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

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Fudan University

Status and phase

Unknown
Phase 3

Conditions

Adenocarcinoma of Esophagogastric Junction.

Treatments

Other: Total Gastrectomy or Proximal Gastrectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01697917
2012-44-562

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

140 participants in 1 patient group

Total Gastrectomy or Proximal Gastrectomy
Other group
Treatment:
Other: Total Gastrectomy or Proximal Gastrectomy

Trial contacts and locations

0

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Central trial contact

Huang Hua, MD,PhD; Wang Ya Nong, MD, PhD

Data sourced from clinicaltrials.gov

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