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

Study Overview
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Brief Summary
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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.

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

Conditions
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Proximal Gastric Adenocarcinoma, Gastric Cancer, Gastroesophageal Reflux Disease

Intervention / Treatment
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* Procedure: Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty (GAP)<br>The reconstruction including esophagogastric anastomosis and pyloroplasty for patients who underwent proximal gastrectomy . The anastomosis locate in the anterior of gastric stump. | Procedure: Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty<br>* The location of the anastomosis in the anterior of the gastric stump. Pyloroplasty is added in the procedure<br>|
| Active Comparator: Control<br>The reconstruction including esophagogastric anastomosis and pyloroplasty for patients who underwent proximal gastrectomy . The anastomosis locate in the posterior or side of gastric stump. | Procedure: Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty<br>* The location of the anastomosis in the anterior of the gastric stump. Pyloroplasty is added in the procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastroesophagus reflux disease apprised by ph monitoring | Ph monitoring by wireless or wire device | 6 months | 
| Gastroesophagus reflux disease apprised by questionnaire | PGSAS-45 questionnaire is adopted. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications of proximal gastrectomy for gastric cancer | Surgical complications include anastomotic leakage, anastomotic stricture, postoperative bleeding, pleural effusion, et al. | 1 year | 
| Long-term outcome | Total survival time after proximal gastrectomy for gastric cancer | 5 years |