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

A

Assistance Publique - Hôpitaux de Paris

Status

Unknown

Conditions

Liver Tumor

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03579199
P170105J
2017-A02807-46 (Other Identifier)

Details and patient eligibility

About

"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."

Full 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."

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 1 patient group

exploration of abdominal cavity using a NIR/ICG camera
Experimental group
Treatment:
Device: exploration of abdominal cavity and liver using a NIR/ICG camera

Trial contacts and locations

1

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Central trial contact

Marc-Antoine Allard; Eric Vibert, PhD

Data sourced from clinicaltrials.gov

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