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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

October 9, 2012
October 16, 2012
March 20, 2018
November 2011
December 2018   (Final data collection date for primary outcome measure)
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
Natural process of bilary calculus left after cholesystecthomy [ Time Frame: 12 month post op ]
Calculus in common bile duct less than or equal to 6 mm found during cholecystecthomy, randomized to either remain or removed
Complete list of historical versions of study NCT01708109 on ClinicalTrials.gov Archive Site
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
Complications bilary calculus [ Time Frame: 12 month post op ]
Calculus in common bile duct less than or equal to 6 mm found during cholecystecthomy, randomized to either remain or removed
Not Provided
Not Provided
 
Optimal Handling of Common Bile Duct Calculus, a Prospective Study
Optimal Handling of Common Bile Duct Calculus, a Prospective Randomized Study
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Cholelithiasis
  • Other: no measures taken to clear bile ductus
    biliary calculus remain
  • Procedure: clearance of bile ductus
    biliary calculus removed at surgery
  • Experimental: Biliary calculus remain
    biliary calculus, less than or equal to 6 mm, remains
    Intervention: Other: no measures taken to clear bile ductus
  • Experimental: Biliary calculus removed
    biliary calculus, less than or equal to 6 mm, removed
    Intervention: Procedure: clearance of bile ductus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
Same as current
December 2018
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01708109
2011/873-31/3
Yes
Not Provided
Not Provided
Anders Thorell, Karolinska Institutet
Karolinska Institutet
  • Karolinska University Hospital
  • Danderyd Hospital
  • Sodertalje Hospital
  • Mora Hospital
  • Regional Hopspital Ryhov, Jönköping
  • University Hospital, Linkoeping
  • Vrinnevi Hospital, Norrköping
  • Sundsvalls Hospital
Principal Investigator: Anders Thorell, Assoc Prof Karolinska Institutet
Karolinska Institutet
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP