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

NCT ID: NCT01144325

Last Updated: 2011-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2016-12-31

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.

Conditions

Esophageal Cancer; Esophagectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

MInimally invasive esophagectomy

Eligibility 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Division of Thoracic Surgery, Zhong Shan Hospital

Locations

Zhong Shan Hospital, Fu Dan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Lijie Tan, MD

Role: CONTACT

tan.lijie@zs-hospital.sh.cn

86-21-64041990 ext. 2559

Other Identifiers

MIEFUDANU2010001

Identifier Type: OTHER

Identifier Source: secondary_id

ZSchest2010001

Identifier Type: -

Identifier Source: org_study_id