Minimally Invasive Esophagectomy (MIE) in Prone Versus Left Decubitus Position

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Esophageal Cancer; Esophagectomy

Treatments: Procedure: thoracoscopic esophagectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01144325

ZSchest2010001

MIEFUDANU2010001 (Other Identifier)

Details and patient eligibility

About

The purpose of this prospective randomized study is to compare clinical outcomes from two different patient position(prone vs left decubitus)with thoracoscopic esophageal mobilization in the procedure of Minimally Invasive Esophagectomy (MIE).

• Comparing morbidities from the two groups
• Comparing short-term quality of life from the two groups
• Comparing oncological results (3,5 year survival) from the two groups

Full description

Thoracoscopic esophagectomy is routinely performed in two positions. The left decubitus position is the most commonly used position at most centers. However prone position is another alternative.

The left decubitus position is advocated for its the same position as the open procedure and easy to learn, as well as easy to emergent conversion to open thoracotomy .However, the disadvantage of this position is the need of lung retraction for better exposure and definitely one lung ventilation. They are regarded as potential causes leading lung injury.

Prone thoracoscopic esophageal mobilization has been advocated for its potential benefits of increased operative exposure, no lung retraction, avoid one lung ventilation, improved surgeon ergonomics. But it is difficult to make emergent conversion under this positon and not familiar with most thoracic or digestive surgeons. A longer learning curve may be needed.

A few publications have compared the two position with thoracoscopic mobilization of the esophagus in retrospective study of a small cohort. Until now, no prospective randomized study has been carried out in this field.

Enrollment: 2 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
• sign informed consent

Exclusion criteria

• Patients who received neoadjuvant therapy
• Mental disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind