Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery (CAMVIC)

• ClinicalTrials.gov Identifier: NCT03579199
• Recruitment Status: Unknown
• First Posted: July 6, 2018
• Last Update Posted: April 17, 2019
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: FLUOPTICS
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Study Description

Brief 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."

Condition or disease	Intervention/treatment	Phase
Liver Tumor	Device: exploration of abdominal cavity and liver using a NIR/ICG camera	Not Applicable

Detailed 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."

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery
• Actual Study Start Date: March 18, 2019
• Estimated Primary Completion Date: March 2021
• Estimated Study Completion Date: October 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: exploration of abdominal cavity using a NIR/ICG camera	Device: exploration of abdominal cavity and liver using a NIR/ICG camera; exploration of abdominal cavity and liver using a NIR/ICG camera

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: through study completion, an average of 6 months ]
   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
2. Histological analysis of explanted liver parts [ Time Frame: 1 month ]
   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

Secondary Outcome Measures :

1. bilirubin and prothrombin levels [ Time Frame: at Day 1, day 3 and day 5 visits ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Eric Vibert, PhD; 1 45 59 30 36 ext +33; eric.vibert@aphp.fr

Contact: Marc-Antoine Allard; marcantoine.allard@aphp.fr

Locations

France

Centre Hépato Biliaire de l'hopital Paul Brousse; Recruiting

Villejuif, France, 94800

Contact: Eric Vibert, PhD 1 45 59 30 36 ext +33 eric.vibert@aphp.fr

Contact: Marc Antoine ALLARD marcantoine.allard@aphp.fr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

FLUOPTICS

More Information

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT03579199
• Other Study ID Numbers: P170105J; 2017-A02807-46 ( Other Identifier: N° IDRCB )
• First Posted: July 6, 2018
• Last Update Posted: April 17, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:

hepatic tumor; liver; ICG; ICG camera; laparoscopy

Additional relevant MeSH terms:

Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases