Lung CancerPATCHESNCT05716815
Prospective rAndomized sTudy efficaCy tHree-dimensional rEconstructions Segmentectomy
A study testing CT scans 2D Reconstruction and CT scans 2D plus 3D Reconstruction in people with Lung Cancer and Lung; Node, run by Ospedale Centrale Bolzano.
Trial summary
With this project we want to study the effectiveness of 3D reconstruction of preoperative CT to reduce operating times, blood loss and conversions after segmentectomy performed in thoracoscopy / robotics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lung; Node
- What is being tested?
- CT scans 2D Reconstruction and CT scans 2D plus 3D Reconstruction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 May 2026
- Phase
- Interventional
- 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
Who may be able to join
- Segmentectomy performed through a minimally invasive approach (VATS or RATS).
- Pathologically proven NSCLC on the resected specimen.
- Age ≥18
- Signed written informed consent
Who cannot join
- Prior homolateral cardiothoracic surgery.
- Allergy or any other contraindication to iodinated contrast media.
- Segmentectomy performed through an open approach (thoracotomy)
- Histology different than NSCLC.
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Randomized Study on the Efficacy of Three-dimensional Reconstructions of Bronchial and Vascular Structures on Preoperative Chest CT Scan in Patients Who Are Candidates for Pulmonary Segmentectomy Surgery
With this project we want to study the effectiveness of 3D reconstruction of preoperative CT to reduce operating times, blood loss and conversions after segmentectomy performed in thoracoscopy / robotics.
Read the detailed description
Pulmonary segmentectomy is the surgery of first choice in malignant lung tumors with a diameter <2 cm in diameter. Patients who are candidates for this type of treatment perform usually a preoperative CT scan with two-dimensional reconstructions (2D: axial, coronary and sagittal). Today it is possible to perform a preoperative three-dimensional reconstruction (3D: volume rendering) of the vessels and bronchi using special software.
Objectives of the study is to analyze, in these patients, the benefits of 3D reconstruction of vessels and bronchi compared to 2D reconstruction, analyzing intra- and post-operative data.The study aims to randomize 288 patients over 36 months.
Study design: Prospective, randomized, controlled study. In 50% of patients the preoperative study of anatomical structures will be performed with the standard 2D method, in the remaining 50% with a 2D and 3D reconstruction. The assignment will take place through access to an online feature on the study website.
Evaluations and statistical methods The statistical analysis will be carried out using parametric and nonparametric descriptive, inferential statistical methods, while the main outcome will be carried out using the analysis of variance (ANOVA) and covariance (ANCOVA) techniques.
Ethical aspects. The study will be conducted in accordance with applicable current legislation. Approval by all relevant ethics committees will be required. Each patient will provide a written consent to participate in the study, after being properly informed.
- Conditions
- Lung Cancer, Lung; Node
- Being tested
- CT scans 2D Reconstruction, CT scans 2D plus 3D Reconstruction
- Keywords
- Lung Segmentectomy, CT 3D Recostruction, VATS, RATS
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scans 2D ReconstructionDiagnostic test
Before performing the surgery, patient performs a chest CT scan with contrast medium and standard two-dimensional (2D) reconstructions are performed to study the lesion, the anatomy of the bronchi and the pulmonary venous and arterial vessels.
CT scans 2D plus 3D ReconstructionDiagnostic test
Before performing the surgery, patient performs a chest CT scan with contrast medium and standard two-dimensional (2D) reconstructions plus a 3D reconstruction are performed to study the lesion, the anatomy of the bronchi and the pulmonary venous and arterial vessels.
| Study group | Role | What they receive |
|---|---|---|
| 2D Reconstruction | Active comparator | Before minimally invasive lung segmentectomy, preoperative chest CT scans are processed and evaluated with multi-plane (2D) reconstructions, according to the usual center protocol. Receives: Diagnostic Test: CT scans 2D Reconstruction |
| 2D plus 3D Reconstruction | Experimental | Before minimally invasive lung segmentectomy, preoperative chest CT scans are processed and evaluated with volume rendering (3D) reconstructions. Receives: Diagnostic Test: CT scans 2D plus 3D Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversions from minimally invasive to thoracotomic procedure
Evaluation of conversions from minimally invasive to thoracotomic procedure
Measured: Intraoperative
Margin- and disease-free resection
Margin- and disease-free resection
Measured: 1 Month postoperative
Secondary outcomes (6)
Operating times
Evaluation of operating times
Measured: Intraoperative
Intraoperative blood loss
Evaluation of intraoperative blood loss
Measured: Intraoperative
Intraoperative major bleeding
Intraoperative major bleeding
Measured: Intraoperative
Intraoperative air leaks and the use of sealants
Evaluation of intraoperative air leaks and the use of sealants
Measured: Intraoperative
Postoperative air leaks
Evaluation of postoperative air leaks
Measured: up to 2 weeks
Hospitalization times
Evaluation of hospitalization times
Measured: up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective multicenter randomized study
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Centrale Bolzano
- Sponsor type
- University, hospital or other
- Collaborators
- European Institute of Oncology, Philipps University Marburg, Ernst von Bergmann Hospital, Chinese University of Hong Kong, Wolfson Medical Center, University of Belgrade, Harvard University, University of Salamanca
- Responsible party
- Principal investigator, Francesco Zaraca, Ospedale Centrale Bolzano
- Investigators
- ZARACA FRANCESCO, Principal investigator, Central Hospital Bolzano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716815
- Sponsor's protocol ID
- 1-2023
- Acronym
- PATCHES
- Status last verified
- Aug 2023
- First submitted
- 11 Jan 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Allemani C, Matsuda T, Di Carlo V, Harewood R, Matz M, Niksic M, Bonaventure A, Valkov M, Johnson CJ, Esteve J, Ogunbiyi OJ, Azevedo E Silva G, Chen WQ, Eser S, Engholm G, Stiller CA, Monnereau A, Woods RR, Visser O, Lim GH, Aitken J, Weir HK, Coleman MP; CONCORD Working Group. Global surveillance of trends in cancer survival 2000-14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet. 2018 Mar 17;391(10125):1023-1075. doi: 10.1016/S0140-6736(17)33326-3. Epub 2018 Jan 31.
PubMed 29395269Zhao ZR, Situ DR, Lau RWH, Mok TSK, Chen GG, Underwood MJ, Ng CSH. Comparison of Segmentectomy and Lobectomy in Stage IA Adenocarcinomas. J Thorac Oncol. 2017 May;12(5):890-896. doi: 10.1016/j.jtho.2017.01.012. Epub 2017 Jan 20.
PubMed 28111235Suzuki K, Saji H, Aokage K, Watanabe SI, Okada M, Mizusawa J, Nakajima R, Tsuboi M, Nakamura S, Nakamura K, Mitsudomi T, Asamura H; West Japan Oncology Group; Japan Clinical Oncology Group. Comparison of pulmonary segmentectomy and lobectomy: Safety results of a randomized trial. J Thorac Cardiovasc Surg. 2019 Sep;158(3):895-907. doi: 10.1016/j.jtcvs.2019.03.090. Epub 2019 Apr 9.
PubMed 31078312Hung MH, Cheng YJ, Chan KC, Han SC, Chen KC, Hsu HH, Chen JS. Nonintubated uniportal thoracoscopic surgery for peripheral lung nodules. Ann Thorac Surg. 2014 Dec;98(6):1998-2003. doi: 10.1016/j.athoracsur.2014.07.036. Epub 2014 Oct 28.
PubMed 25443006Wu H, Jin R, Yang S, Park BJ, Li H. Long-term and short-term outcomes of robot- versus video-assisted anatomic lung resection in lung cancer: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2021 Apr 29;59(4):732-740. doi: 10.1093/ejcts/ezaa426.
PubMed 33367615Gharagozloo F, Margolis M, Tempesta B, Strother E, Najam F. Robot-assisted lobectomy for early-stage lung cancer: report of 100 consecutive cases. Ann Thorac Surg. 2009 Aug;88(2):380-4. doi: 10.1016/j.athoracsur.2009.04.039.
PubMed 19632377Nomori H, Mori T, Shiraishi A, Fujino K, Sato Y, Ito T, Suzuki M. Long-Term Prognosis After Segmentectomy for cT1 N0 M0 Non-Small Cell Lung Cancer. Ann Thorac Surg. 2019 May;107(5):1500-1506. doi: 10.1016/j.athoracsur.2018.11.046. Epub 2018 Dec 21.
PubMed 30579848Stiles BM, Mao J, Harrison S, Lee B, Port JL, Altorki NK, Sedrakyan A. Sublobar resection for node-negative lung cancer 2-5 cm in size. Eur J Cardiothorac Surg. 2019 Nov 1;56(5):858-866. doi: 10.1093/ejcts/ezz146.
PubMed 31168591Bao F, Ye P, Yang Y, Wang L, Zhang C, Lv X, Hu J. Segmentectomy or lobectomy for early stage lung cancer: a meta-analysis. Eur J Cardiothorac Surg. 2014 Jul;46(1):1-7. doi: 10.1093/ejcts/ezt554. Epub 2013 Dec 8.
PubMed 24321996Shimizu K, Nagashima T, Ohtaki Y, Obayashi K, Nakazawa S, Kamiyoshihara M, Igai H, Takeyoshi I, Mogi A, Kuwano H. Analysis of the variation pattern in right upper pulmonary veins and establishment of simplified vein models for anatomical segmentectomy. Gen Thorac Cardiovasc Surg. 2016 Oct;64(10):604-11. doi: 10.1007/s11748-016-0686-4. Epub 2016 Jul 19.
PubMed 27435809Akiba T. Utility of three-dimensional computed tomography in general thoracic surgery. Gen Thorac Cardiovasc Surg. 2013 Dec;61(12):676-84. doi: 10.1007/s11748-013-0336-z. Epub 2013 Oct 25.
PubMed 24158329Akiba T, Marushima H, Harada J, Kobayashi S, Morikawa T. Importance of preoperative imaging with 64-row three-dimensional multidetector computed tomography for safer video-assisted thoracic surgery in lung cancer. Surg Today. 2009;39(10):844-7. doi: 10.1007/s00595-009-3965-1. Epub 2009 Sep 27.
PubMed 19784721She XW, Gu YB, Xu C, Li C, Ding C, Chen J, Zhao J. Three-dimensional (3D)- computed tomography bronchography and angiography combined with 3D-video-assisted thoracic surgery (VATS) versus conventional 2D-VATS anatomic pulmonary segmentectomy for the treatment of non-small cell lung cancer. Thorac Cancer. 2018 Feb;9(2):305-309. doi: 10.1111/1759-7714.12585. Epub 2018 Jan 3.
PubMed 29297974Xue L, Fan H, Shi W, Ge D, Zhang Y, Wang Q, Yuan Y. Preoperative 3-dimensional computed tomography lung simulation before video-assisted thoracoscopic anatomic segmentectomy for ground glass opacity in lung. J Thorac Dis. 2018 Dec;10(12):6598-6605. doi: 10.21037/jtd.2018.10.126.
PubMed 30746205
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study on the Efficacy of Three-dimensional Reconstructions of Bronchial and Vascular Structures on Preoperative Chest CT Scan in Patients Who Are Candidates for Pulmonary Segmentectomy Surgery
- ClinicalTrials.gov ID
- NCT05716815
- Acronym / sponsor ID
- PATCHES / 1-2023
- Conditions
- Lung Cancer, Lung; Node
- Keywords
- Lung Segmentectomy, CT 3D Recostruction, VATS, RATS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Ospedale Centrale BolzanoUniversity, hospital or other
- Collaborators
- European Institute of Oncology, Philipps University Marburg, Ernst von Bergmann Hospital, Chinese University of Hong Kong, Wolfson Medical Center, University of Belgrade, Harvard University, University of Salamanca
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 8 Feb 2023 (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.
With this project we want to study the effectiveness of 3D reconstruction of preoperative CT to reduce operating times, blood loss and conversions after segmentectomy performed in thoracoscopy / robotics.
Detailed description
Pulmonary segmentectomy is the surgery of first choice in malignant lung tumors with a diameter <2 cm in diameter. Patients who are candidates for this type of treatment perform usually a preoperative CT scan with two-dimensional reconstructions (2D: axial, coronary and sagittal). Today it is possible to perform a preoperative three-dimensional reconstruction (3D: volume rendering) of the vessels and bronchi using special software.
Objectives of the study is to analyze, in these patients, the benefits of 3D reconstruction of vessels and bronchi compared to 2D reconstruction, analyzing intra- and post-operative data.The study aims to randomize 288 patients over 36 months.
Study design: Prospective, randomized, controlled study. In 50% of patients the preoperative study of anatomical structures will be performed with the standard 2D method, in the remaining 50% with a 2D and 3D reconstruction. The assignment will take place through access to an online feature on the study website.
Evaluations and statistical methods The statistical analysis will be carried out using parametric and nonparametric descriptive, inferential statistical methods, while the main outcome will be carried out using the analysis of variance (ANOVA) and covariance (ANCOVA) techniques.
Ethical aspects. The study will be conducted in accordance with applicable current legislation. Approval by all relevant ethics committees will be required. Each patient will provide a written consent to participate in the study, after being properly informed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective multicenter randomized study
| Arm | Type | Receives |
|---|---|---|
| 2D Reconstruction | Active comparator | Diagnostic Test: CT scans 2D ReconstructionBefore minimally invasive lung segmentectomy, preoperative chest CT scans are processed and evaluated with multi-plane (2D) reconstructions, according to the usual center protocol. |
| 2D plus 3D Reconstruction | Experimental | Diagnostic Test: CT scans 2D plus 3D ReconstructionBefore minimally invasive lung segmentectomy, preoperative chest CT scans are processed and evaluated with volume rendering (3D) reconstructions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Segmentectomy performed through a minimally invasive approach (VATS or RATS).
- Pathologically proven NSCLC on the resected specimen.
- Age ≥18
- Signed written informed consent
Key exclusion criteria (5 listed)
- Prior homolateral cardiothoracic surgery.
- Allergy or any other contraindication to iodinated contrast media.
- Segmentectomy performed through an open approach (thoracotomy)
- Histology different than NSCLC.
- Pregnancy
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 |
|---|---|---|
| CT scans 2D ReconstructionBefore performing the surgery, patient performs a chest CT scan with contrast medium and standard two-dimensional (2D) reconstructions are performed to study the lesion, the anatomy of the bronchi and the pulmonary venous and arterial vessels. | Diagnostic test | 2D Reconstruction |
| CT scans 2D plus 3D ReconstructionBefore performing the surgery, patient performs a chest CT scan with contrast medium and standard two-dimensional (2D) reconstructions plus a 3D reconstruction are performed to study the lesion, the anatomy of the bronchi and the pulmonary venous and arterial vessels. | Diagnostic test | 2D plus 3D Reconstruction |
Primary outcome
Conversions from minimally invasive to thoracotomic procedure
Time frame: Intraoperative
Evaluation of conversions from minimally invasive to thoracotomic procedure
Margin- and disease-free resection
Time frame: 1 Month postoperative
Margin- and disease-free resection
6 secondary outcomes
Operating times
Time frame: Intraoperative
Intraoperative blood loss
Time frame: Intraoperative
Intraoperative major bleeding
Time frame: Intraoperative
Intraoperative air leaks and the use of sealants
Time frame: Intraoperative
Postoperative air leaks
Time frame: up to 2 weeks
Hospitalization times
Time frame: up to 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 29395269Allemani C, Matsuda T, Di Carlo V, Harewood R, Matz M, Niksic M, Bonaventure A, Valkov M, Johnson CJ, Esteve J, Ogunbiyi OJ, Azevedo E Silva G, Chen WQ, Eser S, Engholm G, Stiller CA, Monnereau A, Woods RR, Visser O, Lim GH, Aitken J, Weir HK, Coleman MP; CONCORD Working Group. Global surveillance of trends in cancer survival 2000-14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet. 2018 Mar 17;391(10125):1023-1075. doi: 10.1016/S0140-6736(17)33326-3. Epub 2018 Jan 31.
- Background: PubMed 28111235Zhao ZR, Situ DR, Lau RWH, Mok TSK, Chen GG, Underwood MJ, Ng CSH. Comparison of Segmentectomy and Lobectomy in Stage IA Adenocarcinomas. J Thorac Oncol. 2017 May;12(5):890-896. doi: 10.1016/j.jtho.2017.01.012. Epub 2017 Jan 20.
- Background: PubMed 31078312Suzuki K, Saji H, Aokage K, Watanabe SI, Okada M, Mizusawa J, Nakajima R, Tsuboi M, Nakamura S, Nakamura K, Mitsudomi T, Asamura H; West Japan Oncology Group; Japan Clinical Oncology Group. Comparison of pulmonary segmentectomy and lobectomy: Safety results of a randomized trial. J Thorac Cardiovasc Surg. 2019 Sep;158(3):895-907. doi: 10.1016/j.jtcvs.2019.03.090. Epub 2019 Apr 9.
- Background: PubMed 25443006Hung MH, Cheng YJ, Chan KC, Han SC, Chen KC, Hsu HH, Chen JS. Nonintubated uniportal thoracoscopic surgery for peripheral lung nodules. Ann Thorac Surg. 2014 Dec;98(6):1998-2003. doi: 10.1016/j.athoracsur.2014.07.036. Epub 2014 Oct 28.
- Background: PubMed 33367615Wu H, Jin R, Yang S, Park BJ, Li H. Long-term and short-term outcomes of robot- versus video-assisted anatomic lung resection in lung cancer: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2021 Apr 29;59(4):732-740. doi: 10.1093/ejcts/ezaa426.
- Background: PubMed 19632377Gharagozloo F, Margolis M, Tempesta B, Strother E, Najam F. Robot-assisted lobectomy for early-stage lung cancer: report of 100 consecutive cases. Ann Thorac Surg. 2009 Aug;88(2):380-4. doi: 10.1016/j.athoracsur.2009.04.039.
- Background: PubMed 30579848Nomori H, Mori T, Shiraishi A, Fujino K, Sato Y, Ito T, Suzuki M. Long-Term Prognosis After Segmentectomy for cT1 N0 M0 Non-Small Cell Lung Cancer. Ann Thorac Surg. 2019 May;107(5):1500-1506. doi: 10.1016/j.athoracsur.2018.11.046. Epub 2018 Dec 21.
- Background: PubMed 31168591Stiles BM, Mao J, Harrison S, Lee B, Port JL, Altorki NK, Sedrakyan A. Sublobar resection for node-negative lung cancer 2-5 cm in size. Eur J Cardiothorac Surg. 2019 Nov 1;56(5):858-866. doi: 10.1093/ejcts/ezz146.
- Background: PubMed 24321996Bao F, Ye P, Yang Y, Wang L, Zhang C, Lv X, Hu J. Segmentectomy or lobectomy for early stage lung cancer: a meta-analysis. Eur J Cardiothorac Surg. 2014 Jul;46(1):1-7. doi: 10.1093/ejcts/ezt554. Epub 2013 Dec 8.
- Background: PubMed 27435809Shimizu K, Nagashima T, Ohtaki Y, Obayashi K, Nakazawa S, Kamiyoshihara M, Igai H, Takeyoshi I, Mogi A, Kuwano H. Analysis of the variation pattern in right upper pulmonary veins and establishment of simplified vein models for anatomical segmentectomy. Gen Thorac Cardiovasc Surg. 2016 Oct;64(10):604-11. doi: 10.1007/s11748-016-0686-4. Epub 2016 Jul 19.
- Background: PubMed 24158329Akiba T. Utility of three-dimensional computed tomography in general thoracic surgery. Gen Thorac Cardiovasc Surg. 2013 Dec;61(12):676-84. doi: 10.1007/s11748-013-0336-z. Epub 2013 Oct 25.
- 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.
ZARACA FRANCESCO principal investigator
Central Hospital Bolzano
Questions about this trial
What is this clinical trial studying?
A study testing CT scans 2D Reconstruction and CT scans 2D plus 3D Reconstruction in people with Lung Cancer and Lung; Node, run by Ospedale Centrale Bolzano.
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 4 inclusion and 5 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 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ZARACA Zaraca (+393334854703, francesco.zaraca@sabes.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversions from minimally invasive to thoracotomic procedure (time frame: Intraoperative). The study lists 2 primary outcomes in all. 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 NCT05716815, which also lists 20 linked publications.
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 29 Aug 2023.