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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
Sponsor:
Collaborators:
Karolinska University Hospital
Danderyd Hospital
Sodertalje Hospital
Mora Hospital
Regional Hopspital Ryhov, Jönköping
University Hospital, Linkoeping
Vrinnevi Hospital, Norrköping
Sundsvalls Hospital
Information provided by (Responsible Party):
Anders Thorell, Karolinska Institutet

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Cholelithiasis Other: no measures taken to clear bile ductus Procedure: clearance of bile ductus Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
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-
Sponsors and Collaborators
Karolinska Institutet
Karolinska University Hospital
Danderyd Hospital
Sodertalje Hospital
Mora Hospital
Regional Hopspital Ryhov, Jönköping
University Hospital, Linkoeping
Vrinnevi Hospital, Norrköping
Sundsvalls Hospital
Investigators
Principal Investigator: Anders Thorell, Assoc Prof Karolinska Institutet
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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