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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01144325
• Other study ID #: ZSchest2010001
• Secondary ID: MIEFUDANU2010001
• Status: Recruiting
• Phase: Phase 2
• First received: May 26, 2010
• Last updated: March 7, 2011
• Start date: July 2010
• Est. completion date: December 2016

Study information

• Verified date: February 2011
• Source: Fudan University
• Contact: Lijie Tan, MD
• Phone: 86-21-64041990
• Email: tan.lijie[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: December 2016
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Esophagectomy

Intervention

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.

Locations

Country	Name	City	State
China	Zhong Shan Hospital, Fu Dan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative morbidity and mortality from the two groups		1 —5 years after surgery	Yes
Secondary	short-term quality of life(postoperative 6 months and 1 year) between the two groups		1 year	Yes
Secondary	3-and 5-year survival rate between the two groups		1 - 5 years after surgery	Yes