Thoracic SurgeryNCT04048512
Circulating Tumor Cells (CTC) Before and After Thoracic Resection With and Without Intraoperative Use of ExtraCorporeal Membrane Oxygenator(ECMO) or Cardio Pulmonary By Pass (CPB)
An observational study of Thoracic Surgery and Cardiopulmonary Bypass, run by European Institute of Oncology at 1 site in Italy.
Trial summary
The role of circulating tumor cells (CTC) in patients suffering from lung cancer and thoracic malignancies is not well known and it is still widely debated. The use of intraoperative cardiorespiratory supports like ECMO (extracorporeal membrane oxygenator) and CPB (cardiopulmonary by-pass) during extended resections… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Cardiopulmonary Bypass
- What is being tested?
- Resection with intraoperative use of ECMO/CPB and Resection without intraoperative use of ECMO/CPB
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 22 Aug 2019to 30 Oct 2023
- 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: Ten consecutive patients with planned intraoperative cardiorespiratory support will be enrolled and blood samples will be collected to search for CTC. The patients will then undergo operation with Extra Corporeal membarne Oxygenator (ECMO) or Cardio Pulmonary By Pass (CPB) support. After the procedure peripheral blood samples will be collected as previously reported to search for Circulating Tumor Cells (CTC). Ten consecutive patients, presenting the same neoplastic diseases of the experimental arm and with same extension but not requiring intraoperative ECMO or CPB support will be enrolled in the control arm, receiving the same blood sample collection before and after surgery, to assess the presence and the amount of CTC. The two groups will be than compared in terms of preoperative and postoperative CTC presence and amount.
Who may be able to join
- Thoracic resection (lung and or mediastinal resection) requiring intraoperative Extra Coprporeal Membrane Oxygenator (ECMO) or Cardio Pulmonary By pass (CPB) support; in the control group same disease and planned procedure to be performed without the need of EMCO or CPB.
- Infiltration of the main carina
- Infiltration of superior vena cava
- Single lung surgery
- Mediastinal involvment
Who cannot join
- Age younger than 18 years
- Contraindications to general anesthesia
- Poor general clinical conditions ( ECOG PS >=2)
- Patients unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
European Institue of Oncology
Milan, 20143
Francesco Petrella, MD, Ph D, 00390294372921, francesco.petrella@ieo.it
About this study
Official title: Circulating Tumor Cells (CTC) Before and After Thoracic Resection With and Without Intraoperative Use of Extra Coprporeal Membrane Oxygenator (ECMO) or Cardio Pulmonary By Pass (CPB)
The role of circulating tumor cells (CTC) in patients suffering from lung cancer and thoracic malignancies is not well known and it is still widely debated. The use of intraoperative cardiorespiratory supports like ECMO (extracorporeal membrane oxygenator) and CPB (cardiopulmonary by-pass) during extended resections in oncologic patients has been questioned because of the theoretical risk of tumor cells spreading, although there is no clinical or experimental evidence supporting this hypothesis.
The aim of the present study is to quantify the possible presence and amount of CTC in the peripheral blood of patients undergoing lung/mediastinal resection, before and after surgical procedure, comparing patients receiving intraoperative cardiorespiratory support with patients - with similar oncologic disease and extension - operated without the need of ECMO or CPB.
Read the detailed description
Background and Rationale:
Locally advanced pulmonary and mediastinal cancers invading vital structure such as heart, great vessels, or carina cancer are generally considered as unresectable and incurable. Complete resection in healthy tissue may be compromised due to the proximity of the tumors to vital organs [1, 2]. Palliation with chemotherapy and/or radiotherapy is the principal means of treatment [1, 2]. In highly selected patients with specific anatomic conditions, complete R0 resection for locally advanced tumor has been reported with prolonged survival and, on occasion, resulted in cure [3-5]. Complex cardiac resections or reconstructions, replacement of the thoracic aorta, or the common pulmonary artery can only be approached with cardiac arrest and total circulatory support by standard cardio-pulmonary bypass (CPB) [6,7]; extracorporeal membrane oxygenation (ECMO) is a well- established technique for the management of respiratory or hemodynamic disturbance during lung transplantation. Technological advances in pumps, cannulae, and oxygenators and growing experience for thoracic surgeon during lung transplantation have led to the use of ECMO during conventional thoracic surgical procedure [8,9].
A theoretical possibility of enhancement of metastasis due to ECMO or CPB has been reported [10] although no clear evidence exists ; nevertheless, due to the lack of data about this aspect, many cardio-thoracic surgeons are skeptical about the use of intraoperative CPB or ECMO .
The aim of this protocol is to assess the presence or not and possibly the amount of CTC before and after surgery in the peripheral blood of patients undergoing thoracic resection with (experimental arm) or without (control arm) intraoperative support of ECMO or CPB.
Study design and duration Prospective, double arm , observational study.
Ten consecutive patients - with thoracic malignancies undergoing resection with planned intraoperative cardiorespiratory support - will be enrolled. Before surgery peripheral blood samples will be collected (as subsequently described) to search the presence and the amount of CTC. The patients will then undergo surgical procedure with intraoperative ECMO or CPB support. After the procedure peripheral blood samples will be collected as previously reported to search for CTC.
Ten consecutive patients, presenting the same neoplastic diseases of the experimental arm and with same extension but not requiring intraoperative ECMO or CPB support will be enrolled in the control arm, receiving the same blood sample collection before and after surgery, to assess the presence and the amount of CTC.
The two groups will be than compared in terms of preoperative and postoperative CTC presence and amount.
- Conditions
- Thoracic Surgery, Cardiopulmonary Bypass
- Being tested
- Resection with intraoperative use of ECMO/CPB, Resection without intraoperative use of ECMO/CPB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resection with intraoperative use of ECMO/CPBProcedure or surgery
Patients are operated with the use of intraoperative ECMO/CPB
Resection without intraoperative use of ECMO/CPBProcedure or surgery
Patients are operated without the use of intraoperative ECMO/CPB
| Study group | Role | What they receive |
|---|---|---|
| Resection with intraoperative ECMO/CPB | Patients suffering of neoplastic thoracic disease, undergoing thoracic resection with intraoperative use of Extra Corporeal Membrane Oxygenator (ECMO) or Cardio Pulmonary By pass (CPB) Receives: Procedure: Resection with intraoperative use of ECMO/CPB | |
| Resection without intraoperative ECMO/CPB | Patients suffering of neoplastic thoracic disease, undergoing thoracic resection without intraoperative use of Extra Corporeal Membrane Oxygenator (ECMO) or Cardio pulmonary By Pass (CPB) Receives: Procedure: Resection without intraoperative use of ECMO/CPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the number of circulating tumor cells the day before surgery and first post operative day (24 hours after surgery)
Quantification of CTC (number) in peripheral blood
Measured: The day before surgery and the first post operative day (24 hours after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start22 Aug 2019
- Primary completion22 Jul 2021
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Thoracic SurgeryStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Petrella, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048512
- Sponsor's protocol ID
- R1005/19-IEO 1060
- Status last verified
- Jun 2023
- First submitted
- 2 Aug 2019
- Last updated
- 28 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spira A, Ettinger DS. Multidisciplinary management of lung cancer. N Engl J Med. 2004 Jan 22;350(4):379-92. doi: 10.1056/NEJMra035536. No abstract available.
PubMed 14736930Rice TW, Blackstone EH. Radical resections for T4 lung cancer. Surg Clin North Am. 2002 Jun;82(3):573-87. doi: 10.1016/s0039-6109(02)00017-8.
PubMed 12371586Regnard JF, Perrotin C, Giovannetti R, Schussler O, Petino A, Spaggiari L, Alifano M, Magdeleinat P. Resection for tumors with carinal involvement: technical aspects, results, and prognostic factors. Ann Thorac Surg. 2005 Nov;80(5):1841-6. doi: 10.1016/j.athoracsur.2005.04.032.
PubMed 16242466de Perrot M, Fadel E, Mercier O, Mussot S, Chapelier A, Dartevelle P. Long-term results after carinal resection for carcinoma: does the benefit warrant the risk? J Thorac Cardiovasc Surg. 2006 Jan;131(1):81-9. doi: 10.1016/j.jtcvs.2005.07.062. Epub 2005 Dec 5.
PubMed 16399298Perentes J, Bopp S, Krueger T, Gonzalez M, Jayet PY, Lovis A, Matzinger O, Ruffieux C, Ris HB, Letovanec I, Peters S. Impact of lung function changes after induction radiochemotherapy on resected T4 non-small cell lung cancer outcome. Ann Thorac Surg. 2012 Dec;94(6):1815-22. doi: 10.1016/j.athoracsur.2012.08.054. Epub 2012 Oct 25.
PubMed 23103000Tsuchiya R, Asamura H, Kondo H, Goya T, Naruke T. Extended resection of the left atrium, great vessels, or both for lung cancer. Ann Thorac Surg. 1994 Apr;57(4):960-5. doi: 10.1016/0003-4975(94)90214-3.
PubMed 8166550Rao V, Todd TR, Weisel RD, Komeda M, Cohen G, Ikonomidis JS, Christakis GT. Results of combined pulmonary resection and cardiac operation. Ann Thorac Surg. 1996 Aug;62(2):342-6; discussion 346-7.
PubMed 8694588Lang G, Ghanim B, Hotzenecker K, Klikovits T, Matilla JR, Aigner C, Taghavi S, Klepetko W. Extracorporeal membrane oxygenation support for complex tracheo-bronchial proceduresdagger. Eur J Cardiothorac Surg. 2015 Feb;47(2):250-5; discussion 256. doi: 10.1093/ejcts/ezu162. Epub 2014 Apr 16.
PubMed 24740936Lang G, Taghavi S, Aigner C, Charchian R, Matilla JR, Sano A, Klepetko W. Extracorporeal membrane oxygenation support for resection of locally advanced thoracic tumors. Ann Thorac Surg. 2011 Jul;92(1):264-70. doi: 10.1016/j.athoracsur.2011.04.001.
PubMed 21718853Brutel de la Riviere A, Knaepen P, Van Swieten H, Vanderschueren R, Ernst J, Van den Bosch J. Concomitant open heart surgery and pulmonary resection for lung cancer. Eur J Cardiothorac Surg. 1995;9(6):310-3; discussion 313-4. doi: 10.1016/s1010-7940(05)80188-5.
PubMed 7546803
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor Cells (CTC) Before and After Thoracic Resection With and Without Intraoperative Use of Extra Coprporeal Membrane Oxygenator (ECMO) or Cardio Pulmonary By Pass (CPB)
- ClinicalTrials.gov ID
- NCT04048512
- Acronym / sponsor ID
- R1005/19-IEO 1060
- Conditions
- Thoracic Surgery, Cardiopulmonary Bypass
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 22 Jul 2021 (actual)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 7 Aug 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.
The role of circulating tumor cells (CTC) in patients suffering from lung cancer and thoracic malignancies is not well known and it is still widely debated. The use of intraoperative cardiorespiratory supports like ECMO (extracorporeal membrane oxygenator) and CPB (cardiopulmonary by-pass) during extended resections in oncologic patients has been questioned because of the theoretical risk of tumor cells spreading, although there is no clinical or experimental evidence supporting this hypothesis.
The aim of the present study is to quantify the possible presence and amount of CTC in the peripheral blood of patients undergoing lung/mediastinal resection, before and after surgical procedure, comparing patients receiving intraoperative cardiorespiratory support with patients - with similar oncologic disease and extension - operated without the need of ECMO or CPB.
Detailed description
Background and Rationale:
Locally advanced pulmonary and mediastinal cancers invading vital structure such as heart, great vessels, or carina cancer are generally considered as unresectable and incurable. Complete resection in healthy tissue may be compromised due to the proximity of the tumors to vital organs [1, 2]. Palliation with chemotherapy and/or radiotherapy is the principal means of treatment [1, 2]. In highly selected patients with specific anatomic conditions, complete R0 resection for locally advanced tumor has been reported with prolonged survival and, on occasion, resulted in cure [3-5]. Complex cardiac resections or reconstructions, replacement of the thoracic aorta, or the common pulmonary artery can only be approached with cardiac arrest and total circulatory support by standard cardio-pulmonary bypass (CPB) [6,7]; extracorporeal membrane oxygenation (ECMO) is a well- established technique for the management of respiratory or hemodynamic disturbance during lung transplantation. Technological advances in pumps, cannulae, and oxygenators and growing experience for thoracic surgeon during lung transplantation have led to the use of ECMO during conventional thoracic surgical procedure [8,9].
A theoretical possibility of enhancement of metastasis due to ECMO or CPB has been reported [10] although no clear evidence exists ; nevertheless, due to the lack of data about this aspect, many cardio-thoracic surgeons are skeptical about the use of intraoperative CPB or ECMO .
The aim of this protocol is to assess the presence or not and possibly the amount of CTC before and after surgery in the peripheral blood of patients undergoing thoracic resection with (experimental arm) or without (control arm) intraoperative support of ECMO or CPB.
Study design and duration Prospective, double arm , observational study.
Ten consecutive patients - with thoracic malignancies undergoing resection with planned intraoperative cardiorespiratory support - will be enrolled. Before surgery peripheral blood samples will be collected (as subsequently described) to search the presence and the amount of CTC. The patients will then undergo surgical procedure with intraoperative ECMO or CPB support. After the procedure peripheral blood samples will be collected as previously reported to search for CTC.
Ten consecutive patients, presenting the same neoplastic diseases of the experimental arm and with same extension but not requiring intraoperative ECMO or CPB support will be enrolled in the control arm, receiving the same blood sample collection before and after surgery, to assess the presence and the amount of CTC.
The two groups will be than compared in terms of preoperative and postoperative CTC presence and amount.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resection with intraoperative ECMO/CPB | – | Procedure: Resection with intraoperative use of ECMO/CPBPatients suffering of neoplastic thoracic disease, undergoing thoracic resection with intraoperative use of Extra Corporeal Membrane Oxygenator (ECMO) or Cardio Pulmonary By pass (CPB) |
| Resection without intraoperative ECMO/CPB | – | Procedure: Resection without intraoperative use of ECMO/CPBPatients suffering of neoplastic thoracic disease, undergoing thoracic resection without intraoperative use of Extra Corporeal Membrane Oxygenator (ECMO) or Cardio pulmonary By Pass (CPB) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ten consecutive patients with planned intraoperative cardiorespiratory support will be enrolled and blood samples will be collected to search for CTC. The patients will then undergo operation with Extra Corporeal membarne Oxygenator (ECMO) or Cardio Pulmonary By Pass (CPB) support. After the procedure peripheral blood samples will be collected as previously reported to search for Circulating Tumor Cells (CTC). Ten consecutive patients, presenting the same neoplastic diseases of the experimental arm and with same extension but not requiring intraoperative ECMO or CPB support will be enrolled in the control arm, receiving the same blood sample collection before and after surgery, to assess the presence and the amount of CTC. The two groups will be than compared in terms of preoperative and postoperative CTC presence and amount.
Key inclusion criteria (5 listed)
- Thoracic resection (lung and or mediastinal resection) requiring intraoperative Extra Coprporeal Membrane Oxygenator (ECMO) or Cardio Pulmonary By pass (CPB) support; in the control group same disease and planned procedure to be performed without the need of EMCO or CPB.
- Infiltration of the main carina
- Infiltration of superior vena cava
- Single lung surgery
- Mediastinal involvment
Key exclusion criteria (4 listed)
- Age younger than 18 years
- Contraindications to general anesthesia
- Poor general clinical conditions ( ECOG PS >=2)
- Patients unable to provide informed consent
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 |
|---|---|---|
| Resection with intraoperative use of ECMO/CPBPatients are operated with the use of intraoperative ECMO/CPB | Procedure or surgery | Resection with intraoperative ECMO/CPB |
| Resection without intraoperative use of ECMO/CPBPatients are operated without the use of intraoperative ECMO/CPB | Procedure or surgery | Resection without intraoperative ECMO/CPB |
Primary outcome
Assessment of the number of circulating tumor cells the day before surgery and first post operative day (24 hours after surgery)
Time frame: The day before surgery and the first post operative day (24 hours after surgery)
Quantification of CTC (number) in peripheral blood
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Background: PubMed 14736930Spira A, Ettinger DS. Multidisciplinary management of lung cancer. N Engl J Med. 2004 Jan 22;350(4):379-92. doi: 10.1056/NEJMra035536. No abstract available.
- Background: PubMed 12371586Rice TW, Blackstone EH. Radical resections for T4 lung cancer. Surg Clin North Am. 2002 Jun;82(3):573-87. doi: 10.1016/s0039-6109(02)00017-8.
- Background: PubMed 16242466Regnard JF, Perrotin C, Giovannetti R, Schussler O, Petino A, Spaggiari L, Alifano M, Magdeleinat P. Resection for tumors with carinal involvement: technical aspects, results, and prognostic factors. Ann Thorac Surg. 2005 Nov;80(5):1841-6. doi: 10.1016/j.athoracsur.2005.04.032.
- Background: PubMed 16399298de Perrot M, Fadel E, Mercier O, Mussot S, Chapelier A, Dartevelle P. Long-term results after carinal resection for carcinoma: does the benefit warrant the risk? J Thorac Cardiovasc Surg. 2006 Jan;131(1):81-9. doi: 10.1016/j.jtcvs.2005.07.062. Epub 2005 Dec 5.
- Background: PubMed 23103000Perentes J, Bopp S, Krueger T, Gonzalez M, Jayet PY, Lovis A, Matzinger O, Ruffieux C, Ris HB, Letovanec I, Peters S. Impact of lung function changes after induction radiochemotherapy on resected T4 non-small cell lung cancer outcome. Ann Thorac Surg. 2012 Dec;94(6):1815-22. doi: 10.1016/j.athoracsur.2012.08.054. Epub 2012 Oct 25.
- Background: PubMed 8166550Tsuchiya R, Asamura H, Kondo H, Goya T, Naruke T. Extended resection of the left atrium, great vessels, or both for lung cancer. Ann Thorac Surg. 1994 Apr;57(4):960-5. doi: 10.1016/0003-4975(94)90214-3.
- Background: PubMed 8694588Rao V, Todd TR, Weisel RD, Komeda M, Cohen G, Ikonomidis JS, Christakis GT. Results of combined pulmonary resection and cardiac operation. Ann Thorac Surg. 1996 Aug;62(2):342-6; discussion 346-7.
- Background: PubMed 24740936Lang G, Ghanim B, Hotzenecker K, Klikovits T, Matilla JR, Aigner C, Taghavi S, Klepetko W. Extracorporeal membrane oxygenation support for complex tracheo-bronchial proceduresdagger. Eur J Cardiothorac Surg. 2015 Feb;47(2):250-5; discussion 256. doi: 10.1093/ejcts/ezu162. Epub 2014 Apr 16.
- Background: PubMed 21718853Lang G, Taghavi S, Aigner C, Charchian R, Matilla JR, Sano A, Klepetko W. Extracorporeal membrane oxygenation support for resection of locally advanced thoracic tumors. Ann Thorac Surg. 2011 Jul;92(1):264-70. doi: 10.1016/j.athoracsur.2011.04.001.
- Background: PubMed 7546803Brutel de la Riviere A, Knaepen P, Van Swieten H, Vanderschueren R, Ernst J, Van den Bosch J. Concomitant open heart surgery and pulmonary resection for lung cancer. Eur J Cardiothorac Surg. 1995;9(6):310-3; discussion 313-4. doi: 10.1016/s1010-7940(05)80188-5.
- 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.
Francesco Petrella principal investigator
European Institute of Oncology
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 Thoracic Surgery and Cardiopulmonary Bypass, run by European Institute of Oncology 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 5 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 28 Jun 2023. 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 Petrella, MD, PhD (00393388231311, francesco.petrella@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the number of circulating tumor cells the day before surgery and first post operative day (24 hours after surgery) (time frame: The day before surgery and the first post operative day (24 hours 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 NCT04048512, which also lists 10 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 28 Jun 2023.