Fluorescence Cholangiography During Cholecystectomy – a RCT

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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