Pulmonary MetastasesVATS-US1NCT03864874
Use of Thoracoscopic Intraoperative Lung Ultrasound to Identify Pulmonary Metastases in Patients Submitted to Pulmonary Metastasectomy With Radical Intent.
An observational study of Pulmonary Metastases, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.
Trial summary
Experience drawn from many scientific articles showed that many patients who develop a limited pattern of pulmonary metastases after treatment of a primary tumor may benefit from surgical resection of the lung deposits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Metastases
- What is being tested?
- Intraoperative intracavitary lung ultrasonography
- How many people
- 89 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 15 Jan 2022
- 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: Subjects with pulmonary oligometastases from various primary cancers.
Who may be able to join
- Patient candidate to pulmonary metastasectomy with curative intent by mean of both major anatomical or limited resection;
- Age > 18 years.
Who cannot join
- Patients with widespread metastatic disease where surgical resection is performed only for diagnostic purposes;
- History of previous intrapleural talc injection;
- Any anatomical or pathological condition (eg. diffuse adhesions, severe emphysema) that may interfere with execution of ultrasonographic investigation;
- Incomplete lung exclusion during surgical procedure.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Thoracic Surgery Unit, Cardiothoracic Dept., ASUI S Maria della Misericordia
Udine, Ud, 33100
francesco londero, 00390432554069, francesco.londero@asuiud.sanita.fvg.it
About this study
Official title: Thoracoscopic Ultrasonography Versus Manual Lung Palpation by Thoracotomy for the Identification of Lung Nodules During Pulmonary Metastasectomy. A Prospective Blinded Cross-over Trial.
Experience drawn from many scientific articles showed that many patients who develop a limited pattern of pulmonary metastases after treatment of a primary tumor may benefit from surgical resection of the lung deposits. Pulmonary metastasectomy with curative intent is widely performed with the aim of prolonging life and, in some cases, being curative. Usually the surgical strategy is defined based on analysis of radiological investigations, performed during a follow-up program after resection of a tumor. However, many studies showed that the actual sensitivity of this examinations, namely computed tomography (CT) and positron-emission tomography (PET) is far from being 100% and finding further unexpected nodules at operation with lung manual palpation is not uncommon. Many surgeons perform pulmonary metastasectomy with a minimally invasive approach, in view of a less morbid and more cosmetic approach, but lung palpation is considerably hampered and surgical radicality might be impaired. With this study the investigators want to assess the ability of lung ultrasonography performed via a key-hole access (thoracoscopy, VATS) in detecting lung nodules compared with the standard practice represented by open thoracotomy, that is a wider incision that allows manual exploration of the organ. Therefore, every patient enrolled will undergo a double phase surgical approach: a first phase by thoracoscopy where a thorough lung ultrasonography will be performed and number and position of lung nodules will be annotated, and a second phase by open thoracotomy where lung is palpated and suspicious nodules will be removed. The incisions used for the first phase will be extended for the second, rendering any other procedure for the execution of lung ultrasonography unnecessary.
Should this study demonstrate a non-inferiority of lung ultrasonography in detecting lung nodules compared with manual palpation of the lung, patients should be offered a less invasive approach for treatment of their condition with no concerns regarding a potential lower therapeutic effect.
Read the detailed description
Pulmonary metastasectomy is a surgical practice that poses many aspects of debate: standard approach has historically been represented by open thoracotomy, but video-assisted thoracic surgery (VATS) became an appealing alternative due to the lower surgical impact on the patient. Some authors blame the minimally invasive approach for pulmonary metastasectomy as less effective from an oncologic point of view since lung palpation is hampered, leading to reduced ability to identify unexpected nodules and potential impairment of surgical radicality.
Indeed, several papers demonstrated a suboptimal sensitivity of computed tomography (CT) and positron-emission tomography (PET) in detecting lung metastases and discover of further unexpected nodules at thoracotomy are not an uncommon eventuality.
A few authors demonstrated the utility of intraoperative lung ultrasound performed through a VATS approach (VATS-US) in identifying lung nodules. However, the real effectiveness of this technique has never been prospectively compared with the current gold standard represented by open thoracotomy and lung manual exploration. Aim of our study is to assess the non-inferiority of VATS-US compared with manual palpation to identify lung nodules during pulmonary metastasectomy.
The study design is a monocentric non-inferiority diagnostic crossover trial, based on the execution of intraoperative lung ultrasound (VATS-US) in patients undergoing pulmonary metastasectomy with radical intent. Aim of the study is to assess the non-inferiority of the ultrasonographic investigation on the lung parenchyma performed via a thoracoscopic approach in identifying lung nodules compared with manual organ palpation by thoracotomy.
Study design After general anesthesia administration patients will be intubated with a double lumen tube and positioned in a standard lateral decubitus. Thereby the target lung will be excluded from ventilation and deflated. After creation of 2-3 thoracoscopic ports the lung is explored under thoracoscopic vision with a laparoscopic ultrasound probe (Esaote LP323, Esaote, Genova, Italy) by a surgeon with experience on the use of lung ultrasound. Data regarding number, size, depth and lobar localization of nodules are registered on a data collection paper. The surgeon who performed the investigation therefore leaves the operative room and another surgeon, blind to the previous phase findings, performs an anterolateral thoracotomy and an accurate palpation of the lung. Suspicious nodules are therefore resected and sent for histology. Data on number and localization of excised nodules are registered on a separate collection paper. Results from both phases are then compared and matched with histology report.
Thoracotomy will be performed extending the length of the utility port. The others 1-2 hole are eventually used for insertion of chest drainage tubes, that in our institution are routinely positioned following any intervention within the pleural space. Consequently, no adjunctive incision will be performed for the execution of VATS-US compared with a standard thoracotomy approach. Only after nodules resection the two surgeons will compare their findings in order to make sure that any nodule identified at VATS-US but not at thoracotomy has not been omitted. The execution of the ultrasonographic investigation will require an appropriate lung deflation. Therefore, in some cases air aspiration from the target lung with a small catheter inserted through the endobronchial tube will be required, as previously described in other studies.
In order to guarantee patients' safety, they will never be left unattended during all phases of the intervention, and execution of any required urgent procedure for rare intraoperative complications will never be delayed, including those that may interfere with the execution of the ultrasonographic exam. It has been calculated that operative time will be extended of about 20-30 minutes to allow the execution of VATS-US.
No extra procedure or drugs administration will be required for the study. Only nodules that will be considered suspicious by the second surgeon during the thoracotomic phase or after discussion between the two operators will be excised, as expected in the standard practice.
The investigators will collect data regarding patients' features (age, biometric measurements, preoperative lung function tests data, lung comorbidities), preoperative CT scan findings (number, size and localization of lung nodules), ultrasonographic findings (number, size, depth, localization and shape of lung nodules), number and localization of nodules excised at thoracotomy, histology report data (histological nature, size, depth of lung nodules), time of surgery and of VATS-US, incidence of post-operative adverse events.
Sample size and statistical analysis Sensitivity and specificity of VATS-US will be calculated compared with manual palpation. The inter-rater agreement will be measured by calculating Cohen's kappa coefficient. Continuous data will be summarized as mean and standard deviation or median and twenty-fifth to seventy-fifth percentiles in case of non-normal distributions. Normality will be assessed by using Shapiro-Wilk test. Categorical variables will be reported as counts and percentages. Comparisons will be carried out using paired t-test, Wilcoxon signed ranks test and McNemar test where appropriate.
STATA software (release 14 StataCorp LP, College Station, TX, USA) will be utilized for analysis.
- Conditions
- Pulmonary Metastases
- Being tested
- Intraoperative intracavitary lung ultrasonography
- Keywords
- Pulmonary metastases, Intraoperative ultrasonography, Thoracoscopy, Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative intracavitary lung ultrasonographyDiagnostic test
Ultrasonography on the deflated lung for detection of lung nodules
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of nodules/lesions identified: surgery
Number of nodules identified at VATS-US and lung palpation/ number of lesions identified at lung palpation
Measured: Intraoperative
Number of nodules/lesions identified: histology
Number of nodules identified at VATS-US and lung palpation/ number of lesions confirmed to be pulmonary metastases
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion15 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pulmonary MetastasesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 89 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di Udine
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Principal investigator, Francesco Londero, Azienda Sanitaria-Universitaria Integrata di Udine
- Investigators
- Francesco Londero, MD, Principal investigator, Thoracic Surgery Unit, ASUI S Maria della Misericordia, UdineAngelo Morelli, MD, Study director, Thoracic Surgery Unit, ASUI S Maria della Misericordia, UdineSandro Gelsomino, MD, PhD, FESC, Study chair, Cardiothoracic Department Maastricht University Hospital, Maastricht, The NetherlandsLuigi Castriotta, MD, Study chair, Clinical Epidemiology Department, ASUI S Maria della Misericordia, UdineWilliam Grossi, MD, Study chair, Thoracic Surgery Unit, ASUI S Maria della Misericordia, UdineGianluca Masullo, MD, Study chair, Thoracic Surgery Unit, ASUI S Maria della Misericordia, Udine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864874
- Sponsor's protocol ID
- 30948
- Acronym
- VATS-US1
- Status last verified
- Jul 2020
- First submitted
- 22 Feb 2019
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Molnar TF, Gebitekin C, Turna A. What are the considerations in the surgical approach in pulmonary metastasectomy? J Thorac Oncol. 2010 Jun;5(6 Suppl 2):S140-4. doi: 10.1097/JTO.0b013e3181dcf62c.
PubMed 20502249Ellis MC, Hessman CJ, Weerasinghe R, Schipper PH, Vetto JT. Comparison of pulmonary nodule detection rates between preoperative CT imaging and intraoperative lung palpation. Am J Surg. 2011 May;201(5):619-22. doi: 10.1016/j.amjsurg.2011.01.005.
PubMed 21545910Eckardt J, Licht PB. Thoracoscopic or open surgery for pulmonary metastasectomy: an observer blinded study. Ann Thorac Surg. 2014 Aug;98(2):466-9; discussion 469-70. doi: 10.1016/j.athoracsur.2014.04.063. Epub 2014 Jun 11.
PubMed 24928676Macherey S, Doerr F, Heldwein M, Hekmat K. Is manual palpation of the lung necessary in patients undergoing pulmonary metastasectomy? Interact Cardiovasc Thorac Surg. 2016 Mar;22(3):351-9. doi: 10.1093/icvts/ivv337. Epub 2015 Dec 17.
PubMed 26678151Piolanti M, Coppola F, Papa S, Pilotti V, Mattioli S, Gavelli G. Ultrasonographic localization of occult pulmonary nodules during video-assisted thoracic surgery. Eur Radiol. 2003 Oct;13(10):2358-64. doi: 10.1007/s00330-003-1916-6. Epub 2003 May 8.
PubMed 12736756Rocco G, Cicalese M, La Manna C, La Rocca A, Martucci N, Salvi R. Ultrasonographic identification of peripheral pulmonary nodules through uniportal video-assisted thoracic surgery. Ann Thorac Surg. 2011 Sep;92(3):1099-101. doi: 10.1016/j.athoracsur.2011.03.030.
PubMed 21871306Mattioli S, D'Ovidio F, Daddi N, Ferruzzi L, Pilotti V, Ruffato A, Bolzani R, Gavelli G. Transthoracic endosonography for the intraoperative localization of lung nodules. Ann Thorac Surg. 2005 Feb;79(2):443-9; discussion 443-9. doi: 10.1016/j.athoracsur.2004.07.087.
PubMed 15680811Pastorino U, Buyse M, Friedel G, Ginsberg RJ, Girard P, Goldstraw P, Johnston M, McCormack P, Pass H, Putnam JB Jr; International Registry of Lung Metastases. Long-term results of lung metastasectomy: prognostic analyses based on 5206 cases. J Thorac Cardiovasc Surg. 1997 Jan;113(1):37-49. doi: 10.1016/s0022-5223(97)70397-0.
PubMed 9011700Vannucci F, Gonzalez-Rivas D. Is VATS lobectomy standard of care for operable non-small cell lung cancer? Lung Cancer. 2016 Oct;100:114-119. doi: 10.1016/j.lungcan.2016.08.004. Epub 2016 Aug 11.
PubMed 27597290Internullo E, Cassivi SD, Van Raemdonck D, Friedel G, Treasure T; ESTS Pulmonary Metastasectomy Working Group. Pulmonary metastasectomy: a survey of current practice amongst members of the European Society of Thoracic Surgeons. J Thorac Oncol. 2008 Nov;3(11):1257-66. doi: 10.1097/JTO.0b013e31818bd9da.
PubMed 18978560Lobo V, Weingrow D, Perera P, Williams SR, Gharahbaghian L. Thoracic ultrasonography. Crit Care Clin. 2014 Jan;30(1):93-117, v-vi. doi: 10.1016/j.ccc.2013.08.002.
PubMed 24295842Ujiie H, Kato T, Hu HP, Hasan S, Patel P, Wada H, Lee D, Fujino K, Hwang DM, Cypel M, de Perrot M, Pierre A, Darling G, Waddell TK, Keshavjee S, Yasufuku K. Evaluation of a New Ultrasound Thoracoscope for Localization of Lung Nodules in Ex Vivo Human Lungs. Ann Thorac Surg. 2017 Mar;103(3):926-934. doi: 10.1016/j.athoracsur.2016.08.031. Epub 2016 Oct 17.
PubMed 27765176Gossot D, Radu C, Girard P, Le Cesne A, Bonvalot S, Boudaya MS, Validire P, Magdeleinat P. Resection of pulmonary metastases from sarcoma: can some patients benefit from a less invasive approach? Ann Thorac Surg. 2009 Jan;87(1):238-43. doi: 10.1016/j.athoracsur.2008.09.036.
PubMed 19101304Londero F, Castriotta L, Grossi W, Masullo G, Morelli A, Tetta C, Livi U, Maessen JG, Gelsomino S. VATS-US1: Thoracoscopic ultrasonography for the identification of nodules during lung metastasectomy. Future Oncol. 2020 Feb;16(5):85-89. doi: 10.2217/fon-2019-0608. Epub 2020 Jan 9.
PubMed 31916464
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracoscopic Ultrasonography Versus Manual Lung Palpation by Thoracotomy for the Identification of Lung Nodules During Pulmonary Metastasectomy. A Prospective Blinded Cross-over Trial.
- ClinicalTrials.gov ID
- NCT03864874
- Acronym / sponsor ID
- VATS-US1 / 30948
- Conditions
- Pulmonary Metastases
- Keywords
- Pulmonary metastases, Intraoperative ultrasonography, Thoracoscopy, Lung
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di UdineUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 15 Jan 2022 (estimated)
- First posted
- 6 Mar 2019 (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.
Experience drawn from many scientific articles showed that many patients who develop a limited pattern of pulmonary metastases after treatment of a primary tumor may benefit from surgical resection of the lung deposits. Pulmonary metastasectomy with curative intent is widely performed with the aim of prolonging life and, in some cases, being curative. Usually the surgical strategy is defined based on analysis of radiological investigations, performed during a follow-up program after resection of a tumor. However, many studies showed that the actual sensitivity of this examinations, namely computed tomography (CT) and positron-emission tomography (PET) is far from being 100% and finding further unexpected nodules at operation with lung manual palpation is not uncommon. Many surgeons perform pulmonary metastasectomy with a minimally invasive approach, in view of a less morbid and more cosmetic approach, but lung palpation is considerably hampered and surgical radicality might be impaired. With this study the investigators want to assess the ability of lung ultrasonography performed via a key-hole access (thoracoscopy, VATS) in detecting lung nodules compared with the standard practice represented by open thoracotomy, that is a wider incision that allows manual exploration of the organ. Therefore, every patient enrolled will undergo a double phase surgical approach: a first phase by thoracoscopy where a thorough lung ultrasonography will be performed and number and position of lung nodules will be annotated, and a second phase by open thoracotomy where lung is palpated and suspicious nodules will be removed. The incisions used for the first phase will be extended for the second, rendering any other procedure for the execution of lung ultrasonography unnecessary.
Should this study demonstrate a non-inferiority of lung ultrasonography in detecting lung nodules compared with manual palpation of the lung, patients should be offered a less invasive approach for treatment of their condition with no concerns regarding a potential lower therapeutic effect.
Detailed description
Pulmonary metastasectomy is a surgical practice that poses many aspects of debate: standard approach has historically been represented by open thoracotomy, but video-assisted thoracic surgery (VATS) became an appealing alternative due to the lower surgical impact on the patient. Some authors blame the minimally invasive approach for pulmonary metastasectomy as less effective from an oncologic point of view since lung palpation is hampered, leading to reduced ability to identify unexpected nodules and potential impairment of surgical radicality.
Indeed, several papers demonstrated a suboptimal sensitivity of computed tomography (CT) and positron-emission tomography (PET) in detecting lung metastases and discover of further unexpected nodules at thoracotomy are not an uncommon eventuality.
A few authors demonstrated the utility of intraoperative lung ultrasound performed through a VATS approach (VATS-US) in identifying lung nodules. However, the real effectiveness of this technique has never been prospectively compared with the current gold standard represented by open thoracotomy and lung manual exploration. Aim of our study is to assess the non-inferiority of VATS-US compared with manual palpation to identify lung nodules during pulmonary metastasectomy.
The study design is a monocentric non-inferiority diagnostic crossover trial, based on the execution of intraoperative lung ultrasound (VATS-US) in patients undergoing pulmonary metastasectomy with radical intent. Aim of the study is to assess the non-inferiority of the ultrasonographic investigation on the lung parenchyma performed via a thoracoscopic approach in identifying lung nodules compared with manual organ palpation by thoracotomy.
Study design After general anesthesia administration patients will be intubated with a double lumen tube and positioned in a standard lateral decubitus. Thereby the target lung will be excluded from ventilation and deflated. After creation of 2-3 thoracoscopic ports the lung is explored under thoracoscopic vision with a laparoscopic ultrasound probe (Esaote LP323, Esaote, Genova, Italy) by a surgeon with experience on the use of lung ultrasound. Data regarding number, size, depth and lobar localization of nodules are registered on a data collection paper. The surgeon who performed the investigation therefore leaves the operative room and another surgeon, blind to the previous phase findings, performs an anterolateral thoracotomy and an accurate palpation of the lung. Suspicious nodules are therefore resected and sent for histology. Data on number and localization of excised nodules are registered on a separate collection paper. Results from both phases are then compared and matched with histology report.
Thoracotomy will be performed extending the length of the utility port. The others 1-2 hole are eventually used for insertion of chest drainage tubes, that in our institution are routinely positioned following any intervention within the pleural space. Consequently, no adjunctive incision will be performed for the execution of VATS-US compared with a standard thoracotomy approach. Only after nodules resection the two surgeons will compare their findings in order to make sure that any nodule identified at VATS-US but not at thoracotomy has not been omitted. The execution of the ultrasonographic investigation will require an appropriate lung deflation. Therefore, in some cases air aspiration from the target lung with a small catheter inserted through the endobronchial tube will be required, as previously described in other studies.
In order to guarantee patients' safety, they will never be left unattended during all phases of the intervention, and execution of any required urgent procedure for rare intraoperative complications will never be delayed, including those that may interfere with the execution of the ultrasonographic exam. It has been calculated that operative time will be extended of about 20-30 minutes to allow the execution of VATS-US.
No extra procedure or drugs administration will be required for the study. Only nodules that will be considered suspicious by the second surgeon during the thoracotomic phase or after discussion between the two operators will be excised, as expected in the standard practice.
The investigators will collect data regarding patients' features (age, biometric measurements, preoperative lung function tests data, lung comorbidities), preoperative CT scan findings (number, size and localization of lung nodules), ultrasonographic findings (number, size, depth, localization and shape of lung nodules), number and localization of nodules excised at thoracotomy, histology report data (histological nature, size, depth of lung nodules), time of surgery and of VATS-US, incidence of post-operative adverse events.
Sample size and statistical analysis Sensitivity and specificity of VATS-US will be calculated compared with manual palpation. The inter-rater agreement will be measured by calculating Cohen's kappa coefficient. Continuous data will be summarized as mean and standard deviation or median and twenty-fifth to seventy-fifth percentiles in case of non-normal distributions. Normality will be assessed by using Shapiro-Wilk test. Categorical variables will be reported as counts and percentages. Comparisons will be carried out using paired t-test, Wilcoxon signed ranks test and McNemar test where appropriate.
STATA software (release 14 StataCorp LP, College Station, TX, USA) will be utilized for analysis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with pulmonary oligometastases from various primary cancers.
Key inclusion criteria (2 listed)
- Patient candidate to pulmonary metastasectomy with curative intent by mean of both major anatomical or limited resection;
- Age > 18 years.
Key exclusion criteria (4 listed)
- Patients with widespread metastatic disease where surgical resection is performed only for diagnostic purposes;
- History of previous intrapleural talc injection;
- Any anatomical or pathological condition (eg. diffuse adhesions, severe emphysema) that may interfere with execution of ultrasonographic investigation;
- Incomplete lung exclusion during surgical procedure.
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 |
|---|---|---|
| Intraoperative intracavitary lung ultrasonographyUltrasonography on the deflated lung for detection of lung nodules | Diagnostic test | – |
Primary outcome
Number of nodules/lesions identified: surgery
Time frame: Intraoperative
Number of nodules identified at VATS-US and lung palpation/ number of lesions identified at lung palpation
Number of nodules/lesions identified: histology
Time frame: Up to 2 weeks
Number of nodules identified at VATS-US and lung palpation/ number of lesions confirmed to be pulmonary metastases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Background: PubMed 20502249Molnar TF, Gebitekin C, Turna A. What are the considerations in the surgical approach in pulmonary metastasectomy? J Thorac Oncol. 2010 Jun;5(6 Suppl 2):S140-4. doi: 10.1097/JTO.0b013e3181dcf62c.
- Background: PubMed 21545910Ellis MC, Hessman CJ, Weerasinghe R, Schipper PH, Vetto JT. Comparison of pulmonary nodule detection rates between preoperative CT imaging and intraoperative lung palpation. Am J Surg. 2011 May;201(5):619-22. doi: 10.1016/j.amjsurg.2011.01.005.
- Background: PubMed 24928676Eckardt J, Licht PB. Thoracoscopic or open surgery for pulmonary metastasectomy: an observer blinded study. Ann Thorac Surg. 2014 Aug;98(2):466-9; discussion 469-70. doi: 10.1016/j.athoracsur.2014.04.063. Epub 2014 Jun 11.
- Background: PubMed 26678151Macherey S, Doerr F, Heldwein M, Hekmat K. Is manual palpation of the lung necessary in patients undergoing pulmonary metastasectomy? Interact Cardiovasc Thorac Surg. 2016 Mar;22(3):351-9. doi: 10.1093/icvts/ivv337. Epub 2015 Dec 17.
- Background: PubMed 12736756Piolanti M, Coppola F, Papa S, Pilotti V, Mattioli S, Gavelli G. Ultrasonographic localization of occult pulmonary nodules during video-assisted thoracic surgery. Eur Radiol. 2003 Oct;13(10):2358-64. doi: 10.1007/s00330-003-1916-6. Epub 2003 May 8.
- Background: PubMed 21871306Rocco G, Cicalese M, La Manna C, La Rocca A, Martucci N, Salvi R. Ultrasonographic identification of peripheral pulmonary nodules through uniportal video-assisted thoracic surgery. Ann Thorac Surg. 2011 Sep;92(3):1099-101. doi: 10.1016/j.athoracsur.2011.03.030.
- Background: PubMed 15680811Mattioli S, D'Ovidio F, Daddi N, Ferruzzi L, Pilotti V, Ruffato A, Bolzani R, Gavelli G. Transthoracic endosonography for the intraoperative localization of lung nodules. Ann Thorac Surg. 2005 Feb;79(2):443-9; discussion 443-9. doi: 10.1016/j.athoracsur.2004.07.087.
- Background: PubMed 9011700Pastorino U, Buyse M, Friedel G, Ginsberg RJ, Girard P, Goldstraw P, Johnston M, McCormack P, Pass H, Putnam JB Jr; International Registry of Lung Metastases. Long-term results of lung metastasectomy: prognostic analyses based on 5206 cases. J Thorac Cardiovasc Surg. 1997 Jan;113(1):37-49. doi: 10.1016/s0022-5223(97)70397-0.
- Background: PubMed 27597290Vannucci F, Gonzalez-Rivas D. Is VATS lobectomy standard of care for operable non-small cell lung cancer? Lung Cancer. 2016 Oct;100:114-119. doi: 10.1016/j.lungcan.2016.08.004. Epub 2016 Aug 11.
- Background: PubMed 18978560Internullo E, Cassivi SD, Van Raemdonck D, Friedel G, Treasure T; ESTS Pulmonary Metastasectomy Working Group. Pulmonary metastasectomy: a survey of current practice amongst members of the European Society of Thoracic Surgeons. J Thorac Oncol. 2008 Nov;3(11):1257-66. doi: 10.1097/JTO.0b013e31818bd9da.
- Background: PubMed 24295842Lobo V, Weingrow D, Perera P, Williams SR, Gharahbaghian L. Thoracic ultrasonography. Crit Care Clin. 2014 Jan;30(1):93-117, v-vi. doi: 10.1016/j.ccc.2013.08.002.
- Background: PubMed 27765176Ujiie H, Kato T, Hu HP, Hasan S, Patel P, Wada H, Lee D, Fujino K, Hwang DM, Cypel M, de Perrot M, Pierre A, Darling G, Waddell TK, Keshavjee S, Yasufuku K. Evaluation of a New Ultrasound Thoracoscope for Localization of Lung Nodules in Ex Vivo Human Lungs. Ann Thorac Surg. 2017 Mar;103(3):926-934. doi: 10.1016/j.athoracsur.2016.08.031. Epub 2016 Oct 17.
- Individual participant dataSharing planned: Undecided
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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.
Francesco Londero, MD principal investigator
Thoracic Surgery Unit, ASUI S Maria della Misericordia, Udine
Angelo Morelli, MD study director
Thoracic Surgery Unit, ASUI S Maria della Misericordia, Udine
Sandro Gelsomino, MD, PhD, FESC study chair
Cardiothoracic Department Maastricht University Hospital, Maastricht, The Netherlands
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 Pulmonary Metastases, run by Azienda Sanitaria-Universitaria Integrata di Udine 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 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: status not confirmed, as of the sponsor's last update on 8 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact francesco londero, MD (+390432554069, francesco.londero@asuiud.sanita.fvg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of nodules/lesions identified: surgery (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 NCT03864874, which also lists 14 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 8 Jul 2020.