Impact on Quality of Life in Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction

Study Overview
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Brief Summary
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The purpose of this study is to find out more about differences of the quality of life in patients undergoing total gastrectomy or proximal gastrectomy for adenocarcinoma of esophagogastric junction. To find a better reconstruction for patients who received total gastrectomy.

Detailed Description
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Overall, the incidence of stomach cancer worldwide is declining with geographical variation. However, an increase in the incidence rate of adenocarcinoma of esophagogastric junction, called cardia or AEG has been observed in recent years. AEG may represent a specific histopathological and biologic entity. In the treatment AEG there is argument over whether proximal gastractomy(PG) or total gastractomy (TG) should be done. The quality of life (QOL) of the patients following TG or PG arouses people's attention. The purpose of this study was to evaluate differences of the quality of life in patients undergoing total gastrectomy or proximal gastrectomy for adenocarcinoma of esophagogastric junction.

Official Title
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A Pilot Randomized Controlled Trial Examining the Differences of Quality of Life of Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction

Conditions
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Adenocarcinoma of Esophagogastric Junction.

Intervention / Treatment
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* Other: Total Gastrectomy or Proximal Gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Pathologically confirmed gastric malignant tumor at FUSCC (biopsy may be performed at other institutions but slides must be confirmed at FUSCC, as is routine care at our institution), and the patients be assessed can achieve R0 radical dissection through total gastrectomy or proximal gastrectomy by three specialists. Patients 20-75 years old Normal organ function, able to tolerate surgery, no clear contraindication for surgery No evidence of metastases of adjacent organs be able to provide follow-up over 2 years No specific treatment for gastric cancer before surgery In line with the Declaration of Helsinki and the requirements of the hospital ethics committee. The subjects were able to understand and comply with the trial protocol, and signed informed consent. Exclusion Criteria: • AEG SiewertⅠtype patients Synchronous or metachronous (less than five years) and patients with other malignancies. Cirrhosis and portal hypertension Associated with blood diseases Serious heart/ lung and kidney dysfunction or with metabolic diseases such as diabetes, hyperthyroidism. Suffering from a serious neurological disease or psychological diseases affecting the life.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Total Gastrectomy or Proximal Gastrectomy<br> | Other: Total Gastrectomy or Proximal Gastrectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in QOL (Quality of Life) | From preoperative following gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires. | 5years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status of patients |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adenocarcinoma of Esophagogastric Junction, Total Gastrectomy, Proximal Gastrectomy