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

Esophageal Cancer Clinical Trial

Official title:

Health-related Quality of Life of Patients With Esophageal Cancer After Surgery in China: A Prospective Cohort Study From Multi-center

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01349517
• Other study ID #: ZSchest2011001
• Status: Not yet recruiting
• Phase: Phase 2
• First received: May 3, 2011
• Last updated: November 10, 2011
• Start date: May 2011
• Est. completion date: December 2016

Study information

• Verified date: January 2011
• Source: Fudan University
• Contact: Tan Lijie, MD
• Phone: 86-021-64041990
• Email: tan.lijie[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 2016
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Procedure:
• MIE
The patients in this group would perform minimal invasive three-incision subtotal esophagectomy (thoracoscopic and/or laparoscopic)
• Three-incision thoracotomy
The patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy)
• Ivor-Lewis esophagectomy
The patients in this group would underwent Ivor-Lewis esophagectomy
• Sweet esophagectomy
The patients in this group would underwent Sweet esophagectomy.

Locations

Country	Name	City	State
China	Zhong Shan Hospital, Fu Dan University	Shanghai	Shanghai

Sponsors (6)

Lead Sponsor	Collaborator
Fudan University	First Hospital of Jilin University, Fujian Medical University, Linyi People's Hospital, Shanxi Province Cancer Hospital, Wuxi People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related quality of life	Health related quality of life from the different precedure groups (assessed by EORTC QLQ C-30 and OES-18)	postoperative 2 year	Yes
Secondary	Morbidity Mortality Survival rate	Perioperative morbidity and mortality from the different precedure groups.; 3-and 5-year survival rate between the groups.	5 years	Yes