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

NCT01697917 | Unknown Phase 3

• 1 other identifier: 2012-44-562
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of Esophagogastric Junction.

Keywords

Adenocarcinoma of Esophagogastric Junction; Total Gastrectomy; Proximal Gastrectomy

Outcome Measures

Primary Outcomes (1)

• Change in QOL (Quality of Life)

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

  5years

Secondary Outcomes (1)

• Nutritional status of patients

  5 years

Study Arms (1)

Total Gastrectomy or Proximal Gastrectomy

OTHER

Other: Total Gastrectomy or Proximal Gastrectomy

Interventions

Total Gastrectomy or Proximal Gastrectomy OTHER

Total Gastrectomy or Proximal Gastrectomy

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Central Study Contacts

Wang Ya Nong, MD, PhD

CONTACT

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

Huang Hua, MD,PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Abdominal Surgery

Study Record Dates

• First Submitted: September 29, 2012
• First Posted: October 2, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2017
• Last Updated: October 2, 2012

Record last verified: 2012-09

Locations

CN (1)