Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06464978
• Other study ID #: 20240530
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2024
• Est. completion date: June 2026

Study information

• Verified date: June 2024
• Source: Nanchong Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 382
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anastomotic Leak
• Anastomotic Leakage
• Gastric Cancer
• Gastrostomy
• Postoperative Complications

Intervention

Device:
• Stapler Reinforcement Patch
Participants in this group will receive gastrojejunostomy with the use of stapler reinforcement patches.
• Standard Stapler
Participants in this group will receive gastrojejunostomy with the use of Standard Stapler

Locations

Country	Name	City	State
China	Yunhong Tian	Nanchong	Sichuan

Sponsors (6)

Lead Sponsor	Collaborator
Nanchong Central Hospital	Guang'an Central Hospital, Langzhong People's Hospital, Nanbu Hospital of County Chinese Medicine, Pengan County People's Hospital, Yilong County people's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of Anastomotic Stricture	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
Secondary	Postoperative Bleeding Rate	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
Secondary	Mortality Rate	The rate of mortality within 30 days post-surgery.	30 days post-surgery
Secondary	Readmission Rate	Readmission Rate	3 months post-surgery