Lung BiopsyNCT04415255
Novel Use of Extrapleural Autologous Blood Injection in CT-guided Percutaneous Lung Biopsy
A study testing EABPI plus IABPI and IABPI-alone in people with Lung Biopsy, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI) along with intraparenchymal autologous blood patch injection (IABPI) or IABPI-alone in CT-guided percutaneous lung biopsy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Biopsy
- What is being tested?
- EABPI plus IABPI and IABPI-alone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2018to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥18 years of age
- Referred for CT guided biopsy of lung lesion
- Target lesion of any size
- Target lesion located any away from visceral pleura based on the needle path
- Needle path without transgression of a pleural fissure, bleb, or bulla is possible
- Coaxial biopsy technique using Bard 19-Gauge introducer needle
- Needle length =16
Who cannot join
- Passage through non-aerated lung or tissue
- More than 1 biopsy on the same side requiring more than 1 pleural puncture
- History of prior ipsilateral lung interventions including:
- Chest tube placement Surgery Pleurodesis Radiation treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tekirdag Namik Kemal University Medical Faculty Radiology Department
Tekirdağ, 59100
About this study
Official title: Novel Use of Extrapleural Autologous Blood Injection in CT-guided Percutaneous Lung Biopsy and Its Comparison to Intraparenchymal Autologous Blood Patch Injection: A Single-center, Prospective, Randomized, and Controlled Clinical Trial
The purpose of this study is to evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI) along with intraparenchymal autologous blood patch injection (IABPI) or IABPI-alone in CT-guided percutaneous lung biopsy.
Read the detailed description
The mechanism of pneumothorax is postulated to be due to the air leakage through the puncture hole when the needle is removed after the biopsy. However, pneumothorax may occur during the needle insertion as the visceral pleura is punctured or during the biopsy procedure before needle removal. Prevent such leakage, the investigators planned to inject autologous blood into the extrapleural space to prevent pneumothorax during needle entry. The extrapleural autologous blood injection (EPABI) is expected to form a space-occupying hematoma pressing on visceral pleura as a sealant. The investigators planned to test the EPABI method in a prospective single-center randomized controlled study design.
- Conditions
- Lung Biopsy
- Being tested
- EABPI plus IABPI, IABPI-alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EABPI plus IABPIOther
If the patient was assigned to EPABI plus IABPI, while the extrapleural space was reached, ~ 15 ml of autologous blood was injected at the extrapleural space through the coaxial needle. Then the central stylet was reinserted and the coaxial needle was advanced into the lung parenchyma with a single puncture. The needle was stopped inside the proximal part of the target and the center needle was removed. A 20-G/16 cm fully-automated biopsy needle was introduced through the 19-G/13.8 cm coaxial needle and specimens were identically obtained. After specimens were collected, the biopsy needle was removed, and immediately the remaining autologous blood (~5 ml) was slowly injected through the coaxial needle as it was withdrawn through the parenchyma thus sealing the needle tract.
IABPI-aloneOther
If the patient was assigned to IABPI-alone, after collecting the biopsy specimens, immediately the autologous blood (~5 ml) was slowly injected through the coaxial needle as it was withdrawn through the parenchyma thus sealing the needle tract.
| Study group | Role | What they receive |
|---|---|---|
| EPABI & IABPI | Experimental | extrapleural autologous blood injection (EPABI) along with intraparenchymal autologous blood patch injection (IABPI) Receives: Other: EABPI plus IABPI |
| IABPI-alone | Active comparator | intraparenchymal autologous blood patch injection (IABPI) Receives: Other: IABPI-alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI)
the rate of pneumothorax
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Oct 2018
- Primary completion30 Apr 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasar Turk, Namik Kemal University
- Investigators
- Yasar Turk, Principal investigator, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415255
- Sponsor's protocol ID
- 18-AKD-150
- Other IDs
- 13.07.2018 1.0
- Status last verified
- Jun 2020
- First submitted
- 29 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Use of Extrapleural Autologous Blood Injection in CT-guided Percutaneous Lung Biopsy and Its Comparison to Intraparenchymal Autologous Blood Patch Injection: A Single-center, Prospective, Randomized, and Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04415255
- Acronym / sponsor ID
- 18-AKD-150
- Conditions
- Lung Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 4 Jun 2020 (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 purpose of this study is to evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI) along with intraparenchymal autologous blood patch injection (IABPI) or IABPI-alone in CT-guided percutaneous lung biopsy.
Detailed description
The mechanism of pneumothorax is postulated to be due to the air leakage through the puncture hole when the needle is removed after the biopsy. However, pneumothorax may occur during the needle insertion as the visceral pleura is punctured or during the biopsy procedure before needle removal. Prevent such leakage, the investigators planned to inject autologous blood into the extrapleural space to prevent pneumothorax during needle entry. The extrapleural autologous blood injection (EPABI) is expected to form a space-occupying hematoma pressing on visceral pleura as a sealant. The investigators planned to test the EPABI method in a prospective single-center randomized controlled study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPABI & IABPI | Experimental | Other: EABPI plus IABPIextrapleural autologous blood injection (EPABI) along with intraparenchymal autologous blood patch injection (IABPI) |
| IABPI-alone | Active comparator | Other: IABPI-aloneintraparenchymal autologous blood patch injection (IABPI) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18 years of age
- Referred for CT guided biopsy of lung lesion
- Target lesion of any size
- Target lesion located any away from visceral pleura based on the needle path
- Needle path without transgression of a pleural fissure, bleb, or bulla is possible
Key exclusion criteria (4 listed)
- Passage through non-aerated lung or tissue
- More than 1 biopsy on the same side requiring more than 1 pleural puncture
- History of prior ipsilateral lung interventions including:
- Chest tube placement Surgery Pleurodesis Radiation treatment
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 |
|---|---|---|
| EABPI plus IABPIIf the patient was assigned to EPABI plus IABPI, while the extrapleural space was reached, ~ 15 ml of autologous blood was injected at the extrapleural space through the coaxial needle. Then the central stylet was reinserted and the coaxial needle was advanced into the lung parenchyma with a single puncture. The needle was stopped inside the proximal part of the target and the center needle was removed. A 20-G/16 cm fully-automated biopsy needle was introduced through the 19-G/13.8 cm coaxial needle and specimens were identically obtained. After specimens were collected, the biopsy needle was removed, and immediately the remaining autologous blood (~5 ml) was slowly injected through the coaxial needle as it was withdrawn through the parenchyma thus sealing the needle tract. | Other | EPABI & IABPI |
| IABPI-aloneIf the patient was assigned to IABPI-alone, after collecting the biopsy specimens, immediately the autologous blood (~5 ml) was slowly injected through the coaxial needle as it was withdrawn through the parenchyma thus sealing the needle tract. | Other | IABPI-alone |
Primary outcome
To evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI)
Time frame: 1 years
the rate of pneumothorax
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 9 Jun 2020.
- 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.
Yasar Turk principal investigator
Namik Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EABPI plus IABPI and IABPI-alone in people with Lung Biopsy, run by Namik Kemal 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 7 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: finished, as of the sponsor's last update on 9 Jun 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 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?
To evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI) (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2020.