Fluorescent Cholangiography vs White Light for Bile Ducts Identification
Efficacy Of Near Infrared Incisionless Fluorescent Cholangiography (NIFC) During Laparoscopic Cholecystectomy
1 other identifier
interventional
677
5 countries
7
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2016
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2016
CompletedFirst Posted
Study publicly available on registry
March 9, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedResults Posted
Study results publicly available
November 12, 2025
CompletedNovember 12, 2025
October 1, 2025
1.8 years
February 17, 2016
May 5, 2020
October 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Detection Rate of Common Bile Duct Before and After Dissection Using Near Infra-red Light
Detection rate of the common bile duct during laparoscopic cholecystectomy, defined as the proportion of patients in whom the common bile duct was visualized immediately before dissection (baseline) and immediately after dissection using near infrared light. The detection rate was calculated separately for each arm and reported as the percentage of patients with successful identification.
Immediately before dissection (baseline) and immediately after dissection during the same surgical procedure.
Study Arms (2)
Xenon Light
ACTIVE COMPARATORLaparoscopic cholecystectomy with Xenon Light
Near infrared light
EXPERIMENTALLaparoscopic cholecystectomy with Near infrared light
Interventions
Standard laparoscopic cholecystectomy with white light
Laparoscopic cholecystectomy in infrared light after injection of indocyanine green pre-operatively.
Eligibility Criteria
You may qualify if:
- Patients of both genders
- Minimum age: 18 years old
- Spoken and written command of the language spoken in the country's center
- Ability to understand and follow the study procedures and sign the informed consent
You may not qualify if:
- Known allergies to iodides
- Known history of coagulopathy
- Known moderate or severe liver disease Women who are pregnant or breastfeeding, or for whom possibility of pregnancy was not ruled out
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Cleveland Cliniclead
- Cedars-Sinai Medical Centercollaborator
- Tokyo Medical Universitycollaborator
- Asklepios Kliniken Hamburg GmbHcollaborator
- Università degli Studi dell'Insubriacollaborator
- University of Rostockcollaborator
- Hospital de Clinicas José de San Martíncollaborator
Study Sites (7)
Cedar Sinai
Los Angeles, California, 90048, United States
Cleveland Clinic
Cleveland, Ohio, 44195, 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
Related Publications (1)
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.
PMID: 30614881DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lo Menzo, M.D.,Emanuele
- Organization
- Cleveland Clinic Florida
Study Officials
- PRINCIPAL INVESTIGATOR
Raul Rosenthal, MD
Cleveland Clinic Florida
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 17, 2016
First Posted
March 9, 2016
Study Start
April 1, 2016
Primary Completion
December 31, 2017
Study Completion
August 31, 2018
Last Updated
November 12, 2025
Results First Posted
November 12, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
Redcap will be used Data to be shared - pre-operative data including age, sex, laboratory values and imaging, intra-operative data including visualization of the extra-hepatic biliary structure with white light and with infrared light by the operating surgeon and the observer, any bile leak; post-operative data documenting any complications such as reaction to ICG or bile duct injury. Data will be available as each center finishes up the follow of each individual patient (usually 2 weeks post operatively). Each center will update the data on Redcap on a monthly basis. Data will be initially obtained on a pre-decided forms (approved by the IRB committee) and transferred to Redcap for electronic record keeping and analysis.