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

13 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Shandong
      • Qingdao, Shandong, Porcelana, 266000
        • Qingdao University Affiliated Hospital West Coast Campus

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Age 18-80, any gender;
  2. Gastric adenocarcinoma confirmed by gastroscopic biopsy, with a single lesion;
  3. Clinical staging cT1N0M0 based on enhanced CT, endoscopic ultrasound and other imaging evaluations (tumour limited to the mucosa or submucosa with no evidence of lymph node or distant metastasis);
  4. Absolute indications for endoscopic submucosal dissection (ESD), with lesions no larger than 5cm, or cases where endoscopic removal is difficult. Absolute indications for ESD (differentiated carcinoma, mucosal T1a stage, without ulcer ≤2 cm or with ulcer ≤3 cm; undifferentiated carcinoma without ulcer ≤2 cm. Difficult cases for endoscopic removal: negative "lifting sign", laterally spreading tumours and scar ulcers etc.);
  5. Meets eCURA score criteria for non-curative ESD requiring additional surgery;
  6. ECOG performance status 0-1;
  7. Patient fully informed and consents, signing the consent form. Note: For inclusion, meeting either criterion ④ or ⑤ is sufficient.

Exclusion Criteria:

  1. Pregnant or breastfeeding women;
  2. Those with a history of major upper abdominal surgery where severe abdominal adhesions are expected;
  3. Patients with recurrent gastric cancer, multiple primary tumours, or those who have undergone preoperative chemoradiotherapy;
  4. Those meeting ESD indications and having completed curative endoscopic resection according to eCURA standards [12,13];
  5. Patients with other unresectable malignant tumours;
  6. Those with severe heart, lung, liver, or kidney dysfunction who cannot tolerate general anaesthesia and surgery;
  7. Those allergic to indocyanine green (ICG) or nano carbon tracers;
  8. Those with mental illness who cannot cooperate with the study and follow-up.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Postoperative complications within 30 days after surgery
Periodo de tiempo: Within 30 days after surgery
Within 30 days after surgery
Overall survival (OS)
Periodo de tiempo: 1 year and 3 years after surgery
1 year and 3 years after surgery
disease-free survival (DFS)
Periodo de tiempo: 1 year and 3 years after surgery
1 year and 3 years after surgery
Local recurrence rate (LR)
Periodo de tiempo: 1 year and 3 years after surgery
1 year and 3 years after surgery

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Sentinel lymph node prediction accuracy (sensitivity, specificity, etc.)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de enero de 2026

Finalización primaria (Estimado)

1 de enero de 2028

Finalización del estudio (Estimado)

1 de enero de 2028

Fechas de registro del estudio

Enviado por primera vez

28 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

13 de julio de 2026

Publicado por primera vez (Actual)

16 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

13 de julio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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