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

NCT ID: NCT04351009

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-08
• Study Completion Date: 2022-06-30

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.

Conditions

Colon Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Indocyanine green 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.

Group Type: EXPERIMENTAL

sentinel lymph node mapping

Intervention Type: PROCEDURE

Through on-table colonoscopy indocyanine green solution will be injected in the submucosa at 2-4 points around the tumor for laparoscopic surgeries. Dye will be injected in the subserosa at 2-4 points for open surgeries. Lymphatic flow from the tumor will be mapped in real time with near-infrared fluorescence imaging scope and sentinel lymph nodes will be identified.

Interventions

sentinel lymph node mapping

Through on-table colonoscopy indocyanine green solution will be injected in the submucosa at 2-4 points around the tumor for laparoscopic surgeries. Dye will be injected in the subserosa at 2-4 points for open surgeries. Lymphatic flow from the tumor will be mapped in real time with near-infrared fluorescence imaging scope and sentinel lymph nodes will be identified.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Age 18 years or older Biopsy proven colon cancer Scheduled for laparoscopic/open colectomy

Exclusion Criteria

Prior colorectal surgery Gross lymph node invasion on pre-operative imaging or intraoperative staging Advanced disease (T4 disease or metastasis) on preoperative imaging or intraoperative staging Allergy to iodide containing compounds, human albumin or Indocyanine green dye History of hyperthyroidism or thyroid adenoma Palliative surgery Advanced hepatic failure Advanced renal failure

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asian Institute of Gastroenterology, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanjeev M Patil, MS

Role: PRINCIPAL_INVESTIGATOR

Asian Institute of Gastroenterology

Locations

Asian Institute of Gastroenterology

Hyderabad, Telangana, India

Countries

India

Other Identifiers

ICG001

Identifier Type: -

Identifier Source: org_study_id