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

Lung Biopsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04415255
• Other study ID #: 18-AKD-150
• Secondary ID: 13.07.2018 1.0
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: June 2020
• Source: Namik Kemal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: October 31, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Biopsy

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Tekirdag Namik Kemal University Medical Faculty Radiology Department	Tekirdag

Sponsors (1)

Lead Sponsor	Collaborator
Namik Kemal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI)	the rate of pneumothorax	1 years