Sentinel Lymph Node Mapping and Analysis in Colon Cancer Using Indocyanine Green Dye

Not Applicable

Completed

• Conditions: Colon Cancer
• Interventions: Procedure: sentinel lymph node mapping

• Registration Number: NCT04351009
• Lead Sponsor: Asian Institute of Gastroenterology, India

Brief Summary

Approximately 20-30 % of colon cancer patients who have no metastasis in lymph nodes after definitive colectomy have recurrence with distant metastasis. These recurrences could be due to missed occult tumor cells or micrometastasis. Detailed examination of all lymph nodes is expensive and time consuming. Sentinel lymph node mapping using Indocyanine green dye helps in identifying the lymph nodes which are most likely to harbour metastasis. These sentinel lymph nodes can be subsequently subjected to detailed pathologic examination and immunohistochemistry which increases the likelihood of identifying micrometastasis and occult tumor cells. Patients found to harbour such metastasis can be treated with additional chemotherapy after surgery. The aim of the study is to examine the feasibility of sentinel lymph node mapping using Indocyanine green dye in colon cancer and evaluate the upstaging rate in post-operative colon cancer patients who don't have metastatic lymph nodes on routine histopathology.

Detailed Description

All patients of colon cancer fulfilling the inclusion criteria and excluding the patients according to the exclusion criteria will undergo standard laparoscopic/open colectomy.

Indocyanine green dye is injected around the tumor in subserosal location for open surgeries and submucosally after on-table colonoscopy for laparoscopic surgeries and followed with near-infrared scope. Patients will undergo intra-operative on-table colonoscopy after induction of anesthesia. All sentinel nodes will be marked with clips/sutures for identification by the pathologist post-operatively. Any aberrant lymph nodes identified outside the planned resection margins will be excised, marked with the position of excision and sent separately from the gross specimen. After this the surgeon will proceed with the surgery including vascular ligation and resection of mesocolon.

After surgery, all the lymph nodes identified in the specimen including the tagged sentinel lymph nodes will be examined using standard Hematoxylin and eosin staining. If all the lymph nodes are negative for metastasis, the sentinel lymph nodes will undergo additional stepwise sections and immunohistochemistry for pancytokeratin.

Study Timeline

• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-17
• Study Start: 2020-06-08
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-03
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Indocyanine green sentinel lymph node mapping	sentinel lymph node mapping	Indocyanine green dye is injected in the submucosa or subserosa around the tumor to identify sentinel lymph nodes intra-operatively with near infrared fluorescence imaging.

Primary Outcome Measures

Name	Time	Method
Detection rate	2 years	Proportion of the number of successful sentinel lymph node procedures out of all executed sentinel lymph node procedures.
Upstaging rate	2 years	Sentinel lymph nodes in patients are pathologically node negative on routine evaluation with undergo detailed evaluation using serial sections and immunohistochemistry to identify micrometastasis and occult tumor cells. The proportion of node negative patients who are upstaged will be calculated.

Secondary Outcome Measures

Name	Time	Method
Accuracy	2 years	No of patients with successful sentinel lymph node mapping - False negatives/ No of patients with successful sentinel lymph node mapping.
Negative predictive value	2 years	number of patients in whom a negative sentinel lymph node correctly predicted the lymph node status of the total lymph node yield.
Aberrant lymph node drainage	2 years	proportion of sentinel lymph nodes identified outside planned resection margins and their tumor bearing status .

Trial Locations

Locations (1)

Asian Institute of Gastroenterology; 🇮🇳 Hyderabad, Telangana, India