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

23 augustus 2026 bijgewerkt door: Fujian Medical University Union Hospital

Indocyanine Green-guided Sentinel Lymph Node Dissection Versus Systematic Lymph Node Dissection in cN0 Esophageal Squamous Cell Carcinoma: a Multicenter, Prospective, Non-inferiority Randomized Controlled Trial

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This study will enroll patients with cT1-3N0M0 esophageal cancer who have not received neoadjuvant therapy. If intraoperative frozen section shows negative sentinel lymph nodes, patients will be randomly assigned into two groups: the experimental group will undergo sentinel lymph node dissection only plus esophagectomy, while the control group will undergo conventional lymph node dissection plus esophagectomy. The investigators will compare the 3-year disease-free survival rate, postoperative complication rate, and other outcomes between the two groups 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.

Studietype

Ingrijpend

Inschrijving (Geschat)

200

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Fujian Medical University Union Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria

  1. Aged 18 to 75 years, regardless of gender;
  2. Histopathologically confirmed esophageal squamous cell carcinoma or adenocarcinoma by endoscopic biopsy (including esophagogastric junction carcinoma, Siewert type I/II);
  3. Preoperative clinical stage cT1-3N0M0 (based on contrast-enhanced CT ± PET-CT ± endoscopic ultrasound evaluation);
  4. No prior neoadjuvant therapy of any form (including chemotherapy, radiotherapy, chemoradiotherapy, immunotherapy, targeted therapy, etc.);
  5. Scheduled for minimally invasive radical esophagectomy (combined thoracoscopic and laparoscopic McKeown or Ivor-Lewis procedure);
  6. No surgical contraindications, with cardiac, pulmonary, hepatic, and renal functions sufficient to tolerate surgery;
  7. ECOG performance status score of 0 to 1;
  8. Written informed consent signed by the patient or legal representative.

Exclusion Criteria

  1. Preoperative imaging clearly indicating lymph node metastasis (cN+) or distant metastasis (cM1);
  2. Prior systemic or local treatment for esophageal cancer of any kind (including chemotherapy, radiotherapy, chemoradiotherapy, immunotherapy, etc.);
  3. Previous history of esophageal or gastric surgery (except endoscopic mucosal resection/submucosal dissection);
  4. History of allergy to iodine contrast agents or indocyanine green;
  5. Severe hepatic or renal insufficiency (Child-Pugh class B or C; serum creatinine ≥ 1.5 times the upper limit of normal);
  6. Uncontrolled hyperthyroidism;
  7. Concomitant other malignancies requiring simultaneous treatment;
  8. Pregnant or lactating women;
  9. Other conditions deemed unsuitable for enrollment by the investigator.

Withdrawal Criteria

  1. Intraoperative exploration revealing inability to achieve radical resection (R2 resection) or extensive thoracic and abdominal metastasis;
  2. Intraoperative exploration revealing definite lymph node metastasis (cN+) inconsistent with preoperative staging;
  3. Severe allergic reaction after ICG injection requiring discontinuation of the study;
  4. Intraoperative change of surgical plan due to severe complications;
  5. Withdrawal of informed consent by the patient.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: ICG-guided sentinel lymph node dissection only plus esophagectomy
The experimental group will undergo sentinel lymph node dissection only plus esophagectomy
Geneesmiddel: ICG-guided sentinel lymph node dissection
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.
Actieve vergelijker: ICG-guided systematic lymph node dissection plus esophagectomy
The control group will undergo conventional lymph node dissection plus esophagectomy
Geneesmiddel: ICG-guided systematic lymph node dissection
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
3-year Disease free survival rate
Tijdsspanne: 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.
3-year disease-free survival rate: defined as 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
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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Postoperative complications
Tijdsspanne: 30 days after surgery
The incidence of severe complications with Clavien-Dindo grade ≥ III within 30 days after surgery; the incidence of specific complications such as chylothorax, recurrent laryngeal nerve injury, anastomotic leakage, and pulmonary infection.
30 days after surgery
Immune status indicators
Tijdsspanne: Baseline (day -1), post-operative day 1, day 7, and month 1.
Immune status indicators: changes in peripheral blood lymphocyte subsets (CD4+, CD8+, NK cells) counts before and after surgery.
Baseline (day -1), post-operative day 1, day 7, and month 1.
lmmune status indicators
Tijdsspanne: Baseline (day -1), post-operative day 1, day 7, and month 1.
lmmune status indicators: changes in peripheral blood lymphocyte subsets (CD4+CD8+, NK cells) rates before and after surgery.
Baseline (day -1), post-operative day 1, day 7, and month 1.
3-year Overall Survival rate
Tijdsspanne: 3-year after surgery
3-year Overall Survival rate
3-year after surgery
Diagnostic performance of ICG
Tijdsspanne: 7-day after surgery
Diagnostic performance of ICG (using postoperative routine pathology as the gold standard): sensitivity, specificity, positive predictive value, negative predictive value, and false negative rate of ICG in identifying sentinel lymph nodes.
7-day after surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fujian Medical University Union Hospital

Medewerkers

The University of Hong Kong
Henan Cancer Hospital
Shengjing Hospital
Sichuan Cancer Hospital and Research Institute
The First Affiliated Hospital of Xiamen University
Zhangzhou Municipal Hospital of Fujian Province

Onderzoekers

  • Hoofdonderzoeker: Bin Zheng, Fujian Medical University Union Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 oktober 2028

Studie voltooiing (Geschat)

1 oktober 2031

Studieregistratiedata

Eerst ingediend

18 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 augustus 2026

Eerst geplaatst (Werkelijk)

26 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

23 augustus 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SIGN study

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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