- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01349517
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
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 Contact
- Name: Tan Lijie, MD
- Phone Number: 2914 86-021-64041990
- Email: tan.lijie@zs-hospital.sh.cn
Study Contact Backup
- Name: Wang Hao, MM
- Phone Number: 2914 86-021-64041990
- Email: wang.hao@zs-hospital.sh.cn
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Zhong Shan Hospital, Fu Dan University
-
Contact:
- Lijie Tan, MD
- Phone Number: 2914 86-021-64041990
- Email: tan.lijie@zs-hospital.sh.cn
-
-
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)
|
The patients in this group would perform minimal invasive three-incision subtotal esophagectomy (thoracoscopic and/or laparoscopic)
Other Names:
|
Other: Three-incision esophagectomy group
The patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy)
|
The patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy)
Other Names:
|
Other: Ivor-Lewis esophagectomy group
The patients in this group would underwent Ivor-Lewis esophagectomy
|
The patients in this group would underwent Ivor-Lewis esophagectomy
Other Names:
|
Other: Sweet esophagectomy group
The patients in this group would underwent Sweet esophagectomy.
|
The patients in this group would underwent Sweet esophagectomy.
Other Names:
|
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
|
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
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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