Brief Title
Fluorescence Cholangiography During Cholecystectomy - a RCT
Official Title
Fluorescence Cholangiography Versus X-ray Cholangiography During Laparoscopic Cholecystectomy for Complicated Gallstone Disease
Brief Summary
The primary objective is to compare the success rates of intraoperative fluorescent cholangiography using indocyanine green versus conventional X-ray cholangiography for the identification of bile duct anatomy during laparoscopic cholecystectomy for complicated gallstone disease in a randomized design with 120 patients.
Study Type
Interventional
Primary Outcome
Visualization of the cystic duct - common hepatic duct - common bile duct junction
Secondary Outcome
Time spend for intraoperative fluorescent cholangiography/conventional X-ray cholangiography
Condition
Cholecystitis
Intervention
Indocyanine green
Study Arms / Comparison Groups
Fluorescence cholangiography
Description: After induction of anaesthesia 2.5-7.5 mg of indocyanine green (0.05 mg/kg) is injected intravenously. The operation field is routinely inspected in the fluorescence imaging mode before dissection of Calot´s triangle. During dissection, the fluorescence imaging mode is used when needed, before division of any tubular structure and after division of the cystic duct and artery.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
120
Start Date
May 1, 2015
Completion Date
August 27, 2018
Primary Completion Date
August 27, 2018
Eligibility Criteria
Inclusion Criteria: - Patient scheduled for planned laparoscopic cholecystectomy by one surgeon - Complicated gallstone disease Exclusion Criteria: - Open cholecystectomy - Allergy towards iodine, urografin or indocyanine green - Liver or renal insufficiency - Thyrotoxicosis - Pregnancy or lactation - Legally incompetent for any reason - Withdrawal of inclusion consent at any time
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Lars ML Lehrskov-Schmidt, MD, ,
Administrative Informations
NCT ID
NCT02344654
Organization ID
2015-HVH-LLS-01
Responsible Party
Principal Investigator
Study Sponsor
Hvidovre University Hospital
Study Sponsor
Lars ML Lehrskov-Schmidt, MD, Principal Investigator, Hvidovre University Hospital
Verification Date
October 2018