Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery

Liver Tumor Clinical Trial

— CAMVIC  

Official title:

Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03579199
• Other study ID #: P170105J
• Secondary ID: 2017-A02807-46
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: October 2021

Study information

• Verified date: April 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Eric Vibert, PhD
• Phone: 1 45 59 30 36
• Email: eric.vibert[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

"Indocyanine Green (ICG) is a dye used as an indicator of hepatic function considering its capacity to be eliminated only by the bile. Thus, ICG tend to remain in liver tumors.

The hypothesis of CAMVIC study is that the use of fluorescence imaging during laparoscopic hepatic surgery will allow to detect small subcapsular superficial lesions undetected by other diagnostic methods, which will improve the results of the oncologic treatment."

Description:

"Thanks to the property of ICG to release a fluorescent signal when excited by a Near Infra Red (NIR) light source, ICG fluorescence has been widely used during several clinical situations (angiography, lymphography,..). Few years ago it has been shown that hepatic tumors could be seen with a NIR camera able to view ICG fluorescence thanks to the depot in or around the tumor of the dye injected during preop.Since, this fluorescence imaging technique potential has been underlined to identify tumors undiagnosed before surgery. Pre-operative examination of hepatic lesions is based on 3 points:

• visual examination

• two-hand palpation

• intra-operative ultrasound.

During laparoscopic hepatic surgery it is not possible to palpate the liver thus peroperative examination of the liver surface is harder than during open surgery. Moreover per-operative ultrasound is not a reliable tool in order to explore liver surface. However the latest development of NIR cameras able to view ICG fluorescence could add a benefit in laparoscopic surgery in view of its capacity to detect superficial lesions, even those of small dimension."

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• men and woman aged of 18 yo and more

• patients with liver tumor

• patient affiliated to french social security

Exclusion Criteria:

• Patient unable to give a signed informed consent

• patient under guardianship or curator

• patient deprived of liberty by judicial or administrative decision or placed under judicial protection

• patient refusing to undergo the specific technique

• pregnant or lactating women

• patient with icteric cholestasis

• patient with contraindication to coelioscopy

• patient with known allergy to cyanines

• patient who must undergo staged hepatectomy

Related Conditions & MeSH terms

• Liver Neoplasms
• Liver Tumor

Intervention

Device:
• exploration of abdominal cavity and liver using a NIR/ICG camera
exploration of abdominal cavity and liver using a NIR/ICG camera

Locations

Country	Name	City	State
France	Centre Hépato Biliaire de l'hopital Paul Brousse	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	FLUOPTICS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of superficial nodules detected with the device during peroperative examination compared to the number of superficial nodules detected during preoperative imaging and new surface nodules detected at 6 month postoperative imaging	sensitivity will be assessed by the number of superficial nodules detected with the device during peroperative examination compared to the number of superficial nodules detected during preoperative imaging and new surface nodules detected at 6 month postoperative imaging	through study completion, an average of 6 months
Primary	Histological analysis of explanted liver parts	histological analysis will indicate the nature of the explanted part: tumoral tissue or healthy tissues. Results will be obtained during the month following the hepatectomy	1 month
Secondary	bilirubin and prothrombin levels	predictive value of the fluorescence dynamic on postoperative hepatic function will be assessed with bilirubin and prothrombin levels at day 1, day 3 and day 5 visits	at Day 1, day 3 and day 5 visits