Fluorescent Cholangiography vs White Light for Bile Ducts Identification
NCT ID: NCT02702843
Last Updated: 2025-11-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
677 participants
INTERVENTIONAL
2016-04-30
2018-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Xenon Light
Laparoscopic cholecystectomy with Xenon Light
Laparoscopic cholecystectomy with Xenon light
Standard laparoscopic cholecystectomy with white light
Near infrared light
Laparoscopic cholecystectomy with Near infrared light
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
Tokyo Medical University
OTHER
Asklepios Kliniken Hamburg GmbH
OTHER
Università degli Studi dell'Insubria
OTHER
University of Rostock
OTHER
Hospital de Clinicas José de San Martín
OTHER
The Cleveland Clinic
OTHER
Responsible Party
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Emanuele LoMenzo
Principal Investigator
Principal Investigators
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Raul Rosenthal, MD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic Florida
Locations
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Cedar Sinai
Los Angeles, California, United States
Cleveland Clinic
Cleveland, Ohio, United States
Hospital de clinicas jose de San Martin
Buenos Aires, , Argentina
Askelopios Westklinikum Hamburg
Hamburg, , Germany
Klinikum Sudstadt Rostock
Rostock, , Germany
University of Insubria
Varese, , Italy
University of Tokyo
Tokyo, , Japan
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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FLA 15-108
Identifier Type: -
Identifier Source: org_study_id