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Trial Title:
Minimally Invasive Esophagectomy (MIE) in Prone Versus Left Decubitus Position
NCT ID:
NCT01144325
Condition:
Esophageal Cancer
Esophagectomy
Conditions: Keywords:
Minimally Invasive Esophagectomy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Investigator)
Intervention:
Intervention type:
Procedure
Intervention name:
thoracoscopic esophagectomy
Description:
In prone position group, patients are intubated with single lumen endotracheal tube.
Surgeon and assistant stand on the right of the patient. A 10 mm camera port is placed
7th intercostals space in posterior axillary line, CO2 pneumothorax is created with
pressure of 8mmHg. A 5 mm port is placed just posterior to the scapular tip. The last
10mm port is placed at 9th intercostals space in the scapular line for. The tumor and
esophagus are dissected with cleaning of the lymph nodes along bilateral recurrent nerve.
In controlling group, The four chest ports were similar to that described by the
University of Pittsburgh group. The left two ports are used for surgical exposure, the
right two ports is to divide and dissect the esophagus. The dissection is similar to that
of the prone position.
Other name:
MInimally invasive esophagectomy
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
35 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhong Shan Hospital, Fu Dan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Start date:
July 2010
Completion date:
December 2016
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01144325
