Lung CancerNCT03240250
Randomized Study on Effects of Uniportal VATS Versus Triportal VATS
An observational study of Lung Cancer, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
For the treatment of stage I-II NSCLC, two mini-invasive techniques are mostly utilized: uni-portal and three-portal VATS. In the uniportal approach, the injury on a single intercostal space could determine a lower level of pain than the three-portal approach, allowing a better postoperative course. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- VATS uni-portal lobectomy and lymphoadenectomy and VATS three-portal lobectomy and lymphoadenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 12 Mar 2017to 1 Oct 2020
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinical diagnosis of NSCLC, stage I-II, age 30-75, who undergo pulmonary lobectomy and limphadenectomy with radical intent
Who may be able to join
- Patients with cT1-2N0-1M0 NSCLC, maximum diameter 5cm
- ASA (American Society of Anestesiology) score 1-2-3
Who cannot join
- N2-N3 disease
- Induction chemotherapy
- Thoracic wall infiltration
- Previous thoracic surgery
- Important pleural adhesions
- Severe COPD, asthma, interstitial lung disease - Liver, kidney or cardiac failure
Show all 11Show fewer
- Clotting disorders
- Analgesic allergy
- Sublobar resection, sleeve lobectomy, pneumonectomy
- Chronic analgesic, oppioids or cortisonic use
- Absence of informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Thoracic Surgery Unit - Fondazione IRCCS Ca' Granda Policlinico
Milan, Mi, 20100
About this study
Official title: Randomized Study on Effects of Uniportal VATS Versus Triportal VATS for the Treatment of Stage I-II NSCLC
For the treatment of stage I-II NSCLC, two mini-invasive techniques are mostly utilized: uni-portal and three-portal VATS. In the uniportal approach, the injury on a single intercostal space could determine a lower level of pain than the three-portal approach, allowing a better postoperative course. Few studies in Literature compare these techniques, and most of them are retrospective.
The main purpose of this randomized study is to compare uni-portal VATS with three-portal VATS, in terms of postoperative pain.
Read more
Secondary objectives of the study are valutations of:
- respiratory and functional capacity between the two groups
- operative time
- number of resected lymphnodes
- intra and postoperative complications, such as conversions to open surgery, amount of bleeding, prolonged air leaks, surgical site infections, pulmonary complications.
Read the detailed description
Randomized cohort clinical trial, prospectic, monocentric. Procedure of randomization: the day before the operation, with the "Random Allocation Rule" technique
Arm 1: pulmonary lobectomy and lymphoadenectomy with uni-portal VATS approach
Arm 2: pulmonary lobectomy and lymphoadenectomy with three-portal VATS approach
Misurations Total analgesic consumption, normalized to morphine milligrams, recorded in the 7 days following the operation.
The choice of cumulative analgesic consumption as parameter of primary outcome is because pain valuation with VAS is significantly affected by individual variability.
Secondary outcomes: measure of postoperative pain with NRS at 2,6,12,24 hours and at 2,3,4,5,30 days from sugery. A pain score will be assigned to each patient after the total amount of NRS.
Respiratory function will be valuated with spirometry after 7 and 30 days from surgery, and compared with pre-operative tests.
All intraoperative parameters will be compared between the two groups: operative time (skin to skin), proportion of conversions to open surgery, number of resected lymphnodes, amount of bleeding.
Postoperative complications will be analyzed: rate of prolonged air leaks, surgical site infections, cardiac rythhm disfunctions, pulmonary complications, post-thoracotomy syndrome, as well as lenght of stay at the hospital.
- Conditions
- Lung Cancer
- Being tested
- VATS uni-portal lobectomy and lymphoadenectomy, VATS three-portal lobectomy and lymphoadenectomy
- Keywords
- VATS, Pulmonary lobectomy, Uniportal, Postoperative pain, Thoracic surgery
- Medical subject headings
- Lung Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VATS uni-portal lobectomy and lymphoadenectomyProcedure or surgery
VATS uni-portal lobectomy and lymphoadenectomy
VATS three-portal lobectomy and lymphoadenectomyProcedure or surgery
VATS three-portal lobectomy and lymphoadenectomy, Copenhagen approach
| Study group | Role | What they receive |
|---|---|---|
| Uni-portal VATS | VATS uni-portal lobectomy and lymphoadenectomy Receives: Procedure: VATS uni-portal lobectomy and lymphoadenectomy | |
| Three-portal VATS | VATS three-portal lobectomy and lymphoadenectomy Receives: Procedure: VATS three-portal lobectomy and lymphoadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of postoperative pain after uni-portal and three-portal VATS
Total analgesic consumption, normalized to morphine milligrams, recorded in the 7 days following the operation.
Measured: 7 days
Secondary outcomes (6)
Measure of postoperative pain with NRS at 2,6,12,24 hours and at 2,3,4,5,30 days from sugery.
A pain score will be assigned to each patient after the total amount of NRS
Measured: 30 days
Valuation of respiratory function
Spirometry after 7 and 30 days from surgery, compared with pre-operative tests
Measured: 30 days
Intraoperative parameters
Operative time (skin to skin, minutes)
Measured: 1 day
Intraoperative bleeding
Amount of bleeding
Measured: 1 day
Postoperative air leakage
Rate of prolonged air leaks
Measured: 15 days
Postoperative complications
Cardiac rythhm disfunctions
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start12 Mar 2017
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Davide Tosi, Principal investigator, Fondazione Ca' Granda IRCCS Policlinico Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240250
- Sponsor's protocol ID
- 3564
- Status last verified
- Aug 2017
- First submitted
- 13 Jul 2017
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mendogni P, Mazzucco A, Palleschi A, Rosso L, Righi I, Carrinola R, Damarco F, Privitera E, Fumagalli J, Bonitta G, Nosotti M, Tosi D. Uniportal and three-portal video-assisted thoracic surgery pulmonary lobectomy for early-stage lung cancer (UNIT trial): study protocol of a single-center randomized trial. Trials. 2021 Feb 25;22(1):163. doi: 10.1186/s13063-021-05115-w.
PubMed 33632284
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study on Effects of Uniportal VATS Versus Triportal VATS for the Treatment of Stage I-II NSCLC
- ClinicalTrials.gov ID
- NCT03240250
- Acronym / sponsor ID
- 3564
- Conditions
- Lung Cancer
- Keywords
- VATS, Pulmonary lobectomy, Uniportal, Postoperative pain, Thoracic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 12 Mar 2017 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 7 Aug 2017 (actual)
- 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.
For the treatment of stage I-II NSCLC, two mini-invasive techniques are mostly utilized: uni-portal and three-portal VATS. In the uniportal approach, the injury on a single intercostal space could determine a lower level of pain than the three-portal approach, allowing a better postoperative course. Few studies in Literature compare these techniques, and most of them are retrospective.
The main purpose of this randomized study is to compare uni-portal VATS with three-portal VATS, in terms of postoperative pain.
Secondary objectives of the study are valutations of:
- respiratory and functional capacity between the two groups
- operative time
- number of resected lymphnodes
- intra and postoperative complications, such as conversions to open surgery, amount of bleeding, prolonged air leaks, surgical site infections, pulmonary complications.
Detailed description
Randomized cohort clinical trial, prospectic, monocentric. Procedure of randomization: the day before the operation, with the "Random Allocation Rule" technique
Arm 1: pulmonary lobectomy and lymphoadenectomy with uni-portal VATS approach
Arm 2: pulmonary lobectomy and lymphoadenectomy with three-portal VATS approach
Misurations Total analgesic consumption, normalized to morphine milligrams, recorded in the 7 days following the operation.
The choice of cumulative analgesic consumption as parameter of primary outcome is because pain valuation with VAS is significantly affected by individual variability.
Secondary outcomes: measure of postoperative pain with NRS at 2,6,12,24 hours and at 2,3,4,5,30 days from sugery. A pain score will be assigned to each patient after the total amount of NRS.
Respiratory function will be valuated with spirometry after 7 and 30 days from surgery, and compared with pre-operative tests.
All intraoperative parameters will be compared between the two groups: operative time (skin to skin), proportion of conversions to open surgery, number of resected lymphnodes, amount of bleeding.
Postoperative complications will be analyzed: rate of prolonged air leaks, surgical site infections, cardiac rythhm disfunctions, pulmonary complications, post-thoracotomy syndrome, as well as lenght of stay at the hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uni-portal VATS | – | Procedure: VATS uni-portal lobectomy and lymphoadenectomyVATS uni-portal lobectomy and lymphoadenectomy |
| Three-portal VATS | – | Procedure: VATS three-portal lobectomy and lymphoadenectomyVATS three-portal lobectomy and lymphoadenectomy |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical diagnosis of NSCLC, stage I-II, age 30-75, who undergo pulmonary lobectomy and limphadenectomy with radical intent
Key inclusion criteria (2 listed)
- Patients with cT1-2N0-1M0 NSCLC, maximum diameter 5cm
- ASA (American Society of Anestesiology) score 1-2-3
Key exclusion criteria (11 listed)
- N2-N3 disease
- Induction chemotherapy
- Thoracic wall infiltration
- Previous thoracic surgery
- Important pleural adhesions
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 |
|---|---|---|
| VATS uni-portal lobectomy and lymphoadenectomyVATS uni-portal lobectomy and lymphoadenectomy | Procedure or surgery | Uni-portal VATS |
| VATS three-portal lobectomy and lymphoadenectomyVATS three-portal lobectomy and lymphoadenectomy, Copenhagen approach | Procedure or surgery | Three-portal VATS |
Primary outcome
Measurement of postoperative pain after uni-portal and three-portal VATS
Time frame: 7 days
Total analgesic consumption, normalized to morphine milligrams, recorded in the 7 days following the operation.
6 secondary outcomes
Measure of postoperative pain with NRS at 2,6,12,24 hours and at 2,3,4,5,30 days from sugery.
Time frame: 30 days
Valuation of respiratory function
Time frame: 30 days
Intraoperative parameters
Time frame: 1 day
Intraoperative bleeding
Time frame: 1 day
Postoperative air leakage
Time frame: 15 days
Postoperative complications
Time frame: 1 month
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 9 Feb 2021.
- Derived from this study: PubMed 33632284Mendogni P, Mazzucco A, Palleschi A, Rosso L, Righi I, Carrinola R, Damarco F, Privitera E, Fumagalli J, Bonitta G, Nosotti M, Tosi D. Uniportal and three-portal video-assisted thoracic surgery pulmonary lobectomy for early-stage lung cancer (UNIT trial): study protocol of a single-center randomized trial. Trials. 2021 Feb 25;22(1):163. doi: 10.1186/s13063-021-05115-w.
- Individual participant dataSharing planned: No
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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.
Davide Tosi principal investigator
Fondazione Ca' Granda IRCCS Policlinico Milan
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 2 inclusion and 11 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 9 Feb 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?
Measurement of postoperative pain after uni-portal and three-portal VATS (time frame: 7 days). 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 NCT03240250, 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 9 Feb 2021.