Lung CancerVOLONCT02910453
VATS Versus Open Pulmonary Lobectomy in the Limelight of OEP
An observational study of Lung Cancer, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
The standard operative approach to pulmonary lesions has been via postero-lateral thoracotomy and direct vision. This technique has some advantages but its morbidity is significant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Pulmonary lobectomy
- Type of treatment
- Surgery or procedure
- How many people
- 78 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Dec 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung cancer patients suitable for pulmonary lobectomy.
Who may be able to join
- Lesion not in close relation to the hilar structures (bronchus, vessels) based on CT
- Non-Small Cell Lung Cancer clinically staged T1-2, N0 or N1, M0
- Subject must be able to tolerate general anesthesia and have cardiopulmonary reserve to tolerate a lobectomy
Who cannot join
- Previous thoracic surgery on same side
- Planned segment resection or pneumonectomy
- Any type of chronic pain, requiring daily use of analgesics
- Body Mass Index (BMI) ≥ 35
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VATS Versus Open Pulmonary Lobectomy for Lung Cancer: a Prospective Analysis of Different Impacts on Ribcage Kinematics With Optoelectronic Plethysmography
The standard operative approach to pulmonary lesions has been via postero-lateral thoracotomy and direct vision. This technique has some advantages but its morbidity is significant. Some surgeons advocate a resection by video-assisted thoracic surgery (VATS) to reduce the impact on chest wall and the impairment on respiratory mechanic. However, an evidence for superiority of the approach minimally invasive is lacking, particularly for the difficult assessment of the change in pulmonary function. The aim of this study is to compare VATS- over open lobectomy regarding the differences of chest wall kinematic, analyzed by optoelectronic plethysmography (OEP).
Read the detailed description
Rationale: The standard operative approach to pulmonary lesions has been via postero-lateral thoracotomy and direct vision. This technique has some advantages but its morbidity is significant. Some surgeons advocate a resection by video-assisted thoracic surgery (VATS) to reduce the impact on chest wall and the impairment on respiratory mechanic. However, an evidence for superiority of the approach minimally invasive is lacking, particularly for the difficult assessment of the change in pulmonary function and its relation with chest wall modifications.
Objective: The aim of this study is to compare VATS- over open lobectomy regarding the differences of chest wall kinematic analyzed by optoelectronic plethysmography (OEP).
Study design: A prospective mono-centre single blind trial. Study population: Adult patients of either gender candidate for pulmonary lobectomy for non small cell lung cancer.
Intervention: Patients are submitted to pulmonary lobectomy by video-assisted technique or by postero-lateral thoracotomy. This decision follows the usual clinical evaluations, regardless of whether or not the study enrollment. In particular, they are candidates for postero-lateral thoracotomy if: tumors were close to the hilum or other relevant anatomical structures, or the computed tomography demonstrated hilar calcific lymph-nodes or the lesions were of greater than 4 cm diameter.
Endpoint is evaluation of modification of respiratory kinematic after pulmonary lobectomy, assessed by OEP. In particular, the volume variation of pulmonary rib cage of the treated side versus the relative untreated side and the differences. Respiratory movements and thoracic and abdominal volume changes will be recorded continuously by analyzing the movements of retro-reflective markers using 8 video-cameras connected to an automatic optoelectronic motion analyzer. Subjects are prepared for OEP (markers). Baseline spirometry is take prior to exercise test. All exercise take place on an electromagnetically braked cycle-ergometer. Throughout the protocol heart rate, oxygen saturation and dyspnoea with the Borg scale are recorded. Ventilatory kinematics are monitored throughout exercise using OEP. This OEP analysis involves compartmentalization of the chest into three sections: pulmonary rib cage, abdominal rib cage, and abdomen to determine the contribution of each component to total chest wall volume.
- Conditions
- Lung Cancer
- Being tested
- Pulmonary lobectomy
- Keywords
- Pulmonary lobectomy, Video-Assisted Thoracic Surgery, Opto-electronic plethysmography, Posterolateral thoracotomy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary lobectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| VATS group | Pulmonary lobectomy via VATS. VATS starts with a utility incision, approximately 4 cm in length, anterior to the latissimus dorsi muscle at the 4th intercostal space. Muscle fibers are split without cutting and a wound protector is regularly placed in site. The camera port is placed in the 6th or 7th intercostal space at the anterior axillary line and a third 10-mm access is made at the same intercostal space at the posterior axillary line. The hilum is approached anteriorly Receives: Procedure: Pulmonary lobectomy | |
| Open group | Pulmonary lobectomy via posterolateral thoracotomy (PLT). PLT consists in a standard 10-15 muscle-sparing incision at 4th intercostal space, rib divaricators are utilized and the hilum is approached posteriorly as previously described Receives: Procedure: Pulmonary lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modification of respiratory kinematic
Compare VATS- over open pulmonary lobectomy regarding the differences of chest wall kinematic, analyzed by optoelectronic plethysmography (OEP)
Measured: T0: preoperatively (2 weeks before surgery); T1: 1 week after surgery; T2: 2 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Politecnico di Milano
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910453
- Sponsor's protocol ID
- VOLO-2016-2583
- Acronym
- VOLO
- Status last verified
- Sep 2016
- First submitted
- 9 Sep 2016
- Last updated
- 7 May 2021
- Results posted
- No
Publications
LoMauro A, Aliverti A, Chiesa M, Cattaneo M, Privitera E, Tosi D, Nosotti M, Santambrogio L, Palleschi A. Ribcage kinematics during exercise justifies thoracoscopic versus postero-lateral thoracotomy lobectomy prompt recovery. Eur J Cardiothorac Surg. 2017 Dec 1;52(6):1197-1205. doi: 10.1093/ejcts/ezx174.
PubMed 28977548
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VATS Versus Open Pulmonary Lobectomy for Lung Cancer: a Prospective Analysis of Different Impacts on Ribcage Kinematics With Optoelectronic Plethysmography
- ClinicalTrials.gov ID
- NCT02910453
- Acronym / sponsor ID
- VOLO / VOLO-2016-2583
- Conditions
- Lung Cancer
- Keywords
- Pulmonary lobectomy, Video-Assisted Thoracic Surgery, Opto-electronic plethysmography, Posterolateral thoracotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- Politecnico di Milano
- Study start
- Jan 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Sep 2016 (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 standard operative approach to pulmonary lesions has been via postero-lateral thoracotomy and direct vision. This technique has some advantages but its morbidity is significant. Some surgeons advocate a resection by video-assisted thoracic surgery (VATS) to reduce the impact on chest wall and the impairment on respiratory mechanic. However, an evidence for superiority of the approach minimally invasive is lacking, particularly for the difficult assessment of the change in pulmonary function. The aim of this study is to compare VATS- over open lobectomy regarding the differences of chest wall kinematic, analyzed by optoelectronic plethysmography (OEP).
Detailed description
Rationale: The standard operative approach to pulmonary lesions has been via postero-lateral thoracotomy and direct vision. This technique has some advantages but its morbidity is significant. Some surgeons advocate a resection by video-assisted thoracic surgery (VATS) to reduce the impact on chest wall and the impairment on respiratory mechanic. However, an evidence for superiority of the approach minimally invasive is lacking, particularly for the difficult assessment of the change in pulmonary function and its relation with chest wall modifications.
Objective: The aim of this study is to compare VATS- over open lobectomy regarding the differences of chest wall kinematic analyzed by optoelectronic plethysmography (OEP).
Study design: A prospective mono-centre single blind trial. Study population: Adult patients of either gender candidate for pulmonary lobectomy for non small cell lung cancer.
Intervention: Patients are submitted to pulmonary lobectomy by video-assisted technique or by postero-lateral thoracotomy. This decision follows the usual clinical evaluations, regardless of whether or not the study enrollment. In particular, they are candidates for postero-lateral thoracotomy if: tumors were close to the hilum or other relevant anatomical structures, or the computed tomography demonstrated hilar calcific lymph-nodes or the lesions were of greater than 4 cm diameter.
Endpoint is evaluation of modification of respiratory kinematic after pulmonary lobectomy, assessed by OEP. In particular, the volume variation of pulmonary rib cage of the treated side versus the relative untreated side and the differences. Respiratory movements and thoracic and abdominal volume changes will be recorded continuously by analyzing the movements of retro-reflective markers using 8 video-cameras connected to an automatic optoelectronic motion analyzer. Subjects are prepared for OEP (markers). Baseline spirometry is take prior to exercise test. All exercise take place on an electromagnetically braked cycle-ergometer. Throughout the protocol heart rate, oxygen saturation and dyspnoea with the Borg scale are recorded. Ventilatory kinematics are monitored throughout exercise using OEP. This OEP analysis involves compartmentalization of the chest into three sections: pulmonary rib cage, abdominal rib cage, and abdomen to determine the contribution of each component to total chest wall volume.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VATS group | – | Procedure: Pulmonary lobectomyPulmonary lobectomy via VATS. VATS starts with a utility incision, approximately 4 cm in length, anterior to the latissimus dorsi muscle at the 4th intercostal space. Muscle fibers are split without cutting and a wound protector is regularly placed in site. The camera port is placed in the 6th or 7th intercostal space at the anterior axillary line and a third 10-mm access is made at the same intercostal space at the posterior axillary line. The hilum is approached anteriorly |
| Open group | – | Procedure: Pulmonary lobectomyPulmonary lobectomy via posterolateral thoracotomy (PLT). PLT consists in a standard 10-15 muscle-sparing incision at 4th intercostal space, rib divaricators are utilized and the hilum is approached posteriorly as previously described |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients suitable for pulmonary lobectomy.
Key inclusion criteria (3 listed)
- Lesion not in close relation to the hilar structures (bronchus, vessels) based on CT
- Non-Small Cell Lung Cancer clinically staged T1-2, N0 or N1, M0
- Subject must be able to tolerate general anesthesia and have cardiopulmonary reserve to tolerate a lobectomy
Key exclusion criteria (4 listed)
- Previous thoracic surgery on same side
- Planned segment resection or pneumonectomy
- Any type of chronic pain, requiring daily use of analgesics
- Body Mass Index (BMI) ≥ 35
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 |
|---|---|---|
| Pulmonary lobectomy | Procedure or surgery | Open group, VATS group |
Primary outcome
Modification of respiratory kinematic
Time frame: T0: preoperatively (2 weeks before surgery); T1: 1 week after surgery; T2: 2 months after surgery
Compare VATS- over open pulmonary lobectomy regarding the differences of chest wall kinematic, analyzed by optoelectronic plethysmography (OEP)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Derived from this study: PubMed 28977548LoMauro A, Aliverti A, Chiesa M, Cattaneo M, Privitera E, Tosi D, Nosotti M, Santambrogio L, Palleschi A. Ribcage kinematics during exercise justifies thoracoscopic versus postero-lateral thoracotomy lobectomy prompt recovery. Eur J Cardiothorac Surg. 2017 Dec 1;52(6):1197-1205. doi: 10.1093/ejcts/ezx174.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 7 May 2021. 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 Italy. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modification of respiratory kinematic (time frame: T0: preoperatively (2 weeks before surgery); T1: 1 week after surgery; T2: 2 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02910453, which also lists 1 linked publication.
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 7 May 2021.