CholelithiasisNCT01708109
Optimal Handling of Common Bile Duct Calculus, a Prospective Study
A study testing no measures taken to clear bile ductus and clearance of bile ductus in people with Cholelithiasis, run by Karolinska Institutet at 9 sites in Sweden.
Trial summary
The purpose is to study natural process of gallstones in common bile duct, stones less than or equal to 6 mm. And if the gallstones give any complications under 1 year follow up. The second outcome is to study side-effects of gallstones removed with surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- no measures taken to clear bile ductus and clearance of bile ductus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 9 sitesSweden
- Study dates
- 27 Nov 2011to Jan 2018
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cholecystectomy
Who cannot join
- Ongoing icterus or pancreatitis
- History of anamneses pancreatitis/icterus
- Allergy against x-ray contrast
- Stones more than 6 mm in ductus
- No passage of contrast to duodenum
- malignant
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Sweden9 sites
Regional Hospital Ryhov
Jönköping, SE-
Linköping University Hospital
Linköping, SE-581 85
Mora Hospital
Mora, SE-792 85
Vrinnevi Hospital Norrköping
Norrköping, SE-
Södertälje Hospital
Södertälje, SE-
Ersta sjukhus
Stockholm, 116 91
Karolinska University Hospital
Stockholm, SE-141 86
Danderyds Hospital
Stockholm, SE-182 88
Sundsvalls Hospital
Sundsvall, SE-
About this study
Official title: Optimal Handling of Common Bile Duct Calculus, a Prospective Randomized Study
The purpose is to study natural process of gallstones in common bile duct, stones less than or equal to 6 mm. And if the gallstones give any complications under 1 year follow up. The second outcome is to study side-effects of gallstones removed with surgery.
- Conditions
- Cholelithiasis
- Being tested
- no measures taken to clear bile ductus, clearance of bile ductus
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no measures taken to clear bile ductusOther
biliary calculus remain
clearance of bile ductusProcedure or surgery
biliary calculus removed at surgery
| Study group | Role | What they receive |
|---|---|---|
| Biliary calculus remain | Experimental | biliary calculus, less than or equal to 6 mm, remains Receives: Other: no measures taken to clear bile ductus |
| Biliary calculus removed | Experimental | biliary calculus, less than or equal to 6 mm, removed Receives: Procedure: clearance of bile ductus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural process of biliary calculus left after cholecystectomy
Calculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed
Measured: 12 month post op
Secondary outcomes (1)
Complications biliary calculus
Calculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed
Measured: 12 month post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study start27 Nov 2011
- Primary completion20 Nov 2017
- Study completionJan 2018
Why it stopped: Lack of recruting patients to the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Danderyd Hospital, Sodertalje Hospital, Mora Hospital, Regional Hopspital Ryhov, Jönköping, University Hospital, Linkoeping, Vrinnevi Hospital, Sundsvalls Hospital
- Responsible party
- Principal investigator, Anders Thorell, Karolinska Institutet
- Investigators
- Anders Thorell, Assoc Prof, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708109
- Sponsor's protocol ID
- 2011/873-31/3
- Status last verified
- Feb 2019
- First submitted
- 9 Oct 2012
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Handling of Common Bile Duct Calculus, a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01708109
- Acronym / sponsor ID
- 2011/873-31/3
- Conditions
- Cholelithiasis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruting patients to the study
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Danderyd Hospital, Sodertalje Hospital, Mora Hospital, Regional Hopspital Ryhov, Jönköping, University Hospital, Linkoeping, Vrinnevi Hospital, Sundsvalls Hospital
- Study start
- 27 Nov 2011 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 16 Oct 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 purpose is to study natural process of gallstones in common bile duct, stones less than or equal to 6 mm. And if the gallstones give any complications under 1 year follow up. The second outcome is to study side-effects of gallstones removed with surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biliary calculus remain | Experimental | Other: no measures taken to clear bile ductusbiliary calculus, less than or equal to 6 mm, remains |
| Biliary calculus removed | Experimental | Procedure: clearance of bile ductusbiliary calculus, less than or equal to 6 mm, removed |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- cholecystectomy
Key exclusion criteria (6 listed)
- Ongoing icterus or pancreatitis
- History of anamneses pancreatitis/icterus
- Allergy against x-ray contrast
- Stones more than 6 mm in ductus
- No passage of contrast to duodenum
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 |
|---|---|---|
| no measures taken to clear bile ductusbiliary calculus remain | Other | Biliary calculus remain |
| clearance of bile ductusbiliary calculus removed at surgery | Procedure or surgery | Biliary calculus removed |
Primary outcome
Natural process of biliary calculus left after cholecystectomy
Time frame: 12 month post op
Calculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed
1 secondary outcome
Complications biliary calculus
Time frame: 12 month post op
Results and safety
The study was stopped early (reason given: Lack of recruting patients to the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
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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.
Anders Thorell, Assoc Prof principal investigator
Karolinska Institutet
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing no measures taken to clear bile ductus and clearance of bile ductus in people with Cholelithiasis, run by Karolinska Institutet at 9 sites 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 6 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: stopped early, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 was stopped early (reason given: Lack of recruting patients to the study). Results are not available in the source record.
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?
Natural process of biliary calculus left after cholecystectomy (time frame: 12 month post op). 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 1 Mar 2019.