LECS Combined With LSNNS for Early Gastric Cancer (LENS Trial) (LENS)
A Prospective, Single-Arm Study of Laparoscopic and Endoscopic Cooperative Surgery (LECS) Combined With Laparoscopic Sentinel Node Navigation Surgery (LSNNS) for Early Gastric Cancer (LENS Trial)
Early gastric cancer (EGC) is traditionally treated with either endoscopic resection or standard laparoscopic gastrectomy with formal lymph node dissection. However, endoscopic resection cannot evaluate or treat regional lymph node metastasis, whereas standard surgery significantly impairs postoperative gastric physiological function and patient quality of life (QoL). The LENS trial is a prospective, single-arm clinical study designed to evaluate the feasibility, safety, and long-term efficacy of Laparoscopic and Endoscopic Cooperative Surgery (LECS) combined with Laparoscopic Sentinel Node Navigation Surgery (LSNNS) using Indocyanine Green (ICG) fluorescence tracing for patients with cT1N0M0 early gastric cancer. In this trial, eligible patients will undergo intraoperative sentinel lymph node (SN) biopsy guided by ICG. Patients with negative SN status will receive stomach-preserving surgery (primarily Non-exposed Endoscopic Wall-inversion Surgery, NEWS), while those with positive SN status will convert to standard laparoscopic gastrectomy. The primary goal is to confirm whether this combined procedure provides long-term oncological safety comparable to standard radical gastrectomy, while significantly improving postoperative gastric function, nutritional status, and quality of life.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background and Rationale:
Gastric cancer remains a major global health burden, with East Asia bearing the highest incidence. While traditional radical gastrectomy achieves thorough oncological cure through extensive lymphadenectomy, the loss of stomach volume and normal anatomical structure often leads to post-gastrectomy syndromes, malnutrition, and dumping syndrome. Non-exposed Endoscopic Wall-inversion Surgery (NEWS) avoids stomach perforation and tumor seeding, while LSNNS via Indocyanine Green (ICG) mapping accurately identifies first-station drainage lymph nodes to rule out metastasis. Combining NEWS with LSNNS offers a promising minimally invasive strategy that balances oncological safety with optimal organ function preservation. Study Design and Flow:
This is a single-center, prospective, single-arm exploratory study targeting 40 patients with cT1N0M0 early gastric cancer (differentiated T1b > 3 cm or undifferentiated T1b diagnosed by preoperative magnifying endoscopy). Preoperative Baseline Assessment:
Enrolled patients will undergo comprehensive staging and baseline function evaluations, including chest-abdomen-pelvis CT, magnifying endoscopy with biopsy, laboratory nutritional markers (TP, ALB, PA), Electrogastrography (EGG), upper GI contrast study, and quality of life questionnaires (EORTC QLQ-C30 and STO22). Intraoperative Sentinel Node Navigation and Surgery:During surgery, 2 mL (5 mg) of ICG tracer will be injected around the tumor via endoscopic submucosal or laparoscopic subserosal routes. After a 20-minute waiting period, fluorescent sentinel lymph nodes will be navigated and harvested for intraoperative rapid frozen section pathological examination. Intraoperative Decision Path:SN Negative (SBN-): Patients receive stomach-preserving LECS (primarily NEWS) to achieve minimal resection with clear local margins. SN Positive (SBN+): Patients immediately convert to standard laparoscopic gastrectomy with formal D1/D1+ lymph node dissection. Postoperative Management and Rescue Protocol:
If postoperative formal paraffin pathology indicates unexpected lymph node metastasis in patients who underwent LECS, a multidisciplinary team (MDT) discussion will be initiated to decide on completion radical gastrectomy or adjuvant strategies. Follow-up Plan:
Patients will be systematically followed up at 3 months, 1 year, 3 years, and 5 years postoperatively. Evaluation parameters include 3-year and 5-year Disease-Free Survival (DFS), Overall Survival (OS), surgical complications (Clavien-Dindo classification), electrogastrography, nutritional indicators, and QoL scores.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100044
- Reclutamiento
- Peking University People's Hospital
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Contacto:
- Zhidong Gao
- Número de teléfono: 8601088326600
- Correo electrónico: zhouyushi@pku.edu.cn
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
The study population consists of hospitalized patients or outpatient candidates diagnosed with cT1N0M0 early gastric adenocarcinoma at Peking University People's Hospital who are scheduled for laparoscopic surgical treatment and fulfill the study eligibility criteria.
Descripción
Inclusion Criteria:
- Preoperative biopsy confirming solitary lesion of gastric adenocarcinoma
- Preoperative magnifying endoscopy diagnosis of differentiated T1b (> 3 cm) or undifferentiated T1b
- Scheduled to undergo laparoscopic surgery
- Age between 20 and 80 years
- ECOG performance status of 0 or 1
- Signed written informed consent to participate in this clinical study
Exclusion Criteria:
- Suitable for endoscopic treatment (e.g., standard ESD indications)
- Unsuitable for surgery due to severe comorbidities (such as severe cardiopulmonary diseases)
- Pregnant women
- Known history of allergy to Indocyanine Green (ICG)
- Prior history of upper abdominal surgery (except laparoscopic cholecystectomy)
- Prior history of upper abdominal radiation therapy
- Coexistence of other malignant tumors within the past 5 years
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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LECS + LSNNS Group
Eligible early gastric cancer patients will undergo LSNNS with ICG fluorescence tracer. If sentinel lymph nodes are negative by intraoperative frozen pathology, patients receive LECS (e.g., NEWS). If positive, standard laparoscopic gastrectomy with lymphadenectomy will be performed. |
Patients with cT1N0M0 early gastric cancer will undergo Laparoscopic and Endoscopic Cooperative Surgery (LECS) combined with Laparoscopic Sentinel Node Navigation Surgery (LSNNS).Sentinel Lymph Node Biopsy (LSNNS): Indocyanine green will be injected submucosally via endoscopy or subserosally via laparoscopy around the tumor site. After a 20-minute tracer waiting period, fluorescent sentinel lymph nodes (SNs) will be navigated and harvested laparoscopically for intraoperative frozen section pathological evaluation. Surgical Procedure Based on SN Status:If intraoperative SN status is negative (SBN-): Patients will undergo stomach-preserving surgery using non-exposed LECS techniques, primarily Non-exposed Endoscopic Wall-inversion Surgery (NEWS). If intraoperative SN status is positive (SBN+): Patients will immediately convert to standard laparoscopic gastrectomy with formal D1/D1+ lymph node dissection. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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3-Year Disease-Free Survival (DFS)
Periodo de tiempo: 3 years post-operation
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DFS is defined as the proportion of patients who survive without early gastric cancer recurrence (local, regional, or distant) or death from any cause at 3 years after surgery. |
3 years post-operation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Postoperative Complications
Periodo de tiempo: Within 30 days post-operation
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The incidence and severity of postoperative complications will be evaluated and graded according to the Clavien-Dindo classification system (Grade I to Grade V), including bleeding, anastomotic/gastric wall leakage, gastroparesis, wound complications, and intra-abdominal infection. The percentage of participants experiencing at least one complication (Grade II or higher) will be reported. |
Within 30 days post-operation
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Patient-Reported Quality of Life (EORTC QLQ-C30)
Periodo de tiempo: Baseline (pre-operation), 3 months, 1 year, 3 years, and 5 years post-operation.
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Evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores range from 0 to 100, where higher scores for functional scales represent higher/better levels of functioning, and higher scores for symptom scales represent a higher level of symptomatology. |
Baseline (pre-operation), 3 months, 1 year, 3 years, and 5 years post-operation.
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Gastric Cancer-Specific Quality of Life (STO22)
Periodo de tiempo: Baseline (pre-operation), 3 months, 1 year, 3 years, and 5 years post-operation.
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Evaluated using the EORTC QLQ-STO22 module. Scores range from 0 to 100, with higher scores indicating worse gastric-specific symptoms (e.g., dysphagia, pain, reflux, eating restrictions). |
Baseline (pre-operation), 3 months, 1 year, 3 years, and 5 years post-operation.
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5-Year Disease-Free Survival (DFS) and Overall Survival (OS)
Periodo de tiempo: 5 years post-operation
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5-year DFS is defined as the proportion of recurrence-free patients. 5-year OS is defined as the percentage of patients who are still alive at 5 years post-operation regardless of the cause of death. |
5 years post-operation
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Time to First Postoperative Bowel Flatus
Periodo de tiempo: From date of surgery up to postoperative Day 7
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The time interval (in days) from the completion of surgery to the first passage of flatus, serving as a measure of early gastrointestinal functional recovery. |
From date of surgery up to postoperative Day 7
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Change in Body Mass Index (BMI)
Periodo de tiempo: Baseline (pre-operation), at hospital discharge (an average of 7 to 14 days post-operation), 3 months, 1 year, 3 years, and 5 years post-operation.
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Body Mass Index (BMI) will be calculated as weight in kilograms divided by the square of height in meters (kg/m^2). The change from baseline to each post-operative follow-up time point will be evaluated to assess postoperative nutritional status. |
Baseline (pre-operation), at hospital discharge (an average of 7 to 14 days post-operation), 3 months, 1 year, 3 years, and 5 years post-operation.
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Length of Postoperative Hospital Stay
Periodo de tiempo: From date of surgery up to hospital discharge (assessed up to 30 days post-operation)
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The duration from the day of surgery to hospital discharge, measured in days, to evaluate short-term postoperative recovery. |
From date of surgery up to hospital discharge (assessed up to 30 days post-operation)
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Postoperative 30-Day Mortality Rate
Periodo de tiempo: Within 30 days post-operation
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Percentage of participants who die from any cause within 30 days following surgery. |
Within 30 days post-operation
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Enviado por primera vez
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Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LENS-v1.1
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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