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

NCT ID: NCT01349517

Last Updated: 2011-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2016-12-31

Brief Summary

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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

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* 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.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MIE Group

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

Group Type OTHER

MIE

Intervention Type PROCEDURE

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

Three-incision esophagectomy group

The patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy)

Group Type OTHER

Three-incision thoracotomy

Intervention Type PROCEDURE

The patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy)

Ivor-Lewis esophagectomy group

The patients in this group would underwent Ivor-Lewis esophagectomy

Group Type OTHER

Ivor-Lewis esophagectomy

Intervention Type PROCEDURE

The patients in this group would underwent Ivor-Lewis esophagectomy

Sweet esophagectomy group

The patients in this group would underwent Sweet esophagectomy.

Group Type OTHER

Sweet esophagectomy

Intervention Type PROCEDURE

The patients in this group would underwent Sweet esophagectomy.

Interventions

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MIE

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

Intervention Type PROCEDURE

Three-incision thoracotomy

The patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy)

Intervention Type PROCEDURE

Ivor-Lewis esophagectomy

The patients in this group would underwent Ivor-Lewis esophagectomy

Intervention Type PROCEDURE

Sweet esophagectomy

The patients in this group would underwent Sweet esophagectomy.

Intervention Type PROCEDURE

Other Intervention Names

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esophagectomy esophagectomy esophagectomy esophagectomy

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Hospital of Jilin University

OTHER

Sponsor Role collaborator

Fujian Medical University Union Hospital

OTHER

Sponsor Role collaborator

Shanxi Province Cancer Hospital

OTHER

Sponsor Role collaborator

Wuxi People's Hospital

OTHER

Sponsor Role collaborator

Linyi People's Hospital

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Zhong Shan Hospital, Fu Dan University, Shanghai, China,

Principal Investigators

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Lijie Tan, MD

Role: STUDY_CHAIR

Zhongshan Hospital, Fudan University, China

Locations

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Zhong Shan Hospital, Fu Dan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Tan Lijie, MD

Role: CONTACT

86-021-64041990 ext. 2914

Wang Hao, MM

Role: CONTACT

86-021-64041990 ext. 2914

Facility Contacts

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Lijie Tan, MD

Role: primary

86-021-64041990 ext. 2914

Other Identifiers

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ZSchest2011001

Identifier Type: -

Identifier Source: org_study_id