Comparing stapler reinforcement patches to standard staplers in gastrojejunostomy procedures
Official title: The Impact of Stapler Reinforcement Patches Compared to Standard Staplers on Postoperative Complications in Gastrojejunostomy: A Multicenter Randomized Controlled Trial
Run by Nanchong Central Hospital · NCT06464978 · Data updated 2026-11-12
This study tests if using special patches with staplers during gastric cancer surgery can help prevent complications like leaks compared to regular staplers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 382 (estimated) |
| Sponsor | Nanchong Central Hospital Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nanchong, Sichuan) |
| Status | Recruiting |
| Started | May 30, 2024 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | March 31, 2026 |
| Trial ID | NCT06464978 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 85 with a diagnosis of gastric cancer who are eligible for distal or subtotal gastrectomy.
✕Probably not a fit
Patients with evidence of distant metastasis, significant contraindications for surgery, or those who have participated in other clinical trials recently may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multi-center, prospective, randomized controlled study aims to compare the effectiveness of stapler reinforcement patches against standard staplers in gastrojejunostomy. The focus is on reducing postoperative complications, particularly anastomotic leakage. Participants will be monitored for safety and effectiveness of the patches in preventing complications associated with gastric cancer surgeries. The study involves patients diagnosed with gastric cancer who are suitable for specific surgical procedures.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing gastrojejunostomy.
How similar studies have gone: Other studies have shown promising results with similar approaches, indicating potential for success in this area.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 85 years. * Pathologically diagnosed with gastric cancer and suitable for distal gastrectomy or subtotal gastrectomy. * ECOG performance status of 0 or 1. * ASA (American Society of Anesthesiologists) classification of I-III. * Voluntary signed informed consent from the participant or their legal representative. Exclusion Criteria: * Evidence of potential distant metastasis found preoperatively. * History of other malignancies diagnosed within the past 5 years, or any malignancy treated with chemotherapy or radiotherapy. * Significant contraindications for surgery (e.g., severe liver or kidney dysfunction). * Participation in any other clinical trial within the last 6 months. * Participants or their legal representatives unwilling to sign the informed consent or comply with the study protocol.
Where it's running
-
Yunhong Tian
Nanchong, Sichuan, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.