Study Stopped
Lack of recruting patients to the study
Optimal Handling of Common Bile Duct Calculus, a Prospective Study
1 other identifier
interventional
35
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2011
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 27, 2011
CompletedFirst Submitted
Initial submission to the registry
October 9, 2012
CompletedFirst Posted
Study publicly available on registry
October 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedMarch 1, 2019
February 1, 2019
6 years
October 9, 2012
February 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
12 month post op
Secondary Outcomes (1)
Complications biliary calculus
12 month post op
Study Arms (2)
Biliary calculus remain
EXPERIMENTALbiliary calculus, less than or equal to 6 mm, remains
Biliary calculus removed
EXPERIMENTALbiliary calculus, less than or equal to 6 mm, removed
Interventions
Eligibility Criteria
You may qualify if:
- cholecystectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Karolinska University Hospitalcollaborator
- Danderyd Hospitalcollaborator
- Sodertalje Hospitalcollaborator
- Mora Hospitalcollaborator
- Regional Hopspital Ryhov, Jönköpingcollaborator
- University Hospital, Linkoepingcollaborator
- Vrinnevi Hospital, Norrköpingcollaborator
- Sundsvalls Hospitalcollaborator
Study Sites (9)
Regional Hospital Ryhov
Jönköping, SE-, Sweden
Linköping University Hospital
Linköping, SE-581 85, Sweden
Mora Hospital
Mora, SE-792 85, Sweden
Vrinnevi Hospital Norrköping
Norrköping, SE-, Sweden
Södertälje Hospital
Södertälje, SE-, Sweden
Ersta sjukhus
Stockholm, 116 91, Sweden
Karolinska University Hospital
Stockholm, SE-141 86, Sweden
Danderyds Hospital
Stockholm, SE-182 88, Sweden
Sundsvalls Hospital
Sundsvall, SE-, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anders Thorell, Assoc Prof
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ass. Prof.
Study Record Dates
First Submitted
October 9, 2012
First Posted
October 16, 2012
Study Start
November 27, 2011
Primary Completion
November 20, 2017
Study Completion
January 1, 2018
Last Updated
March 1, 2019
Record last verified: 2019-02