Impact on Quality of Life in Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction (GCQOL01)

This study is currently recruiting participants.
Verified September 2012 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Yanong Wang, Fudan University
ClinicalTrials.gov Identifier:
NCT01697917
First received: September 29, 2012
Last updated: October 1, 2012
Last verified: September 2012

September 29, 2012
October 1, 2012
May 2012
May 2015   (final data collection date for primary outcome measure)
Change in QOL (Quality of Life) [ Time Frame: 5years ] [ Designated as safety issue: No ]
From preoperative following gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires.
Same as current
Complete list of historical versions of study NCT01697917 on ClinicalTrials.gov Archive Site
Nutritional status of patients [ Time Frame: 5 years ]
Same as current
Not Provided
Not Provided
 
Impact on Quality of Life in Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Adenocarcinoma of Esophagogastric Junction.
Other: Total Gastrectomy or Proximal Gastrectomy
Total Gastrectomy or Proximal Gastrectomy
Intervention: Other: Total Gastrectomy or Proximal Gastrectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
May 2017
May 2015   (final data collection date for primary outcome measure)

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.
Both
20 Years to 75 Years
No
Contact: Wang Ya Nong, MD, PhD +86-21 64175590 ext 1208 huahuang@fudan.edu.cn
Contact: Huang Hua, MD,PhD +86-21 64175590 ext 1205 huahuang@fudan.edu.cn
China
 
NCT01697917
2012-44-562
No
Yanong Wang, Fudan University
Fudan University
Not Provided
Not Provided
Fudan University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP