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NCT Number: NCT04351009

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

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500082, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sentinel lymph node mapping

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.

Primary outcomes

  1. Detection rate

    Time frame: 2 years

    Proportion of the number of successful sentinel lymph node procedures out of all executed sentinel lymph node procedures.

  2. Upstaging rate

    Time frame: 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 outcomes

  1. Accuracy

    Time frame: 2 years

    No of patients with successful sentinel lymph node mapping - False negatives/ No of patients with successful sentinel lymph node mapping.

  2. Negative predictive value

    Time frame: 2 years

    number of patients in whom a negative sentinel lymph node correctly predicted the lymph node status of the total lymph node yield.

  3. Aberrant lymph node drainage

    Time frame: 2 years

    proportion of sentinel lymph nodes identified outside planned resection margins and their tumor bearing status .

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study title

Intra-operative Sentinel Lymph Node Mapping Using Indocyanine Green Dye Near-infrared Fluorescence Imaging in Colon Cancer: Prospective Single Center Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 17, 2020
Registry last updated
Jul 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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