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NCT07586384Recruiting

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

Source: ClinicalTrials.gov · Last updated 14 May 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
90 (estimated)
First submitted
8 May 2026
Start date
5 Nov 2025
Primary completion date
30 Sept 2027
Lead sponsor
First Affiliated Hospital of Wenzhou Medical University
NCT number
NCT07586384

What you commit to

  • Study type: Interventional
  • Planned participants: 90
  • From 5 Nov 2025 to the primary completion date, 30 Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Wenzhou Medical University
Coordinator of this site? Confirm its status
WenzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.