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

Last updated: October 10, 2022
Sponsor: N.N. Petrov National Medical Research Center of Oncology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colorectal Cancer

Colon Cancer

Treatment

N/A

Clinical Study ID

NCT05468827
ISC-1
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 100
Study Start date:
July 26, 2022
Estimated Completion Date:
July 31, 2024

Study 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.

Connect with a study center

  • N.N. Petrov National Medical Research Center of Oncology

    Saint Petersburg, 192289
    Russian Federation

    Active - Recruiting

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