Actively Recruiting
The Impact of Stapler Reinforcement Patches Compared to Standard Staplers on Postoperative Complications in Gastrojejunostomy: A Multicenter Randomized Controlled Trial
Led by Nanchong Central Hospital · Updated on 2026-03-31
382
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Nanchong Central Hospital
Lead Sponsor
G
Guang'an Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of stapler reinforcement patches versus standard staplers on postoperative complications in patients undergoing gastrojejunostomy. This multicenter, prospective, randomized controlled trial focuses on patients with gastric cancer and aims to assess whether these patches can reduce complications such as anastomotic leakage and other related issues following surgery. Participants will be randomly assigned to one of two groups: one group will receive gastrojejunostomy using stapler reinforcement patches, and the other will receive the procedure using standard staplers. The study involves a double-blind design to compare these two surgical devices in order to evaluate their effectiveness and safety in preventing postoperative complications. During the study, researchers will monitor outcomes including the rate of anastomotic leakage within 30 days after surgery, as well as secondary outcomes such as anastomotic stricture rate at 3 months, bleeding, mortality, and readmission rates. Participants will be closely followed for up to three months post-surgery to assess these outcomes and ensure safety, with all necessary assessments and evaluations conducted during this period.
CONDITIONS
Brief Title
Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years
- Pathologically diagnosed with gastric cancer and suitable for distal 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
You will not qualify if you...
- Evidence of potential distant metastasis found preoperatively
- History of other malignancies diagnosed within the past 5 years or treated with chemotherapy or radiotherapy
- Significant contraindications for surgery such as severe liver or kidney dysfunction
- Participation in any other clinical trial within the last 6 months
- Unwillingness to sign informed consent or comply with study protocol by participant or legal representative
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to hospital discharge
Participants undergo gastrojejunostomy surgery using either stapler reinforcement patches or standard staplers, followed by immediate post-operative care.
1 surgical visit and inpatient care
Duration - 3 months
Participants are monitored for postoperative complications, including anastomotic leakage, bleeding, and mortality, with assessments continuing through 3 months post-surgery.
Approximately 4 post-operative visits over 3 months
Trial Site Locations
Total: 1 location
1
Yunhong Tian
Nanchong, Sichuan, China, 637000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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