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
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Fudan University
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Change in QOL (Quality of Life)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Total Gastrectomy or Proximal Gastrectomy
Intervention: Total Gastrectomy or Proximal Gastrectomy (Other)
Outcomes
Primary Outcomes
Change in QOL (Quality of Life)
Time Frame: 5years
From preoperative following gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires.
Secondary Outcomes
- Nutritional status of patients(5 years)
Investigators
Yanong Wang
Director of Department of Abdominal Surgery
Fudan University