID
- 2023-05310-01
- Conditions
- Common Bile Duct Stones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 10 Feb 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.
Laparoscopic endobiliary stent and postponed endoscopic retrograde cholangiopancreatography, ERCP, compared to intraoperative ERCP for the treatment of common bile duct stones, CBDS, a retrospective registry based cohort study.
Data will be collected from GallRiks, the Swedish national registry for cholecystectomies and ERCP. Patients in the registry identified with found of CBDS at intraoperative cholangiography, IOC, and there after treated with ERCP during 2010-01-01 to 2023-12-31 are the study population.
Research question: In patients with intraoperatively diagnosed CBDS - is there a difference in complications between laparoparoscopic endobiliary stent with postoperative ERCP, and intraoperative ERCP? Primary outcome: Complications within 30 days after cholecystectomy and the following ERCP.
Secondary outcomes: 30 day mortality, procedure time for cholecystectomy, procedure time for ERCP, difficult cannulation, stone clearance at ERCP, cumulative hospital stay, readmission within 30 days after cholecystectomy/ERCP
Detailed description
In Sweden, the common bile duct is routinely examined during cholecystectomy, by using radiography with a contrast agent, IOC. Arguments for IOC are to clarify the anatomy, to detect possible bile duct injury, and to reveal stones in the CBD. Today many cholecystectomies in Sweden are performed in units with no or limited access to ERCP. In these cases, intraoperative ERCP is not always a viable option. Placing an endobiliary stent is an alternative when CBD stones are found intraoperatively by cholangiography. A guidewire can be inserted via the cholangiography-catheter (already placed in the duodenum after IOC), to the CBD, and further on into the duodenum. A plastic stent is then inserted over the wire. The stent is positioned to extend from the CDB into the duodenum. The endobiliary stent prevents bile obstruction from stones in the CBD. Subsequent ERCP, to remove stent and stones, can be postponed to a couple of weeks after the cholecystectomy. Endobiliary stents have been used to a smaller extent in Sweden since the 90s. Observational studies have described facilitation of cannulation during postoperative ERCP if an endobiliary stent has been placed.
Earlier studies publiched includes less than a hundred patients.
By using Swedish national registry data from GallRiks it will be possible to inlcude more patients then previsus studies with endobiliary stent, and also have a comparison group.
The study will compare morbidity with the treatment strategy endobiliary stent and postoperative ERCP to intraoperative ERCP. Intraoperative ERCP is gold standard in Sweden for management of CBDS found intraoperatively. Morbidity includes complications within 30 days from cholecystectomy and 30 days from ERCP.
There is a need to manage CBD stones detected during IOC in a safe and effective manner, even when intraoperative ERCP cannot be performed. Endobiliary stent is used in clinical practice today, and could be used to a larger extent, and become a valuable contribution in CBDS treatment, if the method would gain stronger scientific support.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic endobiliary stent and postponed ERCP | – | Procedure: Laparoscopic endobiliary stentIntraoperatively found common bile duct stones treated with laparoscopic endobiliaty stent and postoperative ERCP |
| Intraoperativ ERCP | – | –Intraoperatively found common bile duct stones treated with intraoperative ERCP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will be identified in the GallRiks registry with found of CBDS at intraoperative cholangiography, IOC, and thereafter treated with ERCP during 2010-01-01 to 2023-12-31.
Key inclusion criteria (1 listed)
- Patients undergoing laparoscopic cholecystectomy diagnosed with common bile duct stones during the procedure and treated with ERCP or transcystic stent.
Key exclusion criteria (2 listed)
- Other types of treatment for common bile duct stones Conversion to or open cholecystectomy
- -
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 |
|---|---|---|
| Laparoscopic endobiliary stentDuring laparoscopic gallblader surgery, a quidewire is inserted in the cystic duct, via the common bile duct and advanced into the duodenum. The plastic stent is threaded over the wire and pushed in position, with a catheter. When the stent is crossing the papilla, the wire is first removed, and then the catheter. The procedure is done under x-ray guidance. | Procedure or surgery | Laparoscopic endobiliary stent and postponed ERCP |
Primary outcome
Complication after cholecystectomy and the following ERCP
Time frame: 30 days after each procedure
Number of participants with treatment-related adverse events such as pancreatitis, cholangitis, bleeding, infection, gall leakage
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 13 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Common 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
ChOlanGiography Performed Routinely Versus Selectively During Cholecystectomy: A NAtional Registry-based Randomized Controlled Trial
Cholecystolithiasis, Common Bile Duct Gall Stones
Not yet recruiting
EUS-Guided Gallbladder Drainage Versus Conservative Management in Patients Unfit for Surgery After a Biliary Event Without Cholecystitis. DRECON Study
Cholecystectomy, Gallbladder
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.
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 Common Bile Duct Stones, run by Karolinska Institutet at 1 site in Sweden.
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 2 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 13 Aug 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 Sweden. 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?
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?
Complication after cholecystectomy and the following ERCP (time frame: 30 days after each procedure). 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 13 Aug 2026.