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Recruiting Not applicable

Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy

NCT06464978 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2024-05-30
Last updated
2026-03-31

Condition(s) studied

Gastric CancerGastrostomyAnastomotic LeakagePostoperative Complications

Investigational drug(s) / intervention(s)

Stapler Reinforcement PatchStandard Stapler

Stapler Reinforcement Patch: Participants in this group will receive gastrojejunostomy with the use of stapler reinforcement patches.

Standard Stapler: Participants in this group will receive gastrojejunostomy with the use of Standard Stapler

Study summary

This is a multi-center, prospective, randomized controlled study aimed at compareing the impact of stapler reinforcement patches versus standard staplers on postoperative complications in gastrojejunostomy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Rate of Anastomotic Leakage — 30 days post-surgery
    The incidence of anastomotic leakage within 30 days post-surgery. Anastomotic leakage is defined as the presence of fluid containing enteric content in the abdominal cavity or the appearance of leakage confirmed by imaging or endoscopy.

Trial sites (1)

FacilityCityRegionStatus
Yunhong Tian Nanchong Sichuan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06464978 on ClinicalTrials.gov ↗ ← All trials in China