Use of Thoracoscopic Intraoperative Lung Ultrasound to Identify Pulmonary Metastases in Patients Submitted to Pulmonary Metastasectomy With Radical Intent.

NCT03864874 | Unknown

• 1 other identifier: 30948
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pulmonary Metastases

Keywords

Pulmonary metastases; Intraoperative ultrasonography; Thoracoscopy; Lung

Outcome Measures

Primary Outcomes (2)

• Number of nodules/lesions identified: surgery

  Number of nodules identified at VATS-US and lung palpation/ number of lesions identified at lung palpation

  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

  Up to 2 weeks

Interventions

Intraoperative intracavitary lung ultrasonography DIAGNOSTIC_TEST

Ultrasonography on the deflated lung for detection of lung nodules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with pulmonary oligometastases from various primary cancers.

You may qualify if:

• Patient candidate to pulmonary metastasectomy with curative intent by mean of both major anatomical or limited resection;
• Age \> 18 years.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Azienda Sanitaria-Universitaria Integrata di Udine: lead
• Maastricht University: collaborator

Study Sites (1)

Thoracic Surgery Unit, Cardiothoracic Dept., ASUI S Maria della Misericordia

Udine, Ud, 33100, Italy

RECRUITING

Related Publications (14)

• 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.

  PMID: 20502249 BACKGROUND

• Ellis 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.

  PMID: 21545910 BACKGROUND

• Eckardt 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.

  PMID: 24928676 BACKGROUND

• Macherey 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.

  PMID: 26678151 BACKGROUND

• Piolanti 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.

  PMID: 12736756 BACKGROUND

• Rocco 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.

  PMID: 21871306 BACKGROUND

• Mattioli 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.

  PMID: 15680811 BACKGROUND

• Pastorino 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.

  PMID: 9011700 BACKGROUND

• Vannucci 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.

  PMID: 27597290 BACKGROUND

• Internullo 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.

  PMID: 18978560 BACKGROUND

• Lobo 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.

  PMID: 24295842 BACKGROUND

• Ujiie 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.

  PMID: 27765176 BACKGROUND

• Gossot 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.

  PMID: 19101304 BACKGROUND

• Londero 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.

  PMID: 31916464 DERIVED

Study Officials

• Francesco Londero, MD

  Thoracic Surgery Unit, ASUI S Maria della Misericordia, Udine

  PRINCIPAL INVESTIGATOR

• Angelo Morelli, MD

  Thoracic Surgery Unit, ASUI S Maria della Misericordia, Udine

  STUDY DIRECTOR

• Sandro Gelsomino, MD, PhD, FESC

  Cardiothoracic Department Maastricht University Hospital, Maastricht, The Netherlands

  STUDY CHAIR

• Luigi Castriotta, MD

  Clinical Epidemiology Department, ASUI S Maria della Misericordia, Udine

  STUDY CHAIR

• William Grossi, MD

  Thoracic Surgery Unit, ASUI S Maria della Misericordia, Udine

  STUDY CHAIR

• Gianluca Masullo, MD

  Thoracic Surgery Unit, ASUI S Maria della Misericordia, Udine

  STUDY CHAIR

Central Study Contacts

francesco londero, MD

CONTACT

+390432554069; francesco.londero@asuiud.sanita.fvg.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: March 6, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: January 15, 2022
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

IT (1)