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

This study is not yet open for participant recruitment.
Verified January 2011 by Fudan University
Sponsor:
Collaborators:
First Hospital of Jilin University
Fujian Medical University
Shanxi Cancer Hospital
Wujin People's Hospital，Jiangsu University
Linyi People's Hospital, Shangdong University
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01349517
First received: May 3, 2011
Last updated: November 10, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
 Procedure: MIE
Procedure: Three-incision thoracotomy
Procedure: Ivor-Lewis esophagectomy
Procedure: Sweet esophagectomy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Health-related Quality of Life of Patients With Esophageal Cancer After Surgery in China: A Prospective Cohort Study From Multi-center

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Health related quality of life [ Time Frame: postoperative 2 year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    • Perioperative morbidity and mortality from the different precedure groups.
    • 3-and 5-year survival rate between the groups.


Estimated Enrollment: 400
Study Start Date: May 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: esophagectomy
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 Name: esophagectomy
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 Name: esophagectomy
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 Name: esophagectomy

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.
  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349517

Contacts
Contact: Tan Lijie, MD 86-021-64041990 ext 2914 tan.lijie@zs-hospital.sh.cn
Contact: Wang Hao, MM 86-021-64041990 ext 2914 wang.hao@zs-hospital.sh.cn

Locations
China, Shanghai
Zhong Shan Hospital, Fu Dan University Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Lijie Tan, MD     86-021-64041990 ext 2914     tan.lijie@zs-hospital.sh.cn    
Sponsors and Collaborators
Fudan University
First Hospital of Jilin University
Fujian Medical University
Shanxi Cancer Hospital
Wujin People's Hospital，Jiangsu University
Linyi People's Hospital, Shangdong University
Investigators
Study Chair: Lijie Tan, MD Zhongshan Hospital, Fudan University, China
  More Information

No publications provided

Responsible Party: Tan Lijie MD, Associate Professor of Surgery, Zhong Shan Hospital, Fu Dan University, Shanghai, China,
ClinicalTrials.gov Identifier: NCT01349517     History of Changes
Other Study ID Numbers: ZSchest2011001
Study First Received: May 3, 2011
Last Updated: November 10, 2011
Health Authority: China: Ministry of Health

Keywords provided by Fudan University:
health-related quality of life(HRQL)
Esophageal Cancer

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013