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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01144325
Recruitment Status : Unknown
Verified February 2011 by Fudan University.
Recruitment status was:  Recruiting
First Posted : June 15, 2010
Last Update Posted : March 8, 2011
Information provided by:
Fudan University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Intervention Details:
  • Procedure: thoracoscopic esophagectomy

    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

Primary Outcome Measures :
  1. Perioperative morbidity and mortality from the two groups [ Time Frame: 1 -5 years after surgery ]

Secondary Outcome Measures :
  1. short-term quality of life(postoperative 6 months and 1 year) between the two groups [ Time Frame: 1 year ]
  2. 3-and 5-year survival rate between the two groups [ Time Frame: 1 - 5 years after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01144325

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Contact: Lijie Tan, MD 86-21-64041990 ext 2559

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Zhong Shan Hospital, Fu Dan University Recruiting
Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
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Responsible Party: Tan, Lijie MD / Associate Professor of Surgery, Division of Thoracic Surgery, Zhong Shan Hospital Identifier: NCT01144325    
Other Study ID Numbers: ZSchest2010001
MIEFUDANU2010001 ( Other Identifier: Zhong Shan Hospital, Fu Dan University )
First Posted: June 15, 2010    Key Record Dates
Last Update Posted: March 8, 2011
Last Verified: February 2011
Keywords provided by Fudan University:
Minimally Invasive Esophagectomy