Health-related Quality of Life of Patients With Esophageal Cancer After Surgery
1 other identifier
interventional
400
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2011
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 3, 2011
CompletedFirst Posted
Study publicly available on registry
May 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedNovember 11, 2011
January 1, 2011
2.6 years
May 3, 2011
November 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Morbidity Mortality Survival rate
5 years
Study Arms (4)
MIE Group
OTHERThe patients in this group would perform minimal invasive three-incision subtotal esophagectomy (thoracoscopic and/or laparoscopic)
Three-incision esophagectomy group
OTHERThe patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy)
Ivor-Lewis esophagectomy group
OTHERThe patients in this group would underwent Ivor-Lewis esophagectomy
Sweet esophagectomy group
OTHERThe patients in this group would underwent Sweet esophagectomy.
Interventions
The patients in this group would perform minimal invasive three-incision subtotal esophagectomy (thoracoscopic and/or laparoscopic)
The patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy)
The patients in this group would underwent Ivor-Lewis esophagectomy
The patients in this group would underwent Sweet esophagectomy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Mental disorders
- Combination with other cancers
- With a previous history of thoracic or ventral surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
- The First Hospital of Jilin Universitycollaborator
- Fujian Medical University Union Hospitalcollaborator
- Shanxi Province Cancer Hospitalcollaborator
- Wuxi People's Hospitalcollaborator
- Linyi People's Hospitalcollaborator
Study Sites (1)
Zhong Shan Hospital, Fu Dan University
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lijie Tan, MD
Zhongshan Hospital, Fudan University, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 3, 2011
First Posted
May 6, 2011
Study Start
May 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2016
Last Updated
November 11, 2011
Record last verified: 2011-01