Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy

NCT06464978 | Recruiting

• 1 other identifier: 20240530
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications; Gastric Cancer; Gastrostomy; Anastomotic Leakage

Keywords

Stapler Reinforcement Patch; Gastrojejunostomy; Randomized Controlled Trial; Surgical Outcomes; Complication Prevention

Outcome Measures

Primary Outcomes (1)

• Rate of Anastomotic Leakage

  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 Outcomes (4)

• Rate of Anastomotic Stricture

  3 months post-surgery

• Postoperative Bleeding Rate

  30 days post-surgery

• Mortality Rate

  30 days post-surgery

• Readmission Rate

  3 months post-surgery

Study Arms (2)

Stapler Reinforcement Patch Group

EXPERIMENTAL

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

Device: Stapler Reinforcement Patch

Standard Stapler Group

ACTIVE COMPARATOR

Participants in this group will receive gastrojejunostomy with the use of standard staplers.

Device: Standard Stapler

Interventions

Stapler Reinforcement Patch DEVICE

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

Stapler Reinforcement Patch Group

Standard Stapler DEVICE

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

Standard Stapler Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Yunhong Tian

Nanchong, Sichuan, 637000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Anastomotic Leak; Postoperative Complications

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcomes assessors will be blinded to the group assignments. Surgeons will be aware of the group assignments but will not disclose this information to the participants or the outcomes assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to either the experimental group receiving the stapler reinforcement patches or the control group undergoing standard procedures without reinforcement patches.

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 18, 2024
• Study Start: May 30, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

CN (1)