The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy
The purpose of this study is to evaluate whether a fluorescent die and a special infrared camera can assist with the identification of the important structures during laparoscopic cholecystectomy. This finding may assist surgeons to perform laparoscopic cholecystectomy in less time and in a safer fashion than standard laparoscopic cholecystectomy.
Colic of Gallbladder Without Mention of Cholecystitis
Drug: Indocyanine Green (ICG)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- operative time [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 48hours ] [ Designated as safety issue: No ]The primary endpoint will be operative time measured as the time from the beginning of the dissection until the gallbladder is separated entirely from the gall bladder fossa. Time from start of procedure until recognition of structures.
- Safety of operative technique [ Time Frame: 0- 14 days Postoeprative ] [ Designated as safety issue: Yes ]Patients will be followed for 14 days postop for signs of bile duct injury including bile duct leak and bile duct occlusion. This will be assessed by in person followup and/or telephone interview. Symptoms such as pain, fever and jaundice will indicate the need for further imaging including ultrasound, CAT scan, HIDA (hepato-iminodiacetic acid) scan and or MRCP (magnetic resonance cholangiopancreatography). Additional endpoints including time to identification of structures safety of the procedure and autonomy given to the residents using surveys will be included.
|Study Start Date:||January 2011|
|Study Completion Date:||August 2014|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: ICG injection with Spyscope imaging
50 patients will be randomized to the treatment group arm. They will receive ICG injection prior to surgery and imaged intraoperatively using the NIR (near infrared) camera (Spyscope)The Spyscope will be used to perform the cholecystectomy providing standard white light and NIR imaging
Drug: Indocyanine Green (ICG)
Injection of ICG intravenously then intraoperative imaging of the biliary anatomy during laparoscopic cholecystectomy using a near infrared (NIRF) imaging camera(Spy scope, Novadaq Canada)
Other Name: Spy scope
No Intervention: Standard Critical View Technique
50 patients will be randomized to the no treatment arm. These patients will not get ICG injection but rather will have the standard technique for laparoscopic cholecystectomy performed including the critical view technique to expose the important structures prior to clipping and division.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01424215
|United States, New York|
|Maimonides Medical Center|
|Brooklyn, New York, United States, 11219|