Back to resultsLinear Stapler Versus Circular Stapler in Esophagojejunostomy
Primary Purpose
Postoperative Complications, Operative Time, Hospital Costs
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Linear stapler
Circular stapler
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Complications focused on measuring laparoscopy, total gastrectomy, esophagojejunostomy, linear stapler, circular stapler
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate organ function.
Exclusion Criteria:
- Patients had distant metastasis.
- oesophageal invasion of more than 3 cm.
- Borrmann type 4 or large (more than 8 cm) type 3 carcinoma.
- Previous chemotherapy or radiation therapy for any other malignancies.
Sites / Locations
- Yunhong TianRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Linear stapler group
Circular stapler group
Arm Description
Linear stapler is adopted in esophagojejunostomy.
Circular stapler is adopted in esophagojejunostomy.
Outcomes
Primary Outcome Measures
Surgical complication
All surgical complication after laparoscopic total gastrectomy
Secondary Outcome Measures
Operation duration
operation time
Full Information
NCT ID
NCT05360069
First Posted
March 11, 2022
Last Updated
June 17, 2023
Sponsor
Nanchong Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05360069
Brief Title
Linear Stapler Versus Circular Stapler in Esophagojejunostomy
Official Title
Linear Stapler Versus Circular Stapler in Esophagojejunostomy for Patients With Gastric Cancer Underwent Laparoscopic Total Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanchong Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Operative Time, Hospital Costs
Keywords
laparoscopy, total gastrectomy, esophagojejunostomy, linear stapler, circular stapler
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Linear stapler group
Arm Type
Experimental
Arm Description
Linear stapler is adopted in esophagojejunostomy.
Arm Title
Circular stapler group
Arm Type
Active Comparator
Arm Description
Circular stapler is adopted in esophagojejunostomy.
Intervention Type
Device
Intervention Name(s)
Linear stapler
Intervention Description
Linear stapler is adopted in esophagojejunostomy
Intervention Type
Device
Intervention Name(s)
Circular stapler
Intervention Description
Circular stapler is adopted in esophagojejunostomy
Primary Outcome Measure Information:
Title
Surgical complication
Description
All surgical complication after laparoscopic total gastrectomy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Operation duration
Description
operation time
Time Frame
1 day
Other Pre-specified Outcome Measures:
Title
hospitalization cost
Description
the cost in hospitalization
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Adequate organ function.
Exclusion Criteria:
Patients had distant metastasis.
oesophageal invasion of more than 3 cm.
Borrmann type 4 or large (more than 8 cm) type 3 carcinoma.
Previous chemotherapy or radiation therapy for any other malignancies.
Facility Information:
Facility Name
Yunhong Tian
City
Nanchong
State/Province
Sichuan
ZIP/Postal Code
637000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunhong Tian, Doctor
Phone
+8613508087719
Email
drtianyunhong@126.com
12. IPD Sharing Statement
Learn more about this trial
Linear Stapler Versus Circular Stapler in Esophagojejunostomy
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