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

Esophageal Cancer Clinical Trial

Official title: Minimally Invasive Esophagectomy in Prone or Left Decubitus Position: A Prospective Randomized Clinical Trial From A Single Institution

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Esophagectomy

• NCT number: NCT01144325
• Study type: Interventional
• Source: Fudan University
• Contact: Lijie Tan, MD
• Phone: 86-21-64041990
• Email: tan.lijie@zs-hospital.sh.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: July 2010
• Completion date: December 2016