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Clinical Study on Using Laparoscopic Sentinel Lymph Node Navigation Combined With Dual Endoscopy Surgery for Early Gastric Cancer

2 octobre 2026 mis à jour par: wangdongsheng

Safety and Effectiveness of Laparoscopic Sentinel Lymph Node Navigation Combined With Dual-endoscope Surgery for Early Stomach Cancer: a Prospective, Single-centre, Single-arm Clinical Study

Gastric cancer is a common malignant tumour worldwide, and in China, the incidence and mortality rates of gastric cancer remain high. Standardised surgical treatment is effective, but the normal structure of the stomach undergoes irreversible changes, leading to a series of adverse reactions. At the same time, some early-stage gastric cancer patients cannot have the lesions completely removed endoscopically, and conventional surgery can affect postoperative normal life. Therefore, laparoscopic and endoscopic cooperative surgery has become a focus for precise stomach-preserving surgery. Participants meeting the surgical criteria are selected, and after discussing the treatment plan with their families and signing informed consent forms, relevant examinations are completed. During surgery, lesions are explored together using laparoscopy and endoscopy, then a fluorescent tracer is injected around the lesion and the lesion boundary is marked. Fifteen minutes after injecting the fluorescent tracer, the illuminated perigastric lymph nodes are the sentinel lymph node region (SLNB), and all fluorescent lymph nodes (sentinel lymph nodes) are removed and sent for intraoperative frozen pathology. If the SLNB is negative: a dual-endoscope combined local gastric resection (endoscope combined with laparoscopic local gastric resection or a modified procedure) is performed to completely remove the lesion, ensuring a negative margin. If the SLNB is positive: immediate conversion to laparoscopic-assisted radical gastrectomy (D2 lymph node dissection) is carried out. For SLNB-negative cases, the dual-endoscope combined local gastric resection specimen is placed in a retrieval bag for full removal and examination, with the stomach wall incision then closed by suturing or using a stapler. Postoperative follow-up includes monitoring tumour outcomes and quality of life.

Aperçu de l'étude

Description détaillée

Stomach cancer is one of the common malignant tumours worldwide, and in China, the incidence and mortality rates of stomach cancer remain high, posing a major public health burden. With the widespread implementation of stomach cancer screening in China, the detection rate of early-stage stomach cancer has significantly increased, now accounting for 19.5% of all stomach cancer cases. Early-stage stomach cancer (T1 stage) has a much better prognosis than advanced-stage cancer, with a 5-year survival rate exceeding 90% after standard treatment. Endoscopic submucosal dissection (ESD), due to its minimally invasive nature and ability to preserve stomach function, has become the standard treatment for certain cT1a-stage stomach cancers. However, for early-stage stomach cancer patients with a higher risk of lymph node metastasis, the lymph node metastasis rate can be close to 20%. In this context, if these patients only undergo endoscopic removal, they may face a higher risk of tumour residue. The traditional standard treatment is radical gastrectomy, usually combined with regional lymph node dissection (D1 or D2). Although this surgery is effective for cancer control, it can cause significant trauma, leading to irreversible changes to the patient's post-operative physiology and function, as well as long-term complications such as malnutrition, reflux oesophagitis and reduced quality of life, which have become key issues affecting the recovery of early-stage stomach cancer patients.

With the development of endoscopic technology (gastroscopy) and laparoscopic minimally invasive surgery, the concept of "function-preserving" surgery for early gastric cancer has been gaining increasing attention. This concept aims to minimise surgical trauma and preserve the anatomical structure and physiological function of the stomach while ensuring oncological safety. Achieving this goal relies heavily on the development and integration of two key techniques. First is Laparoscopic Sentinel Node Navigation Surgery (LSNNS). Sentinel lymph nodes are the first or group of lymph nodes along the primary tumour's lymphatic drainage pathway, and their pathological state is considered to highly predict metastasis in all lymph nodes in that region. In gastric cancer surgery, by injecting tracers (such as the fluorescent dye indocyanine green) under the mucosa around the tumour, and using the magnified view and fluorescence imaging system of laparoscopy, these sentinel lymph nodes can be located and removed in real time for intraoperative rapid pathological examination. The National Cancer Center in South Korea conducted a multicentre phase III randomised controlled clinical trial (SENORITA) on laparoscopic sentinel node navigation surgery for function-preserving surgery in early gastric cancer. In the LSNNS group, 210 patients (81%) underwent stomach-preserving surgery, and the results showed no significant difference in postoperative complication rates, 5-year local recurrence, disease-free survival (DFS), and overall survival (OS) compared to conventional laparoscopic radical gastrectomy. However, the LSNNS group had significantly better postoperative quality of life. These study results suggest that due to the complexity of gastric cancer lymphatic drainage and the skip and uncertain nature of metastasis, detecting the sentinel lymphatic basin (SLB) can provide a more comprehensive understanding of sentinel nodes, offering precise guidance for individualised lymph node dissection and avoiding unnecessary extended lymph node removal, reducing surgical trauma and related complications without compromising oncological outcomes.

Laparoscopic and endoscopic cooperative surgery (LECS) combines the advantages of laparoscopic internal view and operation with the precise localisation and removal capabilities of endoscopy. It's become a hot research topic in stomach-function-preserving surgery in recent years. Endoscopy provides a high-definition view of the mucosal surface from inside the cavity, allowing precise marking of tumour boundaries and submucosal dissection, while laparoscopy offers an external view of the serosal surface, enabling reliable full-thickness gastric wall resection, accurate suturing and regional lymph node inspection and management. Main LECS procedures include laparoscopic-assisted endoscopic full-thickness resection (LAEFR), endoscope-assisted wedge resection (EAWR), classic LECS and modified LECS. Several studies both domestic and international have shown LECS has advantages in treating various gastrointestinal tumours, but standardised procedures for early gastric cancer are not yet established, and current data is largely from retrospective studies, lacking high-quality prospective evidence.

Type d'étude

Interventionnel

Inscription (Estimé)

9

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

    • Shandong
      • Qingdao, Shandong, Chine, 266000
        • Inscription sur invitation
        • Qingdao University Affiliated Hospital West Coast Campus
      • Qingdao, Shandong, Chine, 266011
        • Recrutement
        • Gastrointestinal Surgery at Qingdao University Affiliated Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. Gastroscopy biopsy confirmed a solitary gastric adenocarcinoma;
  2. White light endoscopy, magnifying endoscopy-image-enhanced endoscopy,(ME-IEE), endoscopic ultrasound and enhanced CT comprehensively assessed as cT1N0M0, with no distant metastasis;
  3. Assessed by MDT as unsuitable for simple ESD: including cases beyond the current guideline/consensus recommended ESD curative resection indications, or although at the endoscopic treatment border, significant fibrosis, scarring, non-lifting and other factors make complete endoscopic resection difficult and surgical function-preserving treatment has reasonable benefits;
  4. Lesion maximum diameter in principle ≤5 cm; for lesions close to 5 cm, near the cardia/pylorus or expected to cause stenosis or significant gastric deformation after local resection, they are listed as key review cases before surgery, and gastric preservation path can be directly abandoned during surgery;
  5. ECOG performance status score 0-1, able to tolerate general anaesthesia and laparoscopic surgery;
  6. Patient fully understands the potential benefits and uncertainties of SNNS/LECS, the possible false-negative risk of ICG single tracing and intraoperative pathology, as well as the possibility of conversion/additional standard radical gastrectomy, and has signed the informed consent form.

Exclusion Criteria:

  1. Preoperative imaging, endoscopy or MDT suggests cT2 or above, definite lymph node metastasis or distant metastasis;
  2. Pregnant or breastfeeding women;
  3. Previous major upper abdominal surgery leading to expected severe adhesions, significantly affecting SLB localisation or surgical implementation;
  4. Recurrent gastric cancer, multiple primary gastric cancers, or those who received preoperative radiotherapy and chemotherapy;
  5. Cases that have undergone ESD removal and achieved curative resection according to eCura standards;
  6. History of severe ICG allergy or deemed unsuitable by the researcher to use ICG;
  7. Patients with other untreated malignant tumours, severe cardiopulmonary dysfunction, or other conditions unable to tolerate general anaesthesia and pneumoperitoneum;
  8. Those unable to understand the study process or complete standard follow-up.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Perform a combined surgery using both microscopes
  1. Inject the fluorescent dye under the endoscope to mark the lesion.
  2. Remove the sentinel lymph node area highlighted by fluorescence after 15 minutes.
  3. If no lymph node metastasis is found in the sentinel lymph node area (SLNB negative), perform a combined double-scope local gastrectomy (endoscopic combined with laparoscopic local gastrectomy or a modified procedure), completely remove the primary lesion, and ensure negative margins.
  4. The local excision specimen should be fully spread and fixed within 20-30 minutes after removal, and sliced continuously at 2 mm intervals. The pathological report needs to include key information such as tissue type, depth of infiltration, margins and vascular invasion.
  5. Postoperative patients are managed according to the standard postoperative pathway. Follow-ups are done at 1, 3, 6, 12, 24, and 36 months after surgery, and then annually, including physical exams, tumour marker tests, imaging checks, and quality of life questionnaires.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Postoperative complications within 30 days after surgery
Délai: Within 30 days after surgery
Within 30 days after surgery
Overall survival (OS)
Délai: 1 year and 3 years after surgery
1 year and 3 years after surgery
disease-free survival (DFS)
Délai: 1 year and 3 years after surgery
1 year and 3 years after surgery
Local recurrence rate (LR)
Délai: 1 year and 3 years after surgery
1 year and 3 years after surgery

Mesures de résultats secondaires

Mesure des résultats
Délai
Sentinel lymph node prediction accuracy (sensitivity, specificity, etc.)
Délai: Up to two weeks after surgery (confirmed by paraffin pathology)
Up to two weeks after surgery (confirmed by paraffin pathology)
Sentinel lymph node tracing success rate
Délai: At most, no more than 2 hours after receiving the specimen for frozen biopsy (intraoperative sentinel lymph node frozen pathology)
At most, no more than 2 hours after receiving the specimen for frozen biopsy (intraoperative sentinel lymph node frozen pathology)
R0 resection rate
Délai: Up to two weeks after surgery(confirmed by paraffin pathology)
Up to two weeks after surgery(confirmed by paraffin pathology)
EORTC QLQ-C30/STO22 scale scores(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30)
Délai: Before the surgery, and at 3, 6, 12 months after, and 2, 3 years post-surgery
Before the surgery, and at 3, 6, 12 months after, and 2, 3 years post-surgery
Weight and Body Mass Index
Délai: Before the surgery, and then 1, 3, 6, 12 months and 2, 3 years after
Before the surgery, and then 1, 3, 6, 12 months and 2, 3 years after
Albumin and haemoglobin(g/L)
Délai: Before the surgery, and then 1, 3, 6, 12 months and 2, 3 years after
Before the surgery, and then 1, 3, 6, 12 months and 2, 3 years after
NRS2002 Nutrition Risk Screening
Délai: Before the surgery, and then 1, 3, 6, 12 months and 2, 3 years after
Before the surgery, and then 1, 3, 6, 12 months and 2, 3 years after

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

8 janvier 2026

Achèvement primaire (Estimé)

1 janvier 2028

Achèvement de l'étude (Estimé)

1 janvier 2028

Dates d'inscription aux études

Première soumission

28 juin 2026

Première soumission répondant aux critères de contrôle qualité

13 juillet 2026

Première publication (Réel)

16 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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