NCT07586384 Single-port Versus Conventional Laparoscopic Surgery for Radical Proximal Gastric Cancer: A Randomized Controlled Trial
| NCT ID | NCT07586384 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Wenzhou Medical University |
| Condition | Stomach Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-11-05 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-11-05 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the safety and efficacy of SP1000 and conventional laparoscopy in radical gastrectomy for proximal gastric cancer.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07586384 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Stomach Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07586384 currently recruiting?
Yes, NCT07586384 is actively recruiting participants. Contact the research team at shenxian1120@126.com for enrollment information.
Where is the NCT07586384 trial being conducted?
This trial is being conducted at Wenzhou, China.
Who is sponsoring the NCT07586384 clinical trial?
NCT07586384 is sponsored by First Affiliated Hospital of Wenzhou Medical University. The trial plans to enroll 90 participants.