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

NCT07303231 | Not Yet Recruiting Phase 3

• 1 other identifier: LYNX-ICG
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.In ESCC patients undergoing surgery, can sentinel lymph node biopsy reduce unnecessary lymph node dissection?
2. 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.
3. 3.Undergo minimally invasive ESCC surgery within 2 weeks of enrollment, including the 14th day.
4. 4.Receive ICG injection around the tumor under intraoperative gastroscopy guidance during surgery.
5. 5.Have perioperative, postoperative pathology, and complication information recorded.
6. 6.Undergo standardized follow-up after surgery.

Conditions

Esophageal Cancer; Sentinel Lymph Node; Lymphadenectomy; Indocyanine Green

Outcome Measures

Primary Outcomes (1)

• Accuracy rate of lymph node dissection

  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

  1 week after operation

Secondary Outcomes (4)

• Sensitivity and specificity of lymph node dissection

  1 week after operation

• The number of lymph nodes

  1 week after operation

• False positive rate of lymph node dissection

  1 week after operation

• False negative rate of lymph node dissection

  1 week after operation

Study Arms (2)

(ICG group) receiving VATS with near-infrared imaging with indocyanine green to visualize

EXPERIMENTAL

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

(Control group) receiving VATS without near-infrared imaging with indocyanine g

NO INTERVENTION

Interventions

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.

(ICG group) receiving VATS with near-infrared imaging with indocyanine green to visualize

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: collaborator
• The University of Hong Kong: collaborator
• Fujian Medical University Union Hospital: lead
• The First Affiliated Hospital of Xiamen University: collaborator

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Minimally Invasive Surgical Procedures

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Bin Zheng, M.D.

CONTACT

15959002753; lacustrian@163.com

Jianting Du, M.D., Ph.D

CONTACT

13023806690; dujt1220@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: December 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)