Single-port Versus Conventional Laparoscopic Surgery for Radical Proximal Gastric Cancer: A Randomized Controlled Trial

Официальное название

A Prospective, Single-center, Randomized Control Led Study of Laparoscopic Single-port Surgery System Versus Traditional Laparoscopic Surgery in Radical Proximal Gastric Cancer

Обзор

To evaluate the safety and efficacy of SP1000 and conventional laparoscopy in radical gastrectomy for proximal gastric cancer.

Вмешательства

• Устройство Single-Port Robotic Surgical System
  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.
• Процедура Traditional Laparoscopic Surgery
  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.

Первичные конечные точки

• Incidence of Total Postoperative Complications (Clavien-Dindo Grade ≥ II) [Срок оценки: Within 30 days postoperatively.]

Вторичные конечные точки (4)

• Estimated Blood Loss [Срок оценки: During the surgical procedure (Day 0).]
• Time to First Flatus [Срок оценки: Up to 30 days postoperatively.]
• Total Operation Time [Срок оценки: During the surgical procedure (Day 0).]
• Conversion Rate [Срок оценки: During the surgical procedure (Day 0).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou

Идентификаторы

NCT: NCT07586384 · KY2025-143 · ChiCTR2500109905

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)
• ChiCTR ChiCTR2500109905 (Китайский реестр КИ)

Открыть это исследование на ClinicalTrials.gov ↗