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Minimally Invasive Esophagectomy (MIE) in Prone Versus Left Decubitus Position
Conditions
Esophageal Cancer - Esophagectomy
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
Minimally Invasive Esophagectomy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Intervention
Name: thoracoscopic esophagectomy
Type: Procedure
Overall Status
Recruiting
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
- 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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 35 Years
Gender: Both
Criteria: 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
- 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
Location
Zhong Shan Hospital, Fu Dan University
Shanghai, China
Status: Recruiting
Start Date
July 2010
Completion Date
December 2016
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page