Optimal Handling of Common Bile Duct Calculus, a Prospective Study
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ClinicalTrials.gov Identifier: NCT01708109 |
Recruitment Status
:
Active, not recruiting
First Posted
: October 16, 2012
Last Update Posted
: March 20, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cholelithiasis | Other: no measures taken to clear bile ductus Procedure: clearance of bile ductus | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Optimal Handling of Common Bile Duct Calculus, a Prospective Randomized Study |
Study Start Date : | November 2011 |
Estimated Primary Completion Date : | December 2018 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Biliary calculus remain
biliary calculus, less than or equal to 6 mm, remains
|
Other: no measures taken to clear bile ductus
biliary calculus remain
|
Experimental: Biliary calculus removed
biliary calculus, less than or equal to 6 mm, removed
|
Procedure: clearance of bile ductus
biliary calculus removed at surgery
|
- 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
- Complications biliary calculus [ 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

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708109
Sweden | |
Regional Hospital Ryhov | |
Jönköping, Sweden, SE- | |
Linköping University Hospital | |
Linköping, Sweden, SE-581 85 | |
Mora Hospital | |
Mora, Sweden, SE-792 85 | |
Vrinnevi Hospital Norrköping | |
Norrköping, Sweden, SE- | |
Ersta sjukhus | |
Stockholm, Sweden, 116 91 | |
Karolinska University Hospital | |
Stockholm, Sweden, SE-141 86 | |
Danderyds Hospital | |
Stockholm, Sweden, SE-182 88 | |
Sundsvalls Hospital | |
Sundsvall, Sweden, SE- | |
Södertälje Hospital | |
Södertälje, Sweden, SE- |
Principal Investigator: | Anders Thorell, Assoc Prof | Karolinska Institutet |
Responsible Party: | Anders Thorell, Ass. Prof., Karolinska Institutet |
ClinicalTrials.gov Identifier: | NCT01708109 History of Changes |
Other Study ID Numbers: |
2011/873-31/3 |
First Posted: | October 16, 2012 Key Record Dates |
Last Update Posted: | March 20, 2018 |
Last Verified: | March 2018 |
Additional relevant MeSH terms:
Calculi Cholelithiasis Cholecystolithiasis Gallstones |
Pathological Conditions, Anatomical Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases |