Oxford Pleural Embolisation Trial

NCT06651658 | Recruiting

• 1 other identifier: 18274
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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. 1.patients undergoing lung ablation without PBP and
2. 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.

Conditions

Lung Cancer; Lung Metastases

Keywords

lung cancer; lung metastases; lung ablation; pleural embolisation; Pleural blood patch

Outcome Measures

Primary Outcomes (1)

• Perioperative chest drain insertion

  To compare the rates of clinically important pneumothorax in patients undergoing lung ablation with or without pleural blood patch embolisation Chest drain rates (%) are expressed in means and standard deviations.

  (<24 hours)

Secondary Outcomes (6)

• Pneumothorax volume on immediate post ablation CT imaging

  Immediate post operative

• Technical success in interventional group

  immediate post operative

• Adverse events deemed due to PBP

  Through study completion, an average of 3 months

• Pain score

  Assessed at discharge, typically day after procedure

• Length of stay

  Assessed at discharge, typically day after procedure

Study Arms (2)

Lung ablation only

NO INTERVENTION

Patients proceed to standard of care treatment with lung ablation as deemed clinically appropriate

Lung ablation with pleural embolisation

EXPERIMENTAL

In addition of standard of care lung ablation, patients undergo pleural blood patch embolisation during withdrawal of the ablation probe

Procedure: Pleural embolisation

Interventions

Pleural embolisation PROCEDURE

Administration of pleural blood patch with tandem needle technique

Lung ablation with pleural embolisation

Eligibility Criteria

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

You may qualify if:

• Clinically indicated for lung ablation.
• Willing and capable of giving informed consent.
• Aged 18 years or above.

You may not qualify if:

• Unable to proceed to lung ablation procedure.
• or more lung lesions to be ablated in the same setting.

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

RECRUITING

Related Publications (1)

• Li YL, Tan Y, Shah R, Harris V, Dmytriw A, Gleeson F, Scott S, Lyon P, Anderson EM. Tandem Needle Technique Pleural Blood Patch Embolisation for Lung Ablations. Cardiovasc Intervent Radiol. 2025 Dec 14. doi: 10.1007/s00270-025-04301-6. Online ahead of print.

  PMID: 41392212 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Dr Yan-Lin Li Consultant Interventional Radiologist, EBIR FRCR FHKAM

  Oxford University Hospitals NHS Foundation Trust/ University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Yan-Lin Li Consultant Interventional Radiologist, EBIR FRCR FHKAM

CONTACT

44 1865 235746; yan-lin.li@ouh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 22, 2024
• Study Start: November 24, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)