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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


Phase 3
20 Years
75 Years
Open (Enrolling)
Both
Adenocarcinoma of Esophagogastric Junction.

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in QOL (Quality of Life)

Outcome Description:

From preoperative following gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires.

Outcome Time Frame:

5years

Safety Issue:

No

Authority:

China: Food and Drug Administration

Study ID:

2012-44-562

NCT ID:

NCT01697917

Start Date:

May 2012

Completion Date:

May 2017

Related Keywords:

  • Adenocarcinoma of Esophagogastric Junction.
  • Adenocarcinoma of Esophagogastric Junction
  • Total Gastrectomy
  • Proximal Gastrectomy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous

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