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NCT05360069 Clinical Trial

Linear Stapler Versus Circular Stapler in Esophagojejunostomy

Postoperative Complications Clinical Trial

Official title:
Linear Stapler Versus Circular Stapler in Esophagojejunostomy for Patients With Gastric Cancer Underwent Laparoscopic Total Gastrectomy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05360069
Other study ID # 202101
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2025

Study information
Verified date April 2024
Source Nanchong Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

With the development of stapler devices, various methods of esophagojejunostomy after laparoscopic total gastrectomy were evoluated. Which stapler is more advantageous has not been determined. At present, the most commonly used is linear stapler or Circular stapler in esophagojejunostomy. However, there is still a lack of reliable evidence for the selection of the two staplers. The purpose of this study is to explore the advantages of linear staper versus circular stapler in esophagojejunostomy for patients with gastric cancer who underwent total gastrectomy.

Description:

With the development of stapler devices, various methods of esophagojejunostomy after laparoscopic total gastrectomy were evoluated. Which stapler is more advantageous has not been determined. At present, the most commonly used is linear stapler or Circular stapler in esophagojejunostomy. However, there is still a lack of reliable evidence for the selection of the two staplers. The purpose of this study is to explore the advantages of linear staper versus circular stapler in esophagojejunostomy for patients with Siewert classification type II and III gastric cancer who underwent total gastrectomy.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages. 2. Eastern Cooperative Oncology Group performance status of 0 or 1. 3. Adequate organ function. Exclusion Criteria: 1. Patients had distant metastasis. 2. oesophageal invasion of more than 3 cm. 3. Borrmann type 4 or large (more than 8 cm) type 3 carcinoma. 4. Previous chemotherapy or radiation therapy for any other malignancies.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Linear stapler
Linear stapler is adopted in esophagojejunostomy
• Circular stapler
Circular stapler is adopted in esophagojejunostomy

Locations
Country Name City State
China Yunhong Tian Nanchong Sichuan

Sponsors (1)
Lead Sponsor Collaborator
Nanchong Central Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Other hospitalization cost the cost in hospitalization 2 months
Primary Surgical complication All surgical complication after laparoscopic total gastrectomy 6 months
Secondary Operation duration operation time 1 day
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