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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 21, 2014