RecruitingNot ApplicableNCT06651658

Oxford Pleural Embolisation Trial

Pleural Blood Patch for Lung Ablation: a Randomised Trial (Oxford Pleural Embolisation Trial - OxPET)


Sponsor

Oxford University Hospitals NHS Trust

Enrollment

106 participants

Start Date

Nov 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Thermal ablation is an established treatment for lung cancer. It involves insertion of a applicator under image guidance into a lung tumour and destroying it with radiofrequency, microwave or cryotherapy. One of the common side effects is pneumothorax, which is a leak of gas from the lungs when it punctured. Air leak necessitates placement of a drainage tube in more than half of patients undergoing the procedure. The drain can be associated with some morbidity including pain, reduced mobility, prolonged hospital stay and infection Pleural embolization refers to the injection of substances to the linings of the lung to seal air leakage. There is published evidence in using pleural embolization with autologous blood (blood drawn up from the patient's veins) to prevent pneumothorax in patients undergoing lung biopsies. This technique is also known as pleural blood patch (PBP). A study involving more than 4000 patients found that PBP reduced the rates of pneumothorax by 35% and drain placement by 55% in lung patients. A study using prophylactic gelfoam torpedo embolization for radiofrequency ablation showed significant reduction in chest drain rates. In this study, investigators plan to evaluate the PBP using a tandem needle technique in patients undergoing lung ablation at the Oxford Thermal Ablation Service, one of the largest units in the country performing about 200 ablations per year, mostly microwave ablations. Patients will be randomized to receive lung ablation with or without the PBP. The PBP technique is easy to learn, enjoys high technical success rates and does not expose the patient to any significant additional risk. The primary outcome is the chest drains rates in the two trial groups: 1. patients undergoing lung ablation without PBP and 2. patients undergoing lung ablation with PBP. Other outcomes that would be measured include the volume of gas leakage on Computed Tomography (CT) imaging, safety profile, length of stay, feasibility of same day discharge, patient oriented outcomes including validated pain score, and institution oriented outcomes including medical costs. A positive trial could significantly reduce the side effect profile of lung ablation and hasten the patient's recovery. There could be significant savings in healthcare costs as the procedure may become safe to perform as a day procedure as opposed to an overnight procedure.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a technique called pleural embolisation — sealing small blood vessels near lung lesions before an ablation procedure — to reduce bleeding complications during lung tumor ablation (a minimally invasive treatment that destroys lung tumors using heat, cold, or other energy). **You may be eligible if...** - You have been recommended by your doctor for lung ablation treatment - You are 18 or older - You are willing and able to give informed consent **You may NOT be eligible if...** - You are unable to proceed with the lung ablation procedure - You have 3 or more lung lesions that need to be treated in the same session Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREPleural embolisation

Administration of pleural blood patch with tandem needle technique


Locations(1)

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06651658


Related Trials