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

• Sponsor: Fudan University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01144325
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Duration (Months): 77
• Patients Per Site Per Month: 0

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer; Esophagectomy	Procedure: thoracoscopic esophagectomy	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Minimally Invasive Esophagectomy in Prone or Left Decubitus Position: A Prospective Randomized Clinical Trial From A Single Institution
• Study Start Date: Jul 1, 2010
• Anticipated Primary Completion Date: Dec 1, 2013
• Anticipated Study Completion Date: Dec 1, 2016

Outcome Measures

Primary Outcome Measures

1. Perioperative morbidity and mortality from the two groups [1 -5 years after surgery]

Secondary Outcome Measures

1. short-term quality of life(postoperative 6 months and 1 year) between the two groups [1 year]

2. 3-and 5-year survival rate between the two groups [1 - 5 years after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhong Shan Hospital, Fu Dan University	Shanghai		China	200032

Sponsors and Collaborators

• Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01144325
• Other Study ID Numbers: ZSchest2010001; MIEFUDANU2010001
• First Posted: Jun 15, 2010
• Last Update Posted: Mar 8, 2011
• Last Verified: Feb 1, 2011

• Keywords provided by , ,: Minimally Invasive Esophagectomy

Study Results

No Results Posted as of Mar 8, 2011