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NCT Number: NCT06464978

Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy

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.

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Key information

Conditions

Gastric Cancer Anastomotic Leak Anastomotic Leakage Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrostomy Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Stomach Diseases Stomach Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yunhong Tian

Nanchong, Sichuan, 637000, China

Location status: Recruiting

Location contact

Yunhong Tian, PHD

CONTACT

[email protected]

13508087719

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stapler Reinforcement Patch

Device

Participants in this group will receive gastrojejunostomy with the use of stapler reinforcement patches.

Standard Stapler

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Mortality Rate

    Time frame: 30 days post-surgery

    The rate of mortality within 30 days post-surgery.

  4. Readmission Rate

    Time frame: 3 months post-surgery

    Readmission Rate

Sponsors and collaborators

Lead sponsor

Nanchong Central Hospital

Other Gov

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jun 18, 2024
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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