NIR Fluorescence Cholangiography With Low Dose of ICG

NCT04005898 | Unknown

• 1 other identifier: XMOLICGEV
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this clinical trial is to visualize the bile ducts by injecting a contrast that is only visible with infrared light. For this, we administrate an intravenous low dose of ICG before a cholecystectomy. During the intervention the tissue will be exposed to infrared light to visualize the bile ducts. This technique aims to increase safety in surgery to avoid damaging bile or vascular structures during gallbladder interventions.

Conditions

Cholecystitis/Cholelithiasis

Outcome Measures

Primary Outcomes (1)

• Visualization of the cystic duct, common hepatic duct, common bile duct and cysticocholedochal junction.

  Percentage of patients for whom fluorescence allows visualize cystic duct, common hepatic duct, common bile duct and cysticocholedochal junction with precision. cysticocholedochal junction.

  Intra-operatively

Study Arms (1)

Experimental: near-infrared cholangiography

EXPERIMENTAL

Each subject included in the study will be subjected to a fluorescence cholangiography. The control group will be the same patient. The study consists of knowing if fluorescence is able to visualize structures that are not seen with the naked eye. For this purpose the structures are visualized with normal light and then with infrared light of the same patient. During laparoscopic cholecystectomy it will change between normal and infrared light.

Device: Near-infrared fluorescence cholangiography

Interventions

Near-infrared fluorescence cholangiography DEVICE

Real-Time Fluorescence Imaging (VISERA ELITE II Imaging System). These device is used to identify anatomy, using infrared light that causes the indocianine green to fluoresce.

Experimental: near-infrared cholangiography

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for elective laparoscopic cholecystectomy.
• Normal liver and renal function.
• No hypersensitivity for iodine or indocianine green.
• Able to understand nature of the study procedures.
• Willing to participate and with written informed consent.

You may not qualify if:

• Age \< 18 years.
• Liver or renal insufficiency.
• Known iodine or indocianine green hypersensitivity.
• Pregnancy or breastfeeding.
• Not able to understand nature of the study procedure.

Sponsors & Collaborators

• Hospital Son Espases: lead

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: 30614881 BACKGROUND

MeSH Terms

Conditions

Cholecystitis; Cholelithiasis

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Francesc Xavier Molina, PhD

CONTACT

0034871205000; xmolina@ssib.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2019
• First Posted: July 2, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: June 1, 2022
• Last Updated: July 2, 2019

Record last verified: 2019-06