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| ID | Type | Description | Link |
|---|---|---|---|
| 13.07.2018 1.0 | Other Identifier | Tekirdağ NKU Clinical Research Ethics Committee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPABI & IABPI | Experimental | extrapleural autologous blood injection (EPABI) along with intraparenchymal autologous blood patch injection (IABPI) |
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| IABPI-alone | Active Comparator | intraparenchymal autologous blood patch injection (IABPI) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EABPI plus IABPI | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI) | the rate of pneumothorax | 1 years |
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Inclusion Criteria:
Exclusion Criteria:
Chest tube placement Surgery Pleurodesis Radiation treatment
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| Name | Affiliation | Role |
|---|---|---|
| Yasar Turk | Namik Kemal University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tekirdag Namik Kemal University Medical Faculty Radiology Department | Tekirdağ | 59100 | Turkey (Türkiye) |
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| IABPI-alone | Other | 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. |
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