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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. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

200

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: ICG-guided sentinel lymph node dissection only plus esophagectomy
The experimental group will undergo sentinel lymph node dissection only plus esophagectomy
Arzneimittel: 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.
Aktiver Komparator: ICG-guided systematic lymph node dissection plus esophagectomy
The control group will undergo conventional lymph node dissection plus esophagectomy
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
3-year Disease free survival rate
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Postoperative complications
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 3-year after surgery
3-year Overall Survival rate
3-year after surgery
Diagnostic performance of ICG
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Fujian Medical University Union Hospital

Mitarbeiter

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

Ermittler

  • Hauptermittler: Bin Zheng, Fujian Medical University Union Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2028

Studienabschluss (Geschätzt)

1. Oktober 2031

Studienanmeldedaten

Zuerst eingereicht

18. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. August 2026

Zuerst gepostet (Tatsächlich)

26. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. August 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • SIGN study

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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