Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy

Last updated: June 13, 2024
Sponsor: Nanchong Central Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastric Cancer

Treatment

Stapler Reinforcement Patch

Standard Stapler

Clinical Study ID

NCT06464978
20240530
  • Ages 18-85
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Age between 18 and 85 years.

  • Pathologically diagnosed with gastric cancer and suitable for distal gastrectomy orsubtotal 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 legalrepresentative.

Exclusion

Exclusion Criteria:

  • Evidence of potential distant metastasis found preoperatively.

  • History of other malignancies diagnosed within the past 5 years, or any malignancytreated with chemotherapy or radiotherapy.

  • Significant contraindications for surgery (e.g., severe liver or kidneydysfunction).

  • Participation in any other clinical trial within the last 6 months.

  • Participants or their legal representatives unwilling to sign the informed consentor comply with the study protocol.

Study Design

Total Participants: 382
Treatment Group(s): 2
Primary Treatment: Stapler Reinforcement Patch
Phase:
Study Start date:
May 30, 2024
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Yunhong Tian

    Nanchong, Sichuan 637000
    China

    Active - Recruiting

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