Fluorescent Cholangiography vs White Light for Bile Ducts Identification

Summary

The Study is designed to compare the effectiveness of Near Infrared Fluorescence Cholangiography (NIFC) to standard white light imaging (WLI) in visualizing and identifying the main biliary and hepatic structures (Cystic Duct, Right Hepatic Duct, Common Hepatic Duct, Common Bile Duct, Cystic-CBD junction, Cystic-Gallbladder junction and any Accessory Ducts) during laparoscopic cholecystectomy. The aim is to demonstrate that NIFC performs better than standard white light (WLI) alone in visualizing and identifying extra-hepatobiliary structures (Cystic Duct, Right Hepatic Duct, Common Hepatic Duct, Common Bile Duct, Cystic-CBD junction, Cystic-Gallbladder junction, and any Accessory Ducts) before and after dissection during Laparoscopic Cholecystectomy (LC).

Conditions

• Cholecystitis
• Cholelithiasis

Interventions

PROCEDURE

Laparoscopic cholecystectomy with Xenon light

Standard laparoscopic cholecystectomy with white light

PROCEDURE

Laparoscopic cholecystectomy (fluorescent cholangiography)

Laparoscopic cholecystectomy in infrared light after injection of indocyanine green pre-operatively.

Sponsors & Collaborators

• Cedars-Sinai Medical Center

  collaborator OTHER

• Tokyo Medical University

  collaborator OTHER

• Asklepios Kliniken Hamburg GmbH

  collaborator OTHER

• Università degli Studi dell'Insubria

  collaborator OTHER

• University of Rostock

  collaborator OTHER

• Hospital de Clinicas José de San Martín

  collaborator OTHER

• The Cleveland Clinic

  lead OTHER

Principal Investigators

• Raul Rosenthal, MD · Cleveland Clinic Florida

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2017-12-31

Completion

2018-08-31

Countries

• United States
• Argentina
• Germany
• Italy
• Japan

Study Locations