Common Bile Duct StoneNCT01734720
Common Bile Duct Stones - Natural History and Interventions
An observational study of Common Bile Duct Stone, run by Karolinska Institutet.
Trial summary
The aims of this study were to 1. investigate what measures were taken when common bile duct stones (CBDS) were found intraoperatively in Sweden during the period May 2005 to December 2009 by using data from this population-based nationwide registry, and 2. Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Common Bile Duct Stone
- How many people
- 3,828 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Dec 2009
- 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 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing cholecystectomy with common bile duct stones found in peroperative cholangiogram
Who may be able to join
- common bile duct stones
Who cannot join
- none
About this study
Official title: Common Bile Duct Stones - Natural History and Interventions : Data From the Swedish Registry for Gallstone Surgery and Endoscopic Retrograde Cholangio Pancreatography (ERCP) (GallRiks)
The aims of this study were to
- investigate what measures were taken when common bile duct stones (CBDS) were found intraoperatively in Sweden during the period May 2005 to December 2009 by using data from this population-based nationwide registry, and
- analyze the outcome in terms of complications and success rates of bile duct clearance in relation to various stone sizes and interventions used. In order to further characterize the natural course of CBDS of various sizes, particular interest was focused on patients with positive findings where no peroperative measures to clear the bile ducts were taken or planned postoperatively.
- Conditions
- Common Bile Duct Stone
- Medical subject headings
- Gallstones
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 |
|---|---|---|
| common bile duct stone | Patients undergoing cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications in relation to strategy for handling CBDS
Complications reported to the registry at 30 day follow up after surgery
Measured: 30 days post operative
Secondary outcomes (1)
complications in relation to stone size
Complications reported to the registry at 30 day follow up after surgery
Measured: 30 days post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startMay 2005
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Bile Duct StoneStudies 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
- 3,828 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Ersta Hospital, Sweden
- Responsible party
- Principal investigator, Mats Möller, Karolinska Institutet
- Investigators
- Mats Möller, MD, Principal investigator, Karolinsks Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734720
- Sponsor's protocol ID
- 2010/533-31/2
- Status last verified
- Aug 2013
- First submitted
- 16 Nov 2012
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Common Bile Duct Stones - Natural History and Interventions : Data From the Swedish Registry for Gallstone Surgery and Endoscopic Retrograde Cholangio Pancreatography (ERCP) (GallRiks)
- ClinicalTrials.gov ID
- NCT01734720
- Acronym / sponsor ID
- 2010/533-31/2
- Conditions
- Common Bile Duct Stone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,828 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Ersta Hospital, Sweden
- Study start
- May 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Nov 2012 (estimated)
- 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 aims of this study were to
- investigate what measures were taken when common bile duct stones (CBDS) were found intraoperatively in Sweden during the period May 2005 to December 2009 by using data from this population-based nationwide registry, and
- analyze the outcome in terms of complications and success rates of bile duct clearance in relation to various stone sizes and interventions used. In order to further characterize the natural course of CBDS of various sizes, particular interest was focused on patients with positive findings where no peroperative measures to clear the bile ducts were taken or planned postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| common bile duct stone | – | –Patients undergoing cholecystectomy |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing cholecystectomy with common bile duct stones found in peroperative cholangiogram
Key inclusion criteria (1 listed)
- common bile duct stones
Key exclusion criteria (1 listed)
- none
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
complications in relation to strategy for handling CBDS
Time frame: 30 days post operative
Complications reported to the registry at 30 day follow up after surgery
1 secondary outcome
complications in relation to stone size
Time frame: 30 days post operative
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 29 Aug 2013.
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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.
Mats Möller, MD principal investigator
Karolinsks Institutet
Questions about this trial
What is this clinical trial studying?
An observational study of Common Bile Duct Stone, run by Karolinska Institutet.
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 1 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 29 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
complications in relation to strategy for handling CBDS (time frame: 30 days post operative). 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 29 Aug 2013.