Cholecystocholangiography by Direct Intragallbladder Injection of ICG

NCT03812432 | Unknown DMC

• 1 other identifier: XMOL16012019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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, a quantity of bile will be extracted from the gallbladder by puncture and the same amount of contrast will be introduced. During the intervention teh tissue wil be exposure 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

Cholecystectomy

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)

near-infrared cholecystocholangiography

EXPERIMENTAL

Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence. Once the fundus is grasped and retracted, a needle-tipped cholangiogram catheter is introduced through the skin, adjacent to gallbladder. The catheter, guided by a grasping or dissecting instrument, is used to puncture the infundibulum of the gallbladder. Nine milliliters of bile is aspirated from the gallbladder into a syringe and and a indocianine green solution is injected into the gallbladder. The catheter is removed and the puncture site pinched closed with a grasper. Dissection is then performed under either ambient light or near-infrared mode. The surgical view of the gallbladder dissection is toggled back and forth between the two viewing.

Device: Near-infrared fluorescence cholecystocholangiography

Interventions

Near-infrared fluorescence cholecystocholangiography DEVICE

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.

near-infrared cholecystocholangiography

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

Study Sites (1)

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 23, 2019
• Study Start: January 15, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 25, 2019

Record last verified: 2019-01

Locations

ES (1)