Novel Use of Extrapleural Autologous Blood Injection in CT-guided Percutaneous Lung Biopsy

NCT ID: NCT04415255

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-10-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EPABI & IABPI

extrapleural autologous blood injection (EPABI) along with intraparenchymal autologous blood patch injection (IABPI)

Group Type: EXPERIMENTAL

EABPI plus IABPI

Intervention Type: 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and immediately the remaining autologous blood (\~5 ml) was slowly injected through the coaxial needle as it was withdrawn through the parenchyma thus sealing the needle tract.

IABPI-alone

intraparenchymal autologous blood patch injection (IABPI)

Group Type: ACTIVE_COMPARATOR

IABPI-alone

Intervention Type: 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.

Interventions

EABPI plus IABPI

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.

Intervention Type: OTHER

IABPI-alone

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ≥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

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Namik Kemal University

OTHER

Sponsor Role: lead

Responsible Party

Yasar Turk

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasar Turk

Role: PRINCIPAL_INVESTIGATOR

Namik Kemal University

Locations

Tekirdag Namik Kemal University Medical Faculty Radiology Department

Tekirdağ, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

13.07.2018 1.0

Identifier Type: OTHER

Identifier Source: secondary_id

18-AKD-150

Identifier Type: -

Identifier Source: org_study_id