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

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Esophageal Cancer

Treatments: Procedure: Sweet esophagectomy; Procedure: MIE; Procedure: Three-incision thoracotomy; Procedure: Ivor-Lewis esophagectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01349517

ZSchest2011001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 4 patient groups

MIE Group

Other group

Description:

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

Treatment:

Procedure: MIE

Three-incision esophagectomy group

Other group

Description:

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

Treatment:

Procedure: Three-incision thoracotomy

Ivor-Lewis esophagectomy group

Other group

Description:

The patients in this group would underwent Ivor-Lewis esophagectomy

Treatment:

Procedure: Ivor-Lewis esophagectomy

Sweet esophagectomy group

Other group

Description:

The patients in this group would underwent Sweet esophagectomy.

Treatment:

Procedure: Sweet esophagectomy