GCQOL01A Pilot Randomized Controlled Trial Examining the Differences of Quality of Life of Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction
Total Gastrectomy or Proximal Gastrectomy
Treatment Study
Summary
Study start date: May 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.140 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 20 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Fudan University Shanghai Cancer Center
Shanghai, ChinaOpen Fudan University Shanghai Cancer Center in Google Maps