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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01697917

Acronym

GCQOL01

Enrollment

140

Registered

2012-10-02

Start date

2012-05-31

Completion date

2017-05-31

Last updated

2012-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma of Esophagogastric Junction.

Keywords

Adenocarcinoma of Esophagogastric Junction, Total Gastrectomy, Proximal Gastrectomy

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.

Interventions

OTHERTotal Gastrectomy or Proximal Gastrectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in QOL (Quality of Life)	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

Measure	Time frame
Nutritional status of patients	5 years

Countries

China

Contacts

Primary ContactWang Ya Nong, MD, PhD

huahuang@fudan.edu.cn+86-21 64175590

Backup ContactHuang Hua, MD,PhD