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

NCT01144325 | Unknown Phase 2 DMC

• 2 other identifiers: ZSchest2010001MIEFUDANU2010001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Conditions

Esophageal Cancer; Esophagectomy

Keywords

Minimally Invasive Esophagectomy

Outcome Measures

Primary Outcomes (1)

• Perioperative morbidity and mortality from the two groups

  1 -5 years after surgery

Secondary Outcomes (2)

• short-term quality of life(postoperative 6 months and 1 year) between the two groups

  1 year

• 3-and 5-year survival rate between the two groups

  1 - 5 years after surgery

Interventions

thoracoscopic esophagectomy PROCEDURE

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.

Also known as: MInimally invasive esophagectomy

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who received neoadjuvant therapy
• Mental disorders

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhong Shan Hospital, Fu Dan University

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Lijie Tan, MD

CONTACT

86-21-64041990; tan.lijie@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: June 15, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2016
• Last Updated: March 8, 2011

Record last verified: 2011-02

Locations

CN (1)