Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy

March 29, 2026 updated by: Yunhong Tian, Nanchong Central Hospital

The Impact of Stapler Reinforcement Patches Compared to Standard Staplers on Postoperative Complications in Gastrojejunostomy: A Multicenter Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

382

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Nanchong, Sichuan, China, 637000
        • Recruiting
        • Yunhong Tian
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stapler Reinforcement Patch Group
Participants in this group will receive gastrojejunostomy with the use of stapler reinforcement patches.
Device: Stapler Reinforcement Patch
Participants in this group will receive gastrojejunostomy with the use of stapler reinforcement patches.
Active Comparator: Standard Stapler Group
Participants in this group will receive gastrojejunostomy with the use of standard staplers.
Device: Standard Stapler
Participants in this group will receive gastrojejunostomy with the use of Standard Stapler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Anastomotic Leakage
Time Frame: 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.
30 days post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Anastomotic Stricture
Time Frame: 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.
3 months post-surgery
Postoperative Bleeding Rate
Time Frame: 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.
30 days post-surgery
Mortality Rate
Time Frame: 30 days post-surgery
The rate of mortality within 30 days post-surgery.
30 days post-surgery
Readmission Rate
Time Frame: 3 months post-surgery
Readmission Rate
3 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanchong Central Hospital

Collaborators

Pengan County People's Hospital
Nanbu Hospital of County Chinese Medicine
Langzhong People's Hospital
Guang'an Central Hospital
Yilong County people's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20240530

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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