Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy

Not Applicable

Recruiting

• Conditions: Anastomotic Leakage; Postoperative Complications; Gastric Cancer; Gastrostomy
• Interventions: Device: Stapler Reinforcement Patch; Device: Standard Stapler

• Registration Number: NCT06464978
• Lead Sponsor: Nanchong Central Hospital

Brief 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.

Detailed Description

This study compares stapler reinforcement patches with standard staplers in gastrojejunostomy to reduce postoperative complications. It aims to demonstrate the effectiveness and safety of these patches in preventing anastomotic leakage and other related complications.

Study Timeline

• Study Start: 2024-05-30
• Status Verified: 2024-06
• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-13
• Last Update Submitted: 2024-06-13
• Study First Posted: 2024-06-18
• Last Update Posted: 2024-06-18
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 382

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stapler Reinforcement Patch Group	Stapler Reinforcement Patch	Participants in this group will receive gastrojejunostomy with the use of stapler reinforcement patches.
Standard Stapler Group	Standard Stapler	Participants in this group will receive gastrojejunostomy with the use of standard staplers.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Rate of Anastomotic Stricture	3 months post-surgery	The incidence of anastomotic stricture within 3 months post-surgery. Anastomotic stricture is defined as difficulty in food passage or narrowing confirmed by imaging or endoscopy.
Postoperative Bleeding Rate	30 days post-surgery	The incidence of postoperative bleeding within 30 days post-surgery. Postoperative bleeding is defined as the occurrence of bleeding requiring intervention or causing significant hemoglobin drop.
Mortality Rate	30 days post-surgery	The rate of mortality within 30 days post-surgery.
Readmission Rate	3 months post-surgery	Readmission Rate

Trial Locations

Locations (1)

Yunhong Tian; 🇨🇳 Nanchong, Sichuan, China