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

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

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

Study Overview

• Status: Unknown
• Conditions: Esophageal Cancer; Esophagectomy
• Intervention / Treatment: Procedure: thoracoscopic esophagectomy

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 Type: Interventional
• Enrollment (Anticipated): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • Zhong Shan Hospital, Fu Dan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Perioperative morbidity and mortality from the two groups	1 -5 years after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: May 26, 2010
• First Submitted That Met QC Criteria: June 14, 2010
• First Posted (Estimate): June 15, 2010

Study Record Updates

• Last Update Posted (Estimate): March 8, 2011
• Last Update Submitted That Met QC Criteria: March 7, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Minimally Invasive Esophagectomy
• Other Study ID Numbers: ZSchest2010001; MIEFUDANU2010001 (Other Identifier: Zhong Shan Hospital, Fu Dan University)