Fluorescent Cholangiography vs White Light for Bile Ducts Identification

Cholecystitis Clinical Trial

Official title:

Efficacy Of Near Infrared Incisionless Fluorescent Cholangiography (NIFC) During Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702843
• Other study ID #: FLA 15-108
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: August 31, 2018

Study information

• Verified date: April 2019
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Recently, a novel technique to visualize structures using fluorescent light and intravenous dye has been developed.

Near Infrared Incisionless Fluorescent Cholangiography (NIFC) is a medical imaging technique that uses fluorescence to detect properly labeled structures during surgery.

NIFC is performed using imaging devices with the purpose of providing real-time simultaneous information from color reflectance images (white light) and fluorescence emission (near infrared light). One or more light sources are used to excite and illuminate the sample. Light is collected using optical filters that match the emission spectrum of the fluorophore. Imaging lenses and digital cameras are used to produce the final image.

During laparoscopic cholecystectomies, the visualization of the extra-hepatic bile ducts with fluorescence is called Near Infrared Incisionless Fluorescent Cholangiography (NIFC). Fluorescence equipment and a dye are necessary in order to perform a NIFC, but the technique requires no radiation or incision. A fluorescence dye is administrated intravenously at least 45 minutes before the surgery, which is excreted by the liver and the bile duct 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.

Eligible patients will be identified through clinical and test evaluation. Eligibility will be verified by the patient's primary surgeon. The surgeon will determine the indication and date of the surgery. Once a patient is confirmed as eligible, the surgeon will introduce the study in detail. If after being introduced to the study and having had the opportunity to ask questions, the patient is willing to participate, he/she will be asked to review and sign the informed consent document .

Upon entry in the clinical trial patients will be randomly allocated to the intervention arm. Data will be collected at enrolment time, during surgery, at the end of surgery and one week after surgery.

Upon entry in the clinical trial, the master study database (REDCap, will randomly allocated patients to one of the study arms (1:1) within site (1:1) using a computer generated random sequence. This will provide an allocation sequence for each site. Once a patient is enrolled and a database file in REDCap is initiated for that patient, he/she will be assigned electronically to one of the study arms.

Patient will be blind to the intervention but surgeon blinding will not be feasible due to the nature of the intervention. The study will involve a considerable number of surgeons in each site, which should compensate any potential bias of some of them in favor or against either approach.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: August 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients of both genders

2. Minimum age: 18 years old

3. Spoken and written command of the language spoken in the country's center

4. Ability to understand and follow the study procedures and sign the informed consent

Exclusion Criteria:

1. Known allergies to iodides

2. Known history of coagulopathy

3. Known moderate or severe liver disease Women who are pregnant or breastfeeding, or for whom possibility of pregnancy was not ruled out

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• Laparoscopic cholecystectomy with Xenon light
Standard laparoscopic cholecystectomy with white light
• Laparoscopic cholecystectomy (fluorescent cholangiography)
Laparoscopic cholecystectomy in infrared light after injection of indocyanine green pre-operatively.

Locations

Country	Name	City	State
Argentina	Hospital de clinicas jose de San Martin	Buenos Aires
Germany	Askelopios Westklinikum Hamburg	Hamburg
Germany	Klinikum Sudstadt Rostock	Rostock
Italy	University of Insubria	Varese
Japan	University of Tokyo	Tokyo
United States	Cleveland Clinic	Cleveland	Ohio
United States	Cedar Sinai	Los Angeles	California

Sponsors (7)

Lead Sponsor	Collaborator
The Cleveland Clinic	Asklepios Kliniken Hamburg GmbH, Cedars-Sinai Medical Center, Hospital de Clinicas José de San Martín, Tokyo Medical University, Università degli Studi dell'Insubria, University of Rostock

Countries where clinical trial is conducted

United States,  Argentina,  Germany,  Italy,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection Rate of extra-hepatobiliary structures using near infra-red light	Detection Rate of each particular extra-hepatobiliary structure during Laparoscopic Cholecystectomy defined as the total number of patients in which the particular structure is detected before and after dissection in that arm of the Study, divided by the total number of patients in that arm.	One year