Health-related Quality of Life of Patients With Esophageal Cancer After Surgery

November 10, 2011 updated by: Fudan University

Health-related Quality of Life of Patients With Esophageal Cancer After Surgery in China: A Prospective Cohort Study From Multi-center

The purpose of this multi-center prospective cohort study is to study the health-related quality of life (HRQL) together with other outcomes of patients with esophageal cancer after surgery in China.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  • To study the influence of health-related quality of life of patients with esophageal cancer before and after surgery.
  • To compare the impact of different procedures on the the health-related quality of life of patients with esophageal cancer.
  • To compare morbidities and oncological results(3,5- year survival) from different procedures.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhong Shan Hospital, Fu Dan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical stage I/II esophageal cancer
  • Normal blood test of basic metabolism panel
  • Pulmonary function: FEV1 > 1.2L, FEV1% > 50%, DLCO > 50%
  • Heart function: NY grade I and grade II

Exclusion Criteria:

  • Mental disorders
  • Combination with other cancers
  • With a previous history of thoracic or ventral surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MIE Group
The patients in this group would perform minimal invasive three-incision subtotal esophagectomy (thoracoscopic and/or laparoscopic)
Procedure: MIE
The patients in this group would perform minimal invasive three-incision subtotal esophagectomy (thoracoscopic and/or laparoscopic)
Other Names:
  • esophagectomy
Other: Three-incision esophagectomy group
The patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy)
Procedure: Three-incision thoracotomy
The patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy)
Other Names:
  • esophagectomy
Other: Ivor-Lewis esophagectomy group
The patients in this group would underwent Ivor-Lewis esophagectomy
Procedure: Ivor-Lewis esophagectomy
The patients in this group would underwent Ivor-Lewis esophagectomy
Other Names:
  • esophagectomy
Other: Sweet esophagectomy group
The patients in this group would underwent Sweet esophagectomy.
Procedure: Sweet esophagectomy
The patients in this group would underwent Sweet esophagectomy.
Other Names:
  • esophagectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life
Time Frame: postoperative 2 year
Health related quality of life from the different precedure groups (assessed by EORTC QLQ C-30 and OES-18)
postoperative 2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity Mortality Survival rate
Time Frame: 5 years
  • Perioperative morbidity and mortality from the different precedure groups.
  • 3-and 5-year survival rate between the groups.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

Shanxi Province Cancer Hospital
The First Hospital of Jilin University
Fujian Medical University Union Hospital
Wuxi People's Hospital
Linyi People's Hospital

Investigators

  • Study Chair: Lijie Tan, MD, Zhongshan Hospital, Fudan University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 3, 2011

First Submitted That Met QC Criteria

May 5, 2011

First Posted (Estimate)

May 6, 2011

Study Record Updates

Last Update Posted (Estimate)

November 11, 2011

Last Update Submitted That Met QC Criteria

November 10, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSchest2011001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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