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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Fudan University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01349517
First Posted: May 6, 2011
Last Update Posted: November 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
First Hospital of Jilin University
Fujian Medical University Union Hospital
Shanxi Province Cancer Hospital
Wuxi People's Hospital
Linyi People's Hospital
Information provided by:
Fudan University
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Union Hospital
Shanxi Province Cancer Hospital
Wuxi People's Hospital
Linyi People's Hospital
Investigators
Study Chair: Lijie Tan, MD Zhongshan Hospital, Fudan University, China
  More Information

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
First Submitted: May 3, 2011
First Posted: May 6, 2011
Last Update Posted: November 11, 2011
Last Verified: January 2011

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

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