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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Fudan University

Tracking Information
First Submitted Date  ICMJE May 26, 2010
First Posted Date  ICMJE June 15, 2010
Last Update Posted Date March 8, 2011
Study Start Date  ICMJE July 2010
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2011)
Perioperative morbidity and mortality from the two groups [ Time Frame: 1 —5 years after surgery ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 14, 2010)
1、Perioperative morbidity and mortality from the two groups; 2、3-and 5-year survival rate between the two groups [ Time Frame: 1 —5 years after surgery ]
Change History Complete list of historical versions of study NCT01144325 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2011)
  • short-term quality of life(postoperative 6 months and 1 year) between the two groups [ Time Frame: 1 year ]
  • 3-and 5-year survival rate between the two groups [ Time Frame: 1 - 5 years after surgery ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2010)
short-term quality of life(postoperative 6 months and 1 year) between the two groups [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Minimally Invasive Esophagectomy (MIE) in Prone Versus Left Decubitus Position
Official Title  ICMJE Minimally Invasive Esophagectomy in Prone or Left Decubitus Position: A Prospective Randomized Clinical Trial From A Single Institution
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Esophageal Cancer
  • Esophagectomy
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 14, 2010)
2
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01144325
Other Study ID Numbers  ICMJE ZSchest2010001
MIEFUDANU2010001 ( Other Identifier: Zhong Shan Hospital, Fu Dan University )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tan, Lijie MD / Associate Professor of Surgery, Division of Thoracic Surgery, Zhong Shan Hospital
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fudan University
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP