Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Patients will undergo ICG injection and NIR imaging for lymphatic mapping. Any identified SLNs will be dissected during the standard completion lymphadenectomy and esophagectomy. The SLN biopsy procedure will be performed as described below. Although NIR with ICG is used to assess conduit perfusion in all esophagectomies performed at MSK, its use for lymphatic mapping is considered experimental in esophageal cancer.

Patients will receive a perilesional injection of indocyanine green (ICG) before the laparoscopic phase of the esophagectomy.

Injection of indocyanine green (ICG)dye

Real-time near-infrared (NIR) fluorescence imaging will be performed by use of the Novadaq PINPOINT minimally invasive system with a laparoscopic camera.

Near-Infrared Image-Guided

Any identified SLNs will be dissected during the standard completion lymphadenectomy and esophagectomy.

Sentinel Lymph Node (SLN) mapping

Daniela Molena, MD

Smita Sihag, MD, MPH

The purpose of this study is to find out whether sentinel lymph node (SLN) mapping with ICG dye and NIR imaging can be used to identify esophageal or esophagogastric junction cancer that has spread to the lymph nodes. If SLN mapping is successful in these types of cancer, surgeons in the future could identify the sentinel lymph nodes and only remove these instead of removing all the lymph nodes which is currently done.

This will be a prospective single-arm study.

Sentinel Lymph Node Mapping in Esophageal Cancer Using ICG Dye and NIR Imaging

Does the Concept of the Sentinel Lymph Node Apply to Esophageal Cancer? A Prospective Assessment of Near-infrared Image-guided Lymphatic Mapping and Sentinel Lymph Node Identification in Esophageal Cancer

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Surgical data will include the number of lymph nodes identified and removed both NIRfluorescent and NIR-nonfluorescent nodes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sentinel Lymph Node Mapping in Esophageal Cancer Using ICG Dye and NIR Imaging	NCT04400292	Esophageal Canc...	Injection of in... Near-Infrared I... Sentinel Lymph ...	18 Years -	Memorial Sloan Kettering Cancer Center
Sentinel Lymph Node Mapping in Esophageal Cancer Using ICG Dye and NIR Imaging	NCT04400292	Esophageal Canc...	Injection of in... Near-Infrared I... Sentinel Lymph ...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for injection of indocyanine green (icg)dye