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

Not Applicable

• Conditions: Colon Cancer
• Interventions: Procedure: lymphatic mapping with indocyanine green

• Registration Number: NCT05468827
• Lead Sponsor: N.N. Petrov National Medical Research Center of Oncology

Brief 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

Detailed 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.

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-21
• Study Start: 2022-07-26
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-12
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
interventional	lymphatic mapping with indocyanine green	lymphatic mapping by indocyanine green

Primary Outcome Measures

Name	Time	Method
proportion of pN+ patients in which affected lymph nodes are detected only within margins of ICG distribution	30 days	number of patients with affected lymph nodes located within ICG distribution margins divided by the number of all patients with pN+

Secondary Outcome Measures

Name	Time	Method
incidence of adverse events related to ICG lymphatic mapping	30 days	proportion of patients facing adverse events related to ICG lymphatic mapping procedure
feasibility of ICG lymphatic mapping for colon cancer	duration of surgical procedure	proportion of ICG spillage affecting interpretation
incidence of lymph node metastases outside conventional resection margins (10 cm)	30 days	proportion of patients with aberrant lymphatics leading to affected lymph nodes
colon cancer lymphatic spread pattern	30 days	descriptive data on incidence of D1, D2 and D3 lymphatic collector metastases and frequences of D1 collector metastases depending on distance from primary tumour
feasibility of ICG mapping for colon flexure tumours	duration of surgical procedure	proportion of operations for colon flexure tumours which extent is effected by ICG lymphatic mapping

Trial Locations

Locations (1)

N.N. Petrov National Medical Research Center of Oncology; 🇷🇺 Saint Petersburg, Russian Federation