A Non-inferiority Study of Indocyanine Green-guided Sentinel Lymph Node Mapping Versus Conventional Lymph Node Dissection in Esophageal Cancer

Sponsor
Fujian Medical University Union Hospital
Study ID
NCT07788001
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Disease Free Survival
  • Esophageal Cancer
  • Indocyanine Green (ICG)
  • Lymphadenectomy
  • Sentinel Lymph Node

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ICG-guided sentinel lymph node dissection — DRUG
    In the experimental group, the investigators will perform only sentinel lymph node dissection and esophagectomy, without further lymph node resection. This intervention is distinguished by its de-escalated surgical approach: unlike conventional radical esophagectomy with systematic lymph node dissection, no additional lymph node stations will be removed beyond the identified sentinel lymph nodes. By preserving non-sentinel regional lymph nodes, this strategy aims to reduce surgical trauma and postoperative complications-such as chylothorax and recurrent laryngeal nerve injury-while maintaining oncological safety in patients with cT1-3N0M0 esophageal squamous cell carcinoma.
  • ICG-guided systematic lymph node dissection — DRUG
    In the control group, in addition to dissecting the sentinel lymph nodes, the investigators will proceed with standard two-field or three-field lymph node dissection for esophageal cancer.

Study Details

In the comprehensive treatment system for esophageal cancer, surgical resection combined with regional lymph node dissection remains the core component for achieving cure in patients with resectable esophageal squamous cell carcinoma (ESCC). The traditional surgical concept holds that the more thorough the lymph node dissection, the better. However, increasing basic and clinical evidence indicates that lymph nodes without metastasis-particularly tumor-draining lymph nodes-play an irreplaceable role in maintaining the host's anti-tumor immune response. Preclinical studies have found that radiation exposure to tumor-draining lymph nodes can impair the efficacy of radiotherapy combined with immunotherapy. In the surgical field, this shift in understanding has given rise to an important clinical question: in radical esophagectomy for esophageal cancer, is it possible to maximally preserve non-metastatic normal lymph nodes while ensuring complete removal of metastatic lymph nodes? If achievable, patients may not only benefit from reduced postoperative complications (such as chylothorax and recurrent laryngeal nerve injury) but also retain important immune organ function, providing a stronger basis for subsequent immunotherapy responses. Therefore, this study intends to conduct a multicenter, prospective, randomized controlled, non-inferiority trial in patients with cT1-3N0M0 esophageal squamous cell carcinoma who have not received neoadjuvant therapy, to evaluate the oncological safety of sentinel lymph node dissection based on the ICG near-infrared fluorescence imaging system in radical esophagectomy for esophageal cancer. 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. If intraoperative frozen section shows negative sentinel lymph nodes, patients will be randomized 1:1 into two groups: one group will undergo esophagectomy alone without further lymph node dissection, while the other group will undergo conventional lymph node dissection plus esophagectomy. The primary objective of this study is to evaluate the non-inferiority of ICG-guided sentinel lymph node dissection compared with conventional systematic lymph node dissection in terms of 3-year disease-free survival in patients with cT1-3N0M0 esophageal squamous cell carcinoma who have not received neoadjuvant therapy, thereby validating the oncological safety of the sentinel lymph node dissection strategy. 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.

Key Dates

First listed
Aug 26, 2026
Start date
Oct 1, 2026
Status verified
Jun 2026
Primary completion
Oct 1, 2028
Completion
Oct 1, 2031

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ICG-guided sentinel lymph node dissection only plus esophagectomy
    The experimental group will undergo sentinel lymph node dissection only plus esophagectomy
  • Active Comparator: ICG-guided systematic lymph node dissection plus esophagectomy
    The control group will undergo conventional lymph node dissection plus esophagectomy

Primary Outcome Measure

3-year Disease free survival rate [ Time Frame: The time from randomization to the first occurrence of any of the following events (local recurrence, regional lymph node recurrence, distant metastasis, or death from any cause), assessed up to 36 months. ]

Central Contacts

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