Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery

NCT ID: NCT03579199

Last Updated: 2019-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-18

Study Completion Date

2021-10-31

Brief Summary

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"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."

Detailed Description

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"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."

Conditions

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Liver Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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exploration of abdominal cavity using a NIR/ICG camera

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Interventions

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

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FLUOPTICS

UNKNOWN

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hépato Biliaire de l'hopital Paul Brousse

Villejuif, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Eric Vibert, PhD

Role: CONTACT

1 45 59 30 36 ext. +33

Marc-Antoine Allard

Role: CONTACT

Facility Contacts

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Eric Vibert, PhD

Role: primary

1 45 59 30 36 ext. +33

Marc Antoine ALLARD

Role: backup

Other Identifiers

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2017-A02807-46

Identifier Type: OTHER

Identifier Source: secondary_id

P170105J

Identifier Type: -

Identifier Source: org_study_id

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