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

N.N. Petrov National Medical Research Center of Oncology

Status: Enrolling

Conditions: Colon Cancer

Treatments: Procedure: lymphatic mapping with indocyanine green

Study type: Interventional

Funder types: Other

Identifiers

NCT05468827

ISC-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pathologically confirmed adenocarcinoma of colon (caecum, ascending colon, hepatic flexure, 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 criteria

1. Medical or psychiatric reasons interfering with patient's decision to participate in the 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

interventional

Experimental group

Description:

lymphatic mapping by indocyanine green

Treatment:

Procedure: lymphatic mapping with indocyanine green