Clinical trial NCT02702843: Fluorescent Cholangiography vs White Light for Bile Ducts Identification
Official title: Efficacy Of Near Infrared Incisionless Fluorescent Cholangiography (NIFC) During Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystitis
Cholelithiasis
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Cedars-Sinai Medical Center
name: Tokyo Medical University
name: Asklepios Kliniken Hamburg GmbH
name: Università degli Studi dell'Insubria
name: University of Rostock
name: Hospital de Clinicas José de San Martín
First posted: 2016-03-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection Rate of extra-hepatobiliary structures using near infra-red light
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedar Sinai
state: California
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Buenos Aires
country: Argentina
facility: Hospital de clinicas jose de San Martin
city: Hamburg
country: Germany
facility: Askelopios Westklinikum Hamburg
city: Rostock
country: Germany
facility: Klinikum Sudstadt Rostock
city: Varese
country: Italy
facility: University of Insubria
city: Tokyo
country: Japan
facility: University of Tokyo
Study officials:
affiliation: Cleveland Clinic Florida
name: Raul Rosenthal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dip F, LoMenzo E, Sarotto L, Phillips E, Todeschini H, Nahmod M, Alle L, Schneider S, Kaja L, Boni L, Ferraina P, Carus T, Kokudo N, Ishizawa T, Walsh M, Simpfendorfer C, Mayank R, White K, Rosenthal RJ. Randomized Trial of Near-infrared Incisionless Fluorescent Cholangiography. Ann Surg. 2019 Dec;270(6):992-999. doi: 10.1097/SLA.0000000000003178.