Effectiveness of the Autologous Blood Patch Method in Lung Biopsies

NCT05904574 | Completed

• 1 other identifier: TTLBABPTU21
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer; Pneumothorax

Keywords

lung cancer; pneumothorax; computed tomography; biopsy

Outcome Measures

Primary Outcomes (1)

• Pneumothorax incidence

  Development of pneumothorax after biopsy as a complication

  first 24 hours

Secondary Outcomes (1)

• Chest tube placement incidence

  Immediately after procedure

Study Arms (2)

A

The patients who underwent tru-cut biopsy with the coaxial technique and applied an autologous blood patch.

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.

Other: Percutaneous transthoracic biopsy

Interventions

Autologous blood patch OTHER

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the coaxial needle (approximately 1 ml of autologous blood patch was applied for every 1 cm when the coaxial needle was withdrawn) and the tract formed by the biopsy needle in the parenchyma, pleura, and under the skin was closed with the patient's autologous blood.

A

Percutaneous transthoracic biopsy OTHER

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.

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University

Edirne, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 31912902 RESULT

• Casal-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.

  PMID: 30851418 RESULT

• Marshall 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.

  PMID: 23806383 RESULT

• Hiraki 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.

  PMID: 20173164 RESULT

• Heerink 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.

  PMID: 27108299 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Pneumothorax

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pleural Diseases

Study Officials

• Burak USLU, MD

  Trakya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 15, 2023
• Study Start: October 20, 2020
• Primary Completion: November 20, 2020
• Study Completion: February 20, 2021
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)