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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2011 by Fudan University
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01144325
First received: May 26, 2010
Last updated: March 7, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Esophageal Cancer
Esophagectomy
Procedure: thoracoscopic esophagectomy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Minimally Invasive Esophagectomy in Prone or Left Decubitus Position: A Prospective Randomized Clinical Trial From A Single Institution

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Perioperative morbidity and mortality from the two groups [ Time Frame: 1 —5 years after surgery ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 2
Study Start Date: July 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144325

Contacts
Contact: Lijie Tan, MD 86-21-64041990 ext 2559 tan.lijie@zs-hospital.sh.cn

Locations
China
Zhong Shan Hospital, Fu Dan University Recruiting
Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
  More Information

No publications provided

Responsible Party: Tan, Lijie MD / Associate Professor of Surgery, Division of Thoracic Surgery, Zhong Shan Hospital
ClinicalTrials.gov Identifier: NCT01144325     History of Changes
Other Study ID Numbers: ZSchest2010001, MIEFUDANU2010001
Study First Received: May 26, 2010
Last Updated: March 7, 2011
Health Authority: China: Ministry of Health

Keywords provided by Fudan University:
Minimally Invasive Esophagectomy

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on July 29, 2014