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NCT05514769 Clinical Trial

Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty Versus Esophagogastric Anastomosis for Gastric Cancer

Gastric Cancer Clinical Trial

Official title:
Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty Versus Esophagogastric Anastomosis for Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05514769
Other study ID # 20220720
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date December 31, 2024

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

Clinical Trial Summary

This research is designed to compare proximal gastrectomy anterior anastomosis with pyloroplasty with esophagogastric anastomosis for gastric cancer. Gastroesophageal reflux disease, postoperative quality of life, short term outcomes, and long term outcomes will be compared.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 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

Procedure:
• Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty
The location of the anastomosis in the anterior of the gastric stump. Pyloroplasty is added in the procedure

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
Primary Gastroesophagus reflux disease apprised by ph monitoring Ph monitoring by wireless or wire device 6 months
Primary Gastroesophagus reflux disease apprised by questionnaire PGSAS-45 questionnaire is adopted. 6 months
Secondary Surgical complications of proximal gastrectomy for gastric cancer Surgical complications include anastomotic leakage, anastomotic stricture, postoperative bleeding, pleural effusion, et al. 1 year
Secondary Long-term outcome Total survival time after proximal gastrectomy for gastric cancer 5 years
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