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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

October 9, 2012
March 11, 2014
November 2011
December 2016   (final data collection date for primary outcome measure)
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
Natural process of bilary calculus left after cholesystecthomy [ 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 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 ] [ 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
Complications bilary 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 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 Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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
    Intervention: Other: no measures taken to clear bile ductus
  • Experimental: Biliary calculus removed
    biliary calculus, less than or equal to 6 mm
    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.
 
Recruiting
200
Not Provided
December 2016   (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
Both
18 Years to 80 Years
No
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
Sweden
 
NCT01708109
2011/873-31/3
Yes
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 2014

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