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NCT Number: NCT07586384

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Single-Port Robotic Surgical System

Device

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.

Traditional Laparoscopic Surgery

Procedure

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.

Primary outcomes

  1. Incidence of Total Postoperative Complications (Clavien-Dindo Grade ≥ II)

    Time frame: Within 30 days postoperatively.

    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.

Secondary outcomes

  1. Estimated Blood Loss

    Time frame: During the surgical procedure (Day 0).

    The amount of blood lost during the surgical procedure, measured in milliliters (mL).

  2. Time to First Flatus

    Time frame: Up to 30 days postoperatively.

    The time from the end of surgery until the participant's first passage of flatus, measured in days.

  3. Total Operation Time

    Time frame: During the surgical procedure (Day 0).

    The duration from the initial skin incision to the completion of skin closure, measured in minutes.

  4. Conversion Rate

    Time frame: During the surgical procedure (Day 0).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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