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


Phase 2
35 Years
70 Years
Open (Enrolling)
Both
Esophageal Cancer, Esophagectomy

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Perioperative morbidity and mortality from the two groups

Outcome Time Frame:

1 —5 years after surgery

Safety Issue:

Yes

Authority:

China: Ministry of Health

Study ID:

ZSchest2010001

NCT ID:

NCT01144325

Start Date:

July 2010

Completion Date:

December 2016

Related Keywords:

  • Esophageal Cancer
  • Esophagectomy
  • Minimally Invasive Esophagectomy
  • Esophageal Diseases
  • Esophageal Neoplasms

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