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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


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
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