Single-port Versus Conventional Laparoscopic Surgery for Radical Proximal Gastric Cancer: A Randomized Controlled Trial
A Prospective, Single-center, Randomized Control Led Study of Laparoscopic Single-port Surgery System Versus Traditional Laparoscopic Surgery in Radical Proximal Gastric Cancer
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Xian Shen
- Número de teléfono: +86 139 6888 8872
- Correo electrónico: shenxian1120@126.com
Ubicaciones de estudio
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Zhejiang
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Wenzhou, Zhejiang, Porcelana
- Reclutamiento
- The First Affiliated Hospital of Wenzhou Medical University
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Contacto:
- Xian Shen
- Número de teléfono: +86 139 6888 8872
- Correo electrónico: shenxian1120@126.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age between 18 and 75 years inclusive.
ECOG performance status ≤ 2.
Histologically confirmed proximal gastric cancer or Siewert type II adenocarcinoma of the esophagogastric junction.
Clinical stage cT1-T3, N0-N+, M0.
Tumor maximum diameter ≤ 4 cm and esophageal invasion ≤ 2 cm.
Candidates for radical proximal gastrectomy (PG) with feasibility of R0 resection and functional anastomosis.
Assessed by a Multidisciplinary Team (MDT) as suitable for PG rather than total gastrectomy, with no requirement for neoadjuvant therapy.
Radiographic evidence of localized disease (no distant metastasis to liver, lung, or peritoneum via enhanced CT or MRI).
ASA physical status classification ≤ III.
Adequate bone marrow, hepatic, renal, cardiac, and pulmonary function.
Ability to understand and provide written informed consent.
Willingness and ability to comply with the 12-month postoperative follow-up schedule.
Exclusion Criteria:
- Clinical stage T4 or presence of distant metastasis.
Esophageal invasion exceeding 2 cm.
History of previous major gastric surgery (e.g., partial or total gastrectomy).
Other malignant tumors within the last 5 years.
Severe organic diseases that preclude safe anesthesia or surgery (e.g., severe heart failure, pulmonary fibrosis).
Requirement for emergency surgery due to active gastric bleeding, perforation, or acute obstruction.
Pregnant or lactating women.
Serious psychiatric disorders or cognitive impairment that interferes with study compliance.
Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Single-Port Group
Participants in this group will undergo radical proximal gastrectomy utilizing the SP1000 single-port surgical platform.
The procedure focuses on performing the main surgical maneuvers through a centralized access point to evaluate the safety and clinical performance of the robotic system.
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An investigational robotic-assisted surgical platform designed for single-port access.
In this study, the system is utilized to perform radical proximal gastrectomy.
The core surgical procedures are conducted through a centralized access point to assess the intraoperative safety and short-term clinical outcomes of this robotic-assisted approach.
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Comparador activo: Traditional Laparoscopy Group
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Standard multi-port laparoscopic radical proximal gastrectomy performed as a clinical control.
This procedure follows conventional laparoscopic techniques involving multiple abdominal incisions for the placement of surgical instruments and camera to treat proximal gastric cancer.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Total Postoperative Complications (Clavien-Dindo Grade ≥ II)
Periodo de tiempo: Within 30 days postoperatively.
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The proportion of participants experiencing at least one postoperative complication graded II or higher according to the Clavien-Dindo Classification.
This includes surgery-related, systemic, and anesthesia-related complications.
If a patient experiences multiple complications, only the most severe grade will be used for statistical analysis.
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Within 30 days postoperatively.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Estimated Blood Loss
Periodo de tiempo: During the surgical procedure (Day 0).
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The amount of blood lost during the surgical procedure, measured in milliliters (mL).
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During the surgical procedure (Day 0).
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Time to First Flatus
Periodo de tiempo: Up to 30 days postoperatively.
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The time from the end of surgery until the participant's first passage of flatus, measured in days.
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Up to 30 days postoperatively.
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Total Operation Time
Periodo de tiempo: During the surgical procedure (Day 0).
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The duration from the initial skin incision to the completion of skin closure, measured in minutes.
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During the surgical procedure (Day 0).
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Conversion Rate
Periodo de tiempo: During the surgical procedure (Day 0).
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The proportion of participants in the Single-Port group who require conversion to traditional multi-port laparoscopy or open surgery due to technical or safety factors.
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During the surgical procedure (Day 0).
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KY2025-143
- ChiCTR2500109905 (Otro identificador: Chinese Clinical Trial Registry)
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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