The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01424215
Recruitment Status : Completed
First Posted : August 26, 2011
Last Update Posted : August 13, 2015
Information provided by (Responsible Party):
Maimonides Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cholelithiasis Cholecystitis Pancreatitis Biliary Colic of Gallbladder Without Mention of Cholecystitis Drug: Indocyanine Green (ICG) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy
Study Start Date : January 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ICG injection with Spyscope imaging
Indocyanine Green (ICG)
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.

Primary Outcome Measures :
  1. operative time [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 48hours ]
    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.

Secondary Outcome Measures :
  1. Safety of operative technique [ Time Frame: 0- 14 days Postoeprative ]
    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.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject is willing and able to provide an informed consent
  • Subject is willing and able to comply with the study procedures
  • Subject speaks English and is able to understand the study procedures
  • A pregnancy test for women of childbearing potential prior to surgery
  • Subject is scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

  • Subject has uremia, serum creatinine >2.5 mg/dl
  • Subject has a previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes
  • Subjects in whom the use of x-ray dye or ICG is contraindicated including development of adverse events when previously or presently administered
  • Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
  • Subject is a pregnant or lactating female
  • Subject is actively participating in another drug, biologic and/or device protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01424215

United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Maimonides Medical Center
Principal Investigator: Danny Sherwinter, MD Maimonides Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Maimonides Medical Center Identifier: NCT01424215     History of Changes
Other Study ID Numbers: 10/08/VA01
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Acalculous Cholecystitis
Pancreatic Diseases
Digestive System Diseases
Gallbladder Diseases
Biliary Tract Diseases
Pathological Conditions, Anatomical