The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy

NCT01424215 | Completed Results DMC

• 1 other identifier: 10/08/VA01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholelithiasis; Cholecystitis; Pancreatitis Biliary; Colic of Gallbladder Without Mention of Cholecystitis

Outcome Measures

Primary Outcomes (1)

• Operative Time

  The primary endpoint will be operative time measured as the minutes from the beginning of the dissection until the gallbladder is separated entirely from the gall bladder fossa. Minutes from start of procedure until recognition of structures.

  participants will be followed for the duration of hospital stay, an expected average of 48hours

Secondary Outcomes (1)

• Identification of Structures

  0- 14 days Postoeprative

Study Arms (2)

ICG injection with Spyscope imaging

EXPERIMENTAL

Indocyanine Green (ICG)

Drug: Indocyanine Green (ICG)

Standard Critical View Technique

NO INTERVENTION

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.

Interventions

Indocyanine Green (ICG) DRUG

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)

Also known as: Spy scope

ICG injection with Spyscope imaging

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maimonides Medical Center: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (1)

• Sherwinter DA. Identification of anomolous biliary anatomy using near-infrared cholangiography. J Gastrointest Surg. 2012 Sep;16(9):1814-5. doi: 10.1007/s11605-012-1945-z. Epub 2012 Jul 3.

  PMID: 22752550 DERIVED

MeSH Terms

Conditions

Cholelithiasis; Cholecystitis

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Danny Sherwinter
• Organization: Maimonides

dsherwinter@maimonidesmed.org

7182837952

Study Officials

• Danny Sherwinter, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending, Surgery

Study Record Dates

• First Submitted: August 23, 2011
• First Posted: August 26, 2011
• Study Start: January 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 12, 2020
• Results First Posted: May 12, 2020

Record last verified: 2020-05

Locations

US (1)