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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01349517
Enrollment
400
Registered
2011-05-06
Start date
2011-05-31
Completion date
2016-12-31
Last updated
2011-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

health-related quality of life(HRQL), Esophageal Cancer

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.

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.

Interventions

PROCEDUREMIE

The patients in this group would perform minimal invasive three-incision subtotal esophagectomy (thoracoscopic and/or laparoscopic)

PROCEDUREThree-incision thoracotomy

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.

Sponsors

The First Hospital of Jilin University
CollaboratorOTHER
Fujian Medical University Union Hospital
CollaboratorOTHER
Shanxi Province Cancer Hospital
CollaboratorOTHER
Wuxi People's Hospital
CollaboratorOTHER
Linyi People's Hospital
CollaboratorOTHER
Fudan University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Health related quality of lifepostoperative 2 yearHealth related quality of life from the different precedure groups (assessed by EORTC QLQ C-30 and OES-18)

Secondary

MeasureTime frameDescription
Morbidity Mortality Survival rate5 years* Perioperative morbidity and mortality from the different precedure groups. * 3-and 5-year survival rate between the groups.

Countries

China

Contacts

Primary ContactTan Lijie, MD
tan.lijie@zs-hospital.sh.cn86-021-64041990
Backup ContactWang Hao, MM
wang.hao@zs-hospital.sh.cn86-021-64041990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026