Lung CancerNCT05904574
Effectiveness of the Autologous Blood Patch Method in Lung Biopsies
An observational study of Lung Cancer and Pneumothorax, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
In this retrospective study, investigators aimed to evaluate the effectiveness of the autologous blood patch method in percutaneous transthoracic lung biopsies performed with the coaxial technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Pneumothorax
- What is being tested?
- Autologous blood patch and Percutaneous transthoracic biopsy
- Type of treatment
- Injection or infusion
- How many people
- 240 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2020to 20 Feb 2021
- 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: The study comprised 240 patients who received a transthoracic lung biopsy using the percutaneous coaxial technique at Trakya University Faculty of Medicine, Department of Radiology, Interventional Radiology unit, between January 1, 2015 and September 14, 2020.
Who may be able to join
- Patients older than 18 years
- Patients who underwent percutaneous transthoracic tru cut biopsy
- Patients undergoing interventional procedures by radiologists with equal experience
- Patients who were able to obtain sufficient samples with the applied biopsy (technical success of percutaneous transthoracic biopsy)
- Patients whose medical records are fully accessible and whose data are reliable
Who cannot join
- Patients whose laboratory bleeding parameters are not suitable for the procedure (platelets<100000/mm3, INR>1.5)
- Pregnancy
- Patients with increased risk of pneumothorax due to other etiologies (bulla, blep, chronic obstructive pulmonary disease, cystic fibrosis)
- Patients receiving anticoagulant antiplatelet therapy
- Patients with persistent cough
- Patients with a history of recent lung travma, pneumothorax, hemoptysis or pulmonary hemorrhage
Show all 11Show fewer
- Patients with severe psychiatric diseases such as psychosis or dementia that limit cooperation with the patient
- Patients with anatomic deformity (advanced scoliosis and kyphotic patients. Patients with pectus carinatum and pectus excavatum-like chest deformity)
- Patients for whom tru cut biopsy is absolutely and relative contraindicated (suspected hydatid cyst or known vascular lesions such as arteriovenous malformation, pulmonary varicose, severe obstructive pulmonary disease, coagulopathy, moderate to severe pulmonary hypertension, ventilator dependence, unilateral pneumectomy)
- Patients allergic to local anesthetic drug used for skin and subcutaneous tissue anesthesia
- Patients who do not want to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the the Effectiveness of the Autologous Blood Patch Method in Transthoracic Lung Biopsies Using the Coaxial Technique
In this retrospective study, investigators aimed to evaluate the effectiveness of the autologous blood patch method in percutaneous transthoracic lung biopsies performed with the coaxial technique.
Read the detailed description
In this retrospective study, investigators aimed to evaluate the effectiveness of the autologous blood patch method in percutaneous transthoracic lung biopsies performed with the coaxial technique. Biopsies and treatment modalities were performed according to approved guidelines. Ethics committee approval was obtained for the retrospective evaluation of the files and images of the participants. Written informed consent was obtained from all participants before biopsy procedures. Percutaneous transthoracic biopsies (PTB) have been started to be performed with the coaxial technique using the autologous blood patch method as of April 2019 in Interventional Radiology Department of Trakya University Hospital. All lung biopsies are performed using the blood patch method as a standard, as a clear decrease in procedural complications was observed in a short time. Thus, in this study, participants who underwent biopsy after April 2019 formed the participant group that underwent autologous blood patch, and those who had the procedure before this date formed the control group. Since autologous blood patch application was not performed before this date, participant grouping was time-dependent.
All participants included in the study underwent tru-cut biopsy with the coaxial technique. Of the 240 participants included in the study, 120 were treated with an autologous blood patch ( Group A), and the remaining 120 were participants without an autologous blood patch (Group B).
Procedure:
All biopsy procedures were performed by four interventional radiologists with at least 2 years of experience. First of all, after determining the lung lobe where the lesion was observed, axial CT images of 5 mm cross-section thickness were obtained so that the upper and lower parts of it could be visualized. After ruling the entry site in the skin, antisepsis and local anesthesia were performed. The coaxial system (17 G) was cautiously advanced and CT images were continuously evaluated to confirm entrance into the lesion. Approximately 3-4 pieces were taken with the 18 G core biopsy needle until sufficient tissue was obtained. In the autologous blood patch technique, approximately 6-7 ml of blood was taken from the participants with a 10 ml syringe before the procedure. By attaching a 3-way tap to the injector from which the blood is drawn, blood is drawn into a second injector to ensure that the clotted blood is dispersed and homogenized. After the above-mentioned procedures, and after sufficient tissue samples were taken at the last stage of the biopsy procedure, control CT imaging, including the whole lung, was performed to evaluate complications. The presences of pneumothorax were noted. The prepared autologous blood patch was given through the coaxial needle (approximately 1 ml of autologous blood patch was applied for every 1 cm when the coaxial needle was withdrawn) and the tract formed by the biopsy needle in the parenchyma, pleura, and under the skin was closed with the participant's autologous blood. Thus, it was aimed at preventing pneumothorax or reducing its severity if it occurred. The tract formed by the given autologous blood patch into the parenchyma can be observed in most biopsies. The lesion and lung parenchyma features, pneumothorax and other complications of the participants included in the study were evaluated through biopsy planning and follow-up images in hospital medical record system. It is known that transthoracic lung biopsies performed with the coaxial technique increase the diagnostic accuracy. In addition, by obtaining more than one tissue piece with a single entry, more tissue pieces can be sampled for histopathological studies as well as molecular and genetic analysis, which has become increasingly important recently. As a result, investigators think that the use of this method will increase, as more tissue material can be obtained in percutaneous transthoracic lung biopsies performed with coaxial technique and computed tomography using the autologous blood patch method, while reducing the risk of pneumothorax, the most common complication, at the same time.
- Conditions
- Lung Cancer, Pneumothorax
- Being tested
- Autologous blood patch, Percutaneous transthoracic biopsy
- Keywords
- lung cancer, pneumothorax, computed tomography, biopsy
- Medical subject headings
- Lung Neoplasms, Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous blood patchOther
Approximately 3-4 pieces were taken with the 18 G core biopsy needle until sufficient tissue was obtained. In the autologous blood patch technique, approximately 6-7 ml of blood was taken from the patient with a 10 ml syringe before the procedure. By attaching a 3-way tap to the injector from which the blood is drawn, blood is drawn into a second injector to ensure that the clotted blood is dispersed and homogenized. The prepared autologous blood patch was given through the coaxial needle (approximately 1 ml of autologous blood patch was applied for every 1 cm when the coaxial needle was withdrawn) and the tract formed by the biopsy needle in the parenchyma, pleura, and under the skin was closed with the patient's autologous blood.
Percutaneous transthoracic biopsyOther
After determining the lung lobe where the lesion was observed, axial CT images of 5 mm cross-section thickness were obtained so that the upper and lower parts of it could be visualized. After ruling the entry site in the skin, antisepsis and local anesthesia were performed. The coaxial system (17 G) was cautiously advanced and CT images were continuously evaluated to confirm entrance into the lesion. Biopsy was taken and after sufficient tissue samples were taken at the last stage of the biopsy procedure, control CT imaging, including the whole lung, was performed to evaluate complications. The presences of pneumothorax were noted.
| Study group | Role | What they receive |
|---|---|---|
| A | The patients who underwent tru-cut biopsy with the coaxial technique and applied an autologous blood patch. Receives: Other: Autologous blood patch; Other: Percutaneous transthoracic biopsy | |
| B | The patients whose true-cut biopsy with coaxial technique was taken and autologous blood patch was not applied. Receives: Other: Percutaneous transthoracic biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumothorax incidence
Development of pneumothorax after biopsy as a complication
Measured: first 24 hours
Secondary outcomes (1)
Chest tube placement incidence
Incidence of patients needing chest tube after biopsy
Measured: Immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start20 Oct 2020
- Primary completion20 Nov 2020
- Study completion20 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak USLU, Trakya University
- Investigators
- Burak USLU, MD, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904574
- Sponsor's protocol ID
- TTLBABPTU21
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All patient data is stored in an institutionally encrypted medical system and cannot be shared openly.
Publications
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
PubMed 31912902Casal-Mourino A, Valdes L, Barros-Dios JM, Ruano-Ravina A. Lung cancer survival among never smokers. Cancer Lett. 2019 Jun 1;451:142-149. doi: 10.1016/j.canlet.2019.02.047. Epub 2019 Mar 6.
PubMed 30851418Marshall D, Laberge JM, Firetag B, Miller T, Kerlan RK. The changing face of percutaneous image-guided biopsy: molecular profiling and genomic analysis in current practice. J Vasc Interv Radiol. 2013 Aug;24(8):1094-103. doi: 10.1016/j.jvir.2013.04.027. Epub 2013 Jun 24.
PubMed 23806383Hiraki T, Mimura H, Gobara H, Shibamoto K, Inoue D, Matsui Y, Kanazawa S. Incidence of and risk factors for pneumothorax and chest tube placement after CT fluoroscopy-guided percutaneous lung biopsy: retrospective analysis of the procedures conducted over a 9-year period. AJR Am J Roentgenol. 2010 Mar;194(3):809-14. doi: 10.2214/AJR.09.3224.
PubMed 20173164Heerink WJ, de Bock GH, de Jonge GJ, Groen HJ, Vliegenthart R, Oudkerk M. Complication rates of CT-guided transthoracic lung biopsy: meta-analysis. Eur Radiol. 2017 Jan;27(1):138-148. doi: 10.1007/s00330-016-4357-8. Epub 2016 Apr 23.
PubMed 27108299
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the the Effectiveness of the Autologous Blood Patch Method in Transthoracic Lung Biopsies Using the Coaxial Technique
- ClinicalTrials.gov ID
- NCT05904574
- Acronym / sponsor ID
- TTLBABPTU21
- Conditions
- Lung Cancer, Pneumothorax
- Keywords
- lung cancer, pneumothorax, computed tomography, biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Feb 2021 (actual)
- First posted
- 15 Jun 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.
In this retrospective study, investigators aimed to evaluate the effectiveness of the autologous blood patch method in percutaneous transthoracic lung biopsies performed with the coaxial technique.
Detailed description
In this retrospective study, investigators aimed to evaluate the effectiveness of the autologous blood patch method in percutaneous transthoracic lung biopsies performed with the coaxial technique. Biopsies and treatment modalities were performed according to approved guidelines. Ethics committee approval was obtained for the retrospective evaluation of the files and images of the participants. Written informed consent was obtained from all participants before biopsy procedures. Percutaneous transthoracic biopsies (PTB) have been started to be performed with the coaxial technique using the autologous blood patch method as of April 2019 in Interventional Radiology Department of Trakya University Hospital. All lung biopsies are performed using the blood patch method as a standard, as a clear decrease in procedural complications was observed in a short time. Thus, in this study, participants who underwent biopsy after April 2019 formed the participant group that underwent autologous blood patch, and those who had the procedure before this date formed the control group. Since autologous blood patch application was not performed before this date, participant grouping was time-dependent.
All participants included in the study underwent tru-cut biopsy with the coaxial technique. Of the 240 participants included in the study, 120 were treated with an autologous blood patch ( Group A), and the remaining 120 were participants without an autologous blood patch (Group B).
Procedure:
All biopsy procedures were performed by four interventional radiologists with at least 2 years of experience. First of all, after determining the lung lobe where the lesion was observed, axial CT images of 5 mm cross-section thickness were obtained so that the upper and lower parts of it could be visualized. After ruling the entry site in the skin, antisepsis and local anesthesia were performed. The coaxial system (17 G) was cautiously advanced and CT images were continuously evaluated to confirm entrance into the lesion. Approximately 3-4 pieces were taken with the 18 G core biopsy needle until sufficient tissue was obtained. In the autologous blood patch technique, approximately 6-7 ml of blood was taken from the participants with a 10 ml syringe before the procedure. By attaching a 3-way tap to the injector from which the blood is drawn, blood is drawn into a second injector to ensure that the clotted blood is dispersed and homogenized. After the above-mentioned procedures, and after sufficient tissue samples were taken at the last stage of the biopsy procedure, control CT imaging, including the whole lung, was performed to evaluate complications. The presences of pneumothorax were noted. The prepared autologous blood patch was given through the coaxial needle (approximately 1 ml of autologous blood patch was applied for every 1 cm when the coaxial needle was withdrawn) and the tract formed by the biopsy needle in the parenchyma, pleura, and under the skin was closed with the participant's autologous blood. Thus, it was aimed at preventing pneumothorax or reducing its severity if it occurred. The tract formed by the given autologous blood patch into the parenchyma can be observed in most biopsies. The lesion and lung parenchyma features, pneumothorax and other complications of the participants included in the study were evaluated through biopsy planning and follow-up images in hospital medical record system. It is known that transthoracic lung biopsies performed with the coaxial technique increase the diagnostic accuracy. In addition, by obtaining more than one tissue piece with a single entry, more tissue pieces can be sampled for histopathological studies as well as molecular and genetic analysis, which has become increasingly important recently. As a result, investigators think that the use of this method will increase, as more tissue material can be obtained in percutaneous transthoracic lung biopsies performed with coaxial technique and computed tomography using the autologous blood patch method, while reducing the risk of pneumothorax, the most common complication, at the same time.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: Autologous blood patch, Other: Percutaneous transthoracic biopsyThe patients who underwent tru-cut biopsy with the coaxial technique and applied an autologous blood patch. |
| B | – | Other: Percutaneous transthoracic biopsyThe patients whose true-cut biopsy with coaxial technique was taken and autologous blood patch was not applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study comprised 240 patients who received a transthoracic lung biopsy using the percutaneous coaxial technique at Trakya University Faculty of Medicine, Department of Radiology, Interventional Radiology unit, between January 1, 2015 and September 14, 2020.
Key inclusion criteria (5 listed)
- Patients older than 18 years
- Patients who underwent percutaneous transthoracic tru cut biopsy
- Patients undergoing interventional procedures by radiologists with equal experience
- Patients who were able to obtain sufficient samples with the applied biopsy (technical success of percutaneous transthoracic biopsy)
- Patients whose medical records are fully accessible and whose data are reliable
Key exclusion criteria (11 listed)
- Patients whose laboratory bleeding parameters are not suitable for the procedure (platelets<100000/mm3, INR>1.5)
- Pregnancy
- Patients with increased risk of pneumothorax due to other etiologies (bulla, blep, chronic obstructive pulmonary disease, cystic fibrosis)
- Patients receiving anticoagulant antiplatelet therapy
- Patients with persistent cough
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 |
|---|---|---|
| Autologous blood patchApproximately 3-4 pieces were taken with the 18 G core biopsy needle until sufficient tissue was obtained. In the autologous blood patch technique, approximately 6-7 ml of blood was taken from the patient with a 10 ml syringe before the procedure. By attaching a 3-way tap to the injector from which the blood is drawn, blood is drawn into a second injector to ensure that the clotted blood is dispersed and homogenized. The prepared autologous blood patch was given through the coaxial needle (approximately 1 ml of autologous blood patch was applied for every 1 cm when the coaxial needle was withdrawn) and the tract formed by the biopsy needle in the parenchyma, pleura, and under the skin was closed with the patient's autologous blood. | Other | A |
| Percutaneous transthoracic biopsyAfter determining the lung lobe where the lesion was observed, axial CT images of 5 mm cross-section thickness were obtained so that the upper and lower parts of it could be visualized. After ruling the entry site in the skin, antisepsis and local anesthesia were performed. The coaxial system (17 G) was cautiously advanced and CT images were continuously evaluated to confirm entrance into the lesion. Biopsy was taken and after sufficient tissue samples were taken at the last stage of the biopsy procedure, control CT imaging, including the whole lung, was performed to evaluate complications. The presences of pneumothorax were noted. | Other | A, B |
Primary outcome
Pneumothorax incidence
Time frame: first 24 hours
Development of pneumothorax after biopsy as a complication
1 secondary outcome
Chest tube placement incidence
Time frame: Immediately after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Results publication: PubMed 31912902Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
- Results publication: PubMed 30851418Casal-Mourino A, Valdes L, Barros-Dios JM, Ruano-Ravina A. Lung cancer survival among never smokers. Cancer Lett. 2019 Jun 1;451:142-149. doi: 10.1016/j.canlet.2019.02.047. Epub 2019 Mar 6.
- Results publication: PubMed 23806383Marshall D, Laberge JM, Firetag B, Miller T, Kerlan RK. The changing face of percutaneous image-guided biopsy: molecular profiling and genomic analysis in current practice. J Vasc Interv Radiol. 2013 Aug;24(8):1094-103. doi: 10.1016/j.jvir.2013.04.027. Epub 2013 Jun 24.
- Results publication: PubMed 20173164Hiraki T, Mimura H, Gobara H, Shibamoto K, Inoue D, Matsui Y, Kanazawa S. Incidence of and risk factors for pneumothorax and chest tube placement after CT fluoroscopy-guided percutaneous lung biopsy: retrospective analysis of the procedures conducted over a 9-year period. AJR Am J Roentgenol. 2010 Mar;194(3):809-14. doi: 10.2214/AJR.09.3224.
- Results publication: PubMed 27108299Heerink WJ, de Bock GH, de Jonge GJ, Groen HJ, Vliegenthart R, Oudkerk M. Complication rates of CT-guided transthoracic lung biopsy: meta-analysis. Eur Radiol. 2017 Jan;27(1):138-148. doi: 10.1007/s00330-016-4357-8. Epub 2016 Apr 23.
- Individual participant dataSharing planned: No. All patient data is stored in an institutionally encrypted medical system and cannot be shared openly.
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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.
Burak USLU, MD principal investigator
Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Pneumothorax, run by Trakya University at 1 site in Turkey (Türkiye).
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 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 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 Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumothorax incidence (time frame: first 24 hours). 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 NCT05904574, which also lists 5 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 18 Jun 2023.