Back to resultsOptimal Handling of Common Bile Duct Calculus, a Prospective Study
Primary Purpose
Cholelithiasis
Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
no measures taken to clear bile ductus
clearance of bile ductus
Sponsored by
About this trial
This is an interventional treatment trial for Cholelithiasis
Eligibility Criteria
Inclusion Criteria:
- cholecystectomy
Exclusion Criteria:
- 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
Sites / Locations
- Regional Hospital Ryhov
- Linköping University Hospital
- Mora Hospital
- Vrinnevi Hospital Norrköping
- Ersta sjukhus
- Karolinska University Hospital
- Danderyds Hospital
- Sundsvalls Hospital
- Södertälje Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Biliary calculus remain
Biliary calculus removed
Arm Description
biliary calculus, less than or equal to 6 mm, remains
biliary calculus, less than or equal to 6 mm, removed
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Complications biliary calculus
Calculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed
Full Information
NCT ID
NCT01708109
First Posted
October 9, 2012
Last Updated
February 27, 2019
Sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital, Danderyd Hospital, Sodertalje Hospital, Mora Hospital, Regional Hopspital Ryhov, Jönköping, University Hospital, Linkoeping, Vrinnevi Hospital, Norrköping, Sundsvalls Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01708109
Brief Title
Optimal Handling of Common Bile Duct Calculus, a Prospective Study
Official Title
Optimal Handling of Common Bile Duct Calculus, a Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruting patients to the study
Study Start Date
November 27, 2011 (Actual)
Primary Completion Date
November 20, 2017 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital, Danderyd Hospital, Sodertalje Hospital, Mora Hospital, Regional Hopspital Ryhov, Jönköping, University Hospital, Linkoeping, Vrinnevi Hospital, Norrköping, Sundsvalls Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biliary calculus remain
Arm Type
Experimental
Arm Description
biliary calculus, less than or equal to 6 mm, remains
Arm Title
Biliary calculus removed
Arm Type
Experimental
Arm Description
biliary calculus, less than or equal to 6 mm, removed
Intervention Type
Other
Intervention Name(s)
no measures taken to clear bile ductus
Intervention Description
biliary calculus remain
Intervention Type
Procedure
Intervention Name(s)
clearance of bile ductus
Intervention Description
biliary calculus removed at surgery
Primary Outcome Measure Information:
Title
Natural process of biliary calculus left after cholecystectomy
Description
Calculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed
Time Frame
12 month post op
Secondary Outcome Measure Information:
Title
Complications biliary calculus
Description
Calculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed
Time Frame
12 month post op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
cholecystectomy
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Thorell, Assoc Prof
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional Hospital Ryhov
City
Jönköping
ZIP/Postal Code
SE-
Country
Sweden
Facility Name
Linköping University Hospital
City
Linköping
ZIP/Postal Code
SE-581 85
Country
Sweden
Facility Name
Mora Hospital
City
Mora
ZIP/Postal Code
SE-792 85
Country
Sweden
Facility Name
Vrinnevi Hospital Norrköping
City
Norrköping
ZIP/Postal Code
SE-
Country
Sweden
Facility Name
Ersta sjukhus
City
Stockholm
ZIP/Postal Code
116 91
Country
Sweden
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
SE-141 86
Country
Sweden
Facility Name
Danderyds Hospital
City
Stockholm
ZIP/Postal Code
SE-182 88
Country
Sweden
Facility Name
Sundsvalls Hospital
City
Sundsvall
ZIP/Postal Code
SE-
Country
Sweden
Facility Name
Södertälje Hospital
City
Södertälje
ZIP/Postal Code
SE-
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Optimal Handling of Common Bile Duct Calculus, a Prospective Study
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