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

Phase 2

• Conditions: Esophageal Cancer; Esophagectomy

• Registration Number: NCT01144325
• Lead Sponsor: Fudan University

Brief 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

Detailed 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 Timeline

• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-06-14
• Study First Posted: 2010-06-15
• Study Start: 2010-07
• Status Verified: 2011-02
• Last Update Submitted: 2011-03-07
• Last Update Posted: 2011-03-08
• Primary Completion: 2013-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Perioperative morbidity and mortality from the two groups	1 -5 years after surgery

Secondary Outcome Measures

Name	Time	Method
short-term quality of life(postoperative 6 months and 1 year) between the two groups	1 year
3-and 5-year survival rate between the two groups	1 - 5 years after surgery

Trial Locations

Locations (1)

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