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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- The number of lymph nodes visualized to be fluorescent and nonfluorescent.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnosis of adenocarcinoma tumor located in distal 1/3 of esophagus or esophagogastric junction , with a plan to undergo minimally invasive esophagectomy.
- •All patients with Stage IVA (AJCC Cancer Staging Manual, 8th edition) disease will be eligible
- •≥18 years of age.
- •Documented, signed, and dated informed consent, obtained before any procedures, for the proposed research study and for standard surgical resection.
排除标准
- •No plan to undergo surgical resection.
- •Severe iodide or seafood allergy.
- •Women of childbearing potential without a negative pregnancy test; or women who are lactating.
- •Prior diagnosis of severe hepatic or renal dysfunction.
- •Patients with Stage IVB or M1 disease (AJCC Cancer Staging Manual, 8th edition)
- •Patients with local recurrence and planning to undergo salvage esophagectomy
研究组 & 干预措施
SLN mapping by NIR with ICG
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.
干预措施: Injection of indocyanine green (ICG)dye (Other)
SLN mapping by NIR with ICG
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.
干预措施: Near-Infrared Image-Guided (Device)
SLN mapping by NIR with ICG
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.
干预措施: Sentinel Lymph Node (SLN) mapping (Procedure)
结局指标
主要结局
The number of lymph nodes visualized to be fluorescent and nonfluorescent.
时间窗: 1 year
Surgical data will include the number of lymph nodes identified and removed both NIRfluorescent and NIR-nonfluorescent nodes.
次要结局
未报告次要终点