Optimal Handling of Common Bile Duct Calculus, a Prospective Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Karolinska Institutet
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
ClinicalTrials.gov Identifier:
NCT01708109
First received: October 9, 2012
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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 Intervention
Cholelithiasis
Other: no measures taken to clear bile ductus
Procedure: clearance of bile ductus

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Optimal Handling of Common Bile Duct Calculus, a Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Natural process of biliary calculus left after cholecystectomy [ Time Frame: 12 month post op ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 month post op ] [ Designated as safety issue: Yes ]
    Calculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed


Estimated Enrollment: 200
Study Start Date: November 2011
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biliary calculus remain
biliary calculus, less than or equal to 6 mm
Other: no measures taken to clear bile ductus
biliary calculus remain
Experimental: Biliary calculus removed
biliary calculus, less than or equal to 6 mm
Procedure: clearance of bile ductus
biliary calculus removed at surgery

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708109

Contacts
Contact: Mats Möller, MD +46 (0) 8 7146201 ext 6201 mats.moller@erstadiakoni.se
Contact: Anders Thorell, Ass. Prof. +46 (0) 8 71406541 ext 6541 anders.thorell@erstadiakoni.se

Locations
Sweden
Regional Hospital Ryhov Recruiting
Jönköping, Sweden, SE-
Contact: Erik Svartholm    +46 (0) 36-321919    erik.svartholm@lj.se   
Sub-Investigator: Erik Svartholm         
Linköping University Hospital Recruiting
Linköping, Sweden, SE-581 85
Contact: Per Sandström       per.sandstrom@lio.se   
Sub-Investigator: Per Sandstrom         
Mora Hospital Recruiting
Mora, Sweden, SE-792 85
Contact: Johanna Österberg    +46(0)250-493321    johanna.osterberg@ltdalarna.se   
Sub-Investigator: Johanna Österberg         
Vrinnevi Hospital Norrköping Recruiting
Norrköping, Sweden, SE-
Contact: Kalev Teder       kalev.teder@lio.se   
Sub-Investigator: Kalev Teder         
Ersta sjukhus Recruiting
Stockholm, Sweden, 116 91
Contact: Mats Möller, MD    +46 (0) 8 714 6201 ext 6201    mats.moller@erstadiakoni.se   
Contact: Anders Thorell, Ass. Prof.    +46 (0) 8 7146541 ext 6541    anders.thorell@erstadiakoni.se   
Principal Investigator: Mats Möller, MD         
Karolinska University Hospital Recruiting
Stockholm, Sweden, SE-141 86
Contact: Gabriel Sandblom       gabriel.sandblom@ki.se   
Sub-Investigator: Gabriel Sandblom         
Danderyds Hospital Recruiting
Stockholm, Sweden, SE-182 88
Contact: Richard Marsk    +46 (0) 70-7608310    richard.marsk@ds.se   
Sub-Investigator: Richard Marsk         
Sundsvalls Hospital Recruiting
Sundsvall, Sweden, SE-
Contact: Yucel Cengiz       yucel.cengiz@lvn.se   
Sub-Investigator: Yucel Cengiz         
Södertälje Hospital Recruiting
Södertälje, Sweden, SE-
Contact: Anders Thörne    +46(0)8 550 241 67    Anders.thorne@sodertaljesjukhus.se   
Sub-Investigator: Anders Thörne         
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

No publications provided

Responsible Party: Anders Thorell, Ass. Prof., Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01708109     History of Changes
Other Study ID Numbers: 2011/873-31/3
Study First Received: October 9, 2012
Last Updated: March 11, 2014
Health Authority: Sweden: The National Board of Health and Welfare

Additional relevant MeSH terms:
Calculi
Cholelithiasis
Cholecystolithiasis
Gallstones
Pathological Conditions, Anatomical
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases

ClinicalTrials.gov processed this record on August 01, 2014