Esophageal CancerPhase 2NCT01144325
Minimally Invasive Esophagectomy (MIE) in Prone Versus Left Decubitus Position
A Phase 2 study testing thoracoscopic esophagectomy in people with Esophageal Cancer and Esophagectomy, run by Fudan University at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Esophageal Cancer, Esophagectomy
- What is being tested?
- thoracoscopic esophagectomy
- Type of treatment
- Surgery or procedure
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- Jul 2010to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who received neoadjuvant therapy
- Mental disorders
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhong Shan Hospital, Fu Dan University
Shanghai, 200032
About this study
Official title: Minimally Invasive Esophagectomy in Prone or Left Decubitus Position: A Prospective Randomized Clinical Trial From A Single Institution
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
Read the 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
- Being tested
- thoracoscopic esophagectomy
- Keywords
- Minimally Invasive Esophagectomy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracoscopic esophagectomyProcedure or surgery
Also called MInimally invasive 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative morbidity and mortality from the two groups
Measured: 1 -5 years after surgery
Secondary outcomes (2)
short-term quality of life(postoperative 6 months and 1 year) between the two groups
Measured: 1 year
3-and 5-year survival rate between the two groups
Measured: 1 - 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2013 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144325
- Sponsor's protocol ID
- ZSchest2010001
- Other IDs
- MIEFUDANU2010001
- Status last verified
- Feb 2011
- First submitted
- 26 May 2010
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Esophagectomy in Prone or Left Decubitus Position: A Prospective Randomized Clinical Trial From A Single Institution
- ClinicalTrials.gov ID
- NCT01144325
- Acronym / sponsor ID
- ZSchest2010001
- Conditions
- Esophageal Cancer, Esophagectomy
- Keywords
- Minimally Invasive Esophagectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 15 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who received neoadjuvant therapy
- Mental disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thoracoscopic esophagectomyAlso: MInimally invasive esophagectomyIn 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. | Procedure or surgery | – |
Primary outcome
Perioperative morbidity and mortality from the two groups
Time frame: 1 -5 years after surgery
2 secondary outcomes
short-term quality of life(postoperative 6 months and 1 year) between the two groups
Time frame: 1 year
3-and 5-year survival rate between the two groups
Time frame: 1 - 5 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing thoracoscopic esophagectomy in people with Esophageal Cancer and Esophagectomy, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lijie Tan, MD (86-21-64041990 ext. 2559, tan.lijie@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative morbidity and mortality from the two groups (time frame: 1 -5 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2011.