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

Phase 2

• Conditions: Esophageal Cancer
• Interventions: Procedure: MIE; Procedure: Three-incision thoracotomy; Procedure: Ivor-Lewis esophagectomy; Procedure: Sweet esophagectomy

• Registration Number: NCT01349517
• Lead Sponsor: Fudan University

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.

Study Timeline

• Status Verified: 2011-01
• Study Start: 2011-05
• Study First Submitted: 2011-05-03
• Study First Submitted QC: 2011-05-05
• Study First Posted: 2011-05-06
• Last Update Submitted: 2011-11-10
• Last Update Posted: 2011-11-11
• Primary Completion: 2013-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Health related quality of life	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

Name	Time	Method
Morbidity Mortality Survival rate	5 years	* Perioperative morbidity and mortality from the different precedure groups.; * 3-and 5-year survival rate between the groups.

Trial Locations

Locations (1)

Zhong Shan Hospital, Fu Dan University; 🇨🇳 Shanghai, Shanghai, China