Single-port robotic vs traditional laparoscopic surgery for proximal stomach cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares single-port robotic surgery using the SP1000 system with conventional laparoscopic surgery for radical proximal gastrectomy in patients with proximal gastric cancer. Eligible adults undergo preoperative assessment and are assigned to one of the two surgical methods, with perioperative safety and short- and long-term outcomes recorded. The study focuses on feasibility of R0 resection, functional reconstruction, and postoperative recovery, evaluating safety and efficacy over a 12-month follow-up. Surgical teams and pathologists will follow standardized protocols to minimize variability. Primary endpoints likely include safety and oncologic adequacy, with secondary endpoints addressing recovery, complications, and functional outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Wenzhou Medical University
  Wenzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Xian Shen
• Email: shenxian1120@126.com
• Phone: +86 139 6888 8872

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.