Back to resultsHealth-related Quality of Life of Patients With Esophageal Cancer After Surgery
Primary Purpose
Esophageal Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
MIE
Three-incision thoracotomy
Ivor-Lewis esophagectomy
Sweet esophagectomy
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring health-related quality of life(HRQL), Esophageal Cancer
Eligibility Criteria
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
Sites / Locations
- Zhong Shan Hospital, Fu Dan University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
MIE Group
Three-incision esophagectomy group
Ivor-Lewis esophagectomy group
Sweet esophagectomy group
Arm Description
The patients in this group would perform minimal invasive three-incision subtotal esophagectomy (thoracoscopic and/or laparoscopic)
The patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy)
The patients in this group would underwent Ivor-Lewis esophagectomy
The patients in this group would underwent Sweet esophagectomy.
Outcomes
Primary Outcome Measures
Health related quality of life
Health related quality of life from the different precedure groups (assessed by EORTC QLQ C-30 and OES-18)
Secondary Outcome Measures
Morbidity Mortality Survival rate
Perioperative morbidity and mortality from the different precedure groups.
3-and 5-year survival rate between the groups.
Full Information
NCT ID
NCT01349517
First Posted
May 3, 2011
Last Updated
November 10, 2011
Sponsor
Fudan University
Collaborators
The First Hospital of Jilin University, Fujian Medical University Union Hospital, Shanxi Province Cancer Hospital, Wuxi People's Hospital, Linyi People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01349517
Brief Title
Health-related Quality of Life of Patients With Esophageal Cancer After Surgery
Official Title
Health-related Quality of Life of Patients With Esophageal Cancer After Surgery in China: A Prospective Cohort Study From Multi-center
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Fudan University
Collaborators
The First Hospital of Jilin University, Fujian Medical University Union Hospital, Shanxi Province Cancer Hospital, Wuxi People's Hospital, Linyi People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
health-related quality of life(HRQL), Esophageal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MIE Group
Arm Type
Other
Arm Description
The patients in this group would perform minimal invasive three-incision subtotal esophagectomy (thoracoscopic and/or laparoscopic)
Arm Title
Three-incision esophagectomy group
Arm Type
Other
Arm Description
The patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy)
Arm Title
Ivor-Lewis esophagectomy group
Arm Type
Other
Arm Description
The patients in this group would underwent Ivor-Lewis esophagectomy
Arm Title
Sweet esophagectomy group
Arm Type
Other
Arm Description
The patients in this group would underwent Sweet esophagectomy.
Intervention Type
Procedure
Intervention Name(s)
MIE
Other Intervention Name(s)
esophagectomy
Intervention Description
The patients in this group would perform minimal invasive three-incision subtotal esophagectomy (thoracoscopic and/or laparoscopic)
Intervention Type
Procedure
Intervention Name(s)
Three-incision thoracotomy
Other Intervention Name(s)
esophagectomy
Intervention Description
The patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy)
Intervention Type
Procedure
Intervention Name(s)
Ivor-Lewis esophagectomy
Other Intervention Name(s)
esophagectomy
Intervention Description
The patients in this group would underwent Ivor-Lewis esophagectomy
Intervention Type
Procedure
Intervention Name(s)
Sweet esophagectomy
Other Intervention Name(s)
esophagectomy
Intervention Description
The patients in this group would underwent Sweet esophagectomy.
Primary Outcome Measure Information:
Title
Health related quality of life
Description
Health related quality of life from the different precedure groups (assessed by EORTC QLQ C-30 and OES-18)
Time Frame
postoperative 2 year
Secondary Outcome Measure Information:
Title
Morbidity Mortality Survival rate
Description
Perioperative morbidity and mortality from the different precedure groups.
3-and 5-year survival rate between the groups.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tan Lijie, MD
Phone
86-021-64041990
Ext
2914
Email
tan.lijie@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Hao, MM
Phone
86-021-64041990
Ext
2914
Email
wang.hao@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lijie Tan, MD
Organizational Affiliation
Zhongshan Hospital, Fudan University, China
Official's Role
Study Chair
Facility Information:
Facility Name
Zhong Shan Hospital, Fu Dan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijie Tan, MD
Phone
86-021-64041990
Ext
2914
Email
tan.lijie@zs-hospital.sh.cn
12. IPD Sharing Statement
Learn more about this trial
Health-related Quality of Life of Patients With Esophageal Cancer After Surgery
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