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NCT Number: NCT07303231

The Value of Indocyanine Green-guided Near-infrared Fluorescence Technology in Tracing Sentinel Lymph Nodes During Esophagectomy

Sentinel lymph nodes, as the primary site of tumor metastasis, play a pivotal role in assessing patient prognosis and planning subsequent treatment strategies. The investigators plan to conduct a multicenter, prospective cohort study to evaluate the effectiveness of indocyanine green (ICG)-guided near-infrared imaging in tracing sentinel lymph node during esophageal squamous cell carcinoma (ESCC) surgery, compared with the gold standard of complete lymph node dissection (CLND), in detecting metastatic disease. This study aims to address the following core questions:

1. In ESCC patients undergoing surgery, can sentinel lymph node biopsy reduce unnecessary lymph node dissection? 2. In ESCC patients undergoing surgery, can reducing lymph node dissection decrease postoperative complications such as chylothorax and weakened immunity? During the study, ICG will be injected around the tumor under intraoperative gastroscopy guidance, followed by tracking of fluorescent lymph nodes using a thoracoscopic near-infrared camera. Professional thoracic surgeons will group and mark these lymph nodes for intraoperative frozen pathology. Subsequent CLND and routine postoperative pathology will be performed. This study will collect patients' clinical information, ICG imaging results, pathological examination results, and other data for statistical analysis to assess the sensitivity and negative predictive value (NPV) of the ICG imaging system. If the study results support the effectiveness of the ICG imaging system, it has the potential to become an important tool for sentinel lymph node localization and biopsy in future ESCC surgeries, helping to reduce unnecessary lymph node resection and improve surgical efficiency and safety.

Participants will:

1. Undergo minimally invasive ESCC surgery within 2 weeks of enrollment, including the 14th day. 2. Receive ICG injection around the tumor under intraoperative gastroscopy guidance during surgery. 3. Have perioperative, postoperative pathology, and complication information recorded. 4. Undergo standardized follow-up after surgery.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Indocyanine Green Lymphadenectomy Neoplasms Neoplasms by Site Sentinel Lymph Node

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

This study will be accepted in esophageal cancer patients with Radical Esophag-ectomy as the research object. The investigators will divide participants into two groups: experimental group for injection of indocyanine green group and control group for injectable in-docyanine green group.The investigators will compare with the accuracy,false positive rate and false negative rate,sensitivity, specificity and related indicators of intraoperative lymph node cleaning,in order to explore the common position of esophageal cancer sentinel lymph node,guidance of esophageal cancer lymph node cleaning thoroughly.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age and gender: 18-75 years old, male and female unlimited;
  • Preoperative biopsy was pathologically diagnosed as esophageal squamous cell carcinoma;
  • Preoperative combination with neoadjuvant chemoradiotherapy;
  • Surgical resection of esophageal carcinoma under endoscopic selection and intraoperative anastomosis;
  • Heart, lung, liver and kidney functions can tolerate operation;
  • Patients and their family members can understand and are willing to participate in this clinical study and sign the informed consent.

Exclusion criteria

  • Allergic to ICG or iodine;
  • Patients with a history of chest surgery or thoracic lymph node dissection;
  • Patients needing emergency surgery;
  • Patients whose tumors involve neighboring organs and need to be removed by combining organs;
  • Patients with tumor recurrence or distant metastasis;
  • Patients who had participated in or were participating in other clinical trials within the previous 4 weeks were included;
  • A history of serious mental illness;
  • Pregnant or lactating women;
  • Patients with other conditions considered by the researcher should not participate in the study.

Treatment and study plan

Minimally invasive surgery for esophageal cancer using near-infrared indocyanine green fluorescence to visualize the sentinel lymph node

Drug

A multicenter, prospective cohort study will be conducted. Enrolled patients with esophageal squamous cell carcinoma will undergo minimally invasive radical esophagectomy. During surgery, ICG will be injected around the tumor under gastroscopy guidance, and fluorescent lymph nodes will be tracked using a thoracoscopic near-infrared camera. These lymph nodes will be grouped and marked by professional thoracic surgeons, and intraoperative frozen pathology results will be recorded. Subsequent CLND will be performed. The study will collect and analyze patients' clinical information, ICG imaging results, and pathological examination results to explore the effectiveness of the ICG imaging system.

Primary outcomes

  1. Accuracy rate of lymph node dissection

    Time frame: 1 week after operation

    According to postoperative pathological results, investigate the detection rate of metastatic lymph nodes using the near-infrared indocyanine green fluorescence imaging system in lymph node dissection for esophageal squamous cell carcinoma

Secondary outcomes

  1. Sensitivity and specificity of lymph node dissection

    Time frame: 1 week after operation

    Sensitivity and specificity of lymph node dissection of each arm（according to postoperative pathology）

  2. The number of lymph nodes

    Time frame: 1 week after operation

    The number of lymph nodes between the both groups

  3. False positive rate of lymph node dissection

    Time frame: 1 week after operation

    False positive rate of lymph node dissectionof each arm（according to postoperative pathology）

  4. False negative rate of lymph node dissection

    Time frame: 1 week after operation

    False negative rate of lymph node dissection of each arm（according to postoperative pathology）

Study contacts

Contact information is provided by the study sponsor or research team.

Bin Zheng, M.D.

CONTACT

[email protected]

15959002753

Jianting Du, M.D., Ph.D

CONTACT

[email protected]

13023806690

Sponsors and collaborators

Lead sponsor

Fujian Medical University Union Hospital

Other

Collaborators

  • Henan Cancer Hospital
  • The First Affiliated Hospital of Xiamen University
  • The University of Hong Kong

Registry information

Official study title

The Value of Indocyanine Green-guided Near-infrared Fluorescence Technology in Tracing Sentinel Lymph Nodes During Esophagectomy: A Multicenter Prospective Cohort Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

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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