Clinical trial NCT01697917: Impact on Quality of Life in Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Adenocarcinoma of Esophagogastric Junction.
Keywords: Adenocarcinoma of Esophagogastric Junction
Total Gastrectomy
Proximal Gastrectomy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in QOL (Quality of Life)
timeFrame: 5years
Secondary outcomes:
measure: Nutritional status of patients
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: