Pleural Blood Patch for Lung Ablation: a Randomised Trial (Oxford Pleural Embolisation Trial - OxPET)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Perioperative chest drain insertion
研究概览
简要总结
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:
- patients undergoing lung ablation without PBP and
- 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.
详细描述
Background and existing literature Image guided thermal ablation is an established treatment for lung malignancy including early stage primary cancer and oligometastases. It is a minimally invasive technique associated with rapid clinical recovery and its efficacy and safety are comparable to surgical resection and radiotherapy. It is also repeatable and feasible for patients contraindicated to other therapies, such as those with impaired lung function or interstitial fibrosis.
One of the most common side effects of lung ablation is pneumothorax, occurring in up to 67% of patients depending on definition. Clinically significant pneumothorax, typically defined as requiring perioperative insertion of chest drain, occurs in up to 58% of patients. In a local audit at Oxford University Hospitals last year, 31.7% of lung ablation patients required a chest drain.
Pleural or parenchymal tract embolisation using autologous blood (pleural blood patch/ PBP) is a recognized technique in pneumothorax prevention in image guided lung biopsies. In a meta-analysis including more than 4000 patients, drawing on mainly retrospective studies, this reduces the risk of pneumothorax by 35% and risks of chest drain by 55%.
A study using prophylactic gelfoam torpedo embolisation for radiofrequency ablation showed significant reduction in chest drain rates.
Rationale and necessity of the OxPET trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically indicated for lung ablation.
- •Willing and capable of giving informed consent.
- •Aged 18 years or above.
排除标准
- •Unable to proceed to lung ablation procedure.
- •3 or more lung lesions to be ablated in the same setting.
研究组 & 干预措施
Lung ablation only
Patients proceed to standard of care treatment with lung ablation as deemed clinically appropriate
Lung ablation with pleural embolisation
In addition of standard of care lung ablation, patients undergo pleural blood patch embolisation during withdrawal of the ablation probe
干预措施: Pleural embolisation (Procedure)
结局指标
主要结局
Perioperative chest drain insertion
时间窗: (<24 hours)
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.
次要结局
- 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)
- Feasibility of same day discharge(Assessed at discharge, typically day after procedure)
研究者
Yan-Lin Li
Chief Investigator
Oxford University Hospitals NHS Trust