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The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy

This study is currently recruiting participants.
Verified August 2011 by Maimonides Medical Center
Sponsor:
Information provided by (Responsible Party):
Maimonides Medical Center
ClinicalTrials.gov Identifier:
NCT01424215
First received: August 23, 2011
Last updated: August 25, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention
Cholelithiasis
Cholecystitis
Pancreatitis Biliary
Colic of Gallbladder Without Mention of Cholecystitis
 Drug: Indocyanine Green (ICG)
Drug: Standard critical view technique

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maimonides Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Bile duct injury [ Time Frame: 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 assesed 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 scan and or MRCP


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: Standard critical view technique
No injection will be used and only the standard laparoscopic cholecystectomy will be employed.
Other Name: No intervention

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  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424215

Contacts
Contact: Danny A Sherwinter, MD 7182837952 dsherwinter@maimonidesmed.org
Contact: J Fuzaylova, MA 7182837952 jfuzaylova@maimonidesmed.org

Locations
United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Sherwinter, MD     718-283-7952        
Principal Investigator: Danny A Sherwinter, MD            
Sponsors and Collaborators
Maimonides Medical Center
  More Information

No publications provided

Responsible Party: Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT01424215     History of Changes
Other Study ID Numbers: 10/08/VA01
Study First Received: August 23, 2011
Last Updated: August 25, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Gallbladder Diseases
Cholecystitis
Acalculous Cholecystitis
Cholelithiasis
Cholecystolithiasis
Gallstones
 Pancreatitis
Biliary Tract Diseases
Digestive System Diseases
Calculi
Pathological Conditions, Anatomical
Pancreatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013