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Sentinel lymph node mapping and analysis in Colon cancer using Indocyanine green Dye

Intra-operative sentinel lymph node mapping using near-infrared fluorescence imaging by Indocyanine green dye in Colon cancer: prospective single center Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025791
Enrollment
32
Registered
2020-06-10
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C189- Malignant neoplasm of colon, unspecified

Interventions

Intervention1: Sentinel lymph node mapping using indocyanine green dye.: Sentinel lymph node mapping: Indocyanine green dye solution will be used. Injections (0.5-1 ml) will be given in the submucosa

Sponsors

Asian institute of gastroenterology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age at least 18 years old Biopsy proven colon cancer Scheduled for laparoscopic/open colectomy. All patients providing oral and written informed consent at Asian Institute of Gastroenterology, Hyderabad, Telangana.

Exclusion criteria

Exclusion criteria: Prior colorectal surgery. Gross lymph node involvement on pre-operative imaging or intra-operative staging. Advanced disease with invasion of adjacent structures, metastatic or T4 disease on preoperative imaging or discovered during intraoperative staging. Rectal cancer. Female participant who is pregnant, lactating or planning pregnancy during the course of the study. History allergy to any of the compounds being used for lymphatic mapping including indocyanine green, human albumin, iodides or shellfish. Patients with hyperthyroidism or thyroid adenoma. Patients undergoing purely palliative surgery. Advanced renal or hepatic insufficiency.

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study is to estimate detection rate of sentinel lymph nodes by using Indocyanine green dye in colon cancer patients.Timepoint: 1 month—

Secondary

MeasureTime frame
Accuracy:No of patients with successful SLN mapping - False negatives/ No of patients with successful SLN mapping.Timepoint: 1 month;Frequency and tumor status of aberrant lymph nodes: Proportion of Sentinel lymph nodes identified outside the planned resection margin and frequency of positivity for metastatic deposits.Timepoint: 1 month;Sensitivity of the sentinel lymph node biopsy procedure for detecting metastasisTimepoint: 1 month;Upstaging: Proportion of the patients upstaged from pathologically node negative to node positive after sentinel lymph node analysis.Timepoint: 1 month—

Countries

India

Contacts

Public ContactZeeshan Ahmed

Department of Surgical Gastroenterology, Asian Institute of Gastroenterology

drzeeshan180@gmail.com9873305835

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026