ICG Fluorescence Guided Lymph Node Mapping for Determination of Bowel Resection Margins in Colon Cancer (ISCAPE)

  • STATUS
    Recruiting
  • End date
    Jul 21, 2024
  • participants needed
    100
  • sponsor
    N.N. Petrov National Medical Research Center of Oncology
Updated on 21 October 2022

Summary

The study is aimed at investigating feasibility of defining colon resection margins for colon cancer with ICG by comparing lymphatic distribution of subserosally injected dye with actual spread of lymphatic metastases reported by pathologists after specimen examination

Description

In this study 2.5 mg/ml indocyanine green solution is injected subserosally into colonic wall near the tumour in 4 points (1 ml each). The fluorescence is assessed before specimen removal (at least 30 min after injection) and its mesenteric distribution is marked by surgeon on the specimen. Proximal and distal colonic resection margins are chosen to be at least 10 cm long and to include the whole area of fluorescence. After removal, lymphatic node groups according JSCCR are also marked on fresh specimen. During pathological examination each lymph node is assessed not only for presence of metastases but also for its exact location in relation to margins of indocyanine distribution.

Details
Condition Colon Cancer
Treatment lymphatic mapping with indocyanine green
Clinical Study IdentifierNCT05468827
SponsorN.N. Petrov National Medical Research Center of Oncology
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Pathologically confirmed adenocarcinoma of colon (caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid)
TNM T1-4a N0-2 M0-1
Clinical indications to colonic resection
ECOG - 0-2
Signed informed consent

Exclusion Criteria

Medical or psychiatric reasons interfering with patient's decision to participate in the study
Pregnancy or breastfeeding
Medical conditions contraindicating surgical procedure
Acute bowel obstruction, bleeding or perforation
Hypersensitivity to indocyanine green, sodium iodide or iodine
Hyperthyroidism or autonomic thyroid adenomas
Kidney failure of any aetiology
Hepatic failure of any aetiology
Poorly tolerated indocyanine injection in the past
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