A Prospective, Randomized Clinical Trial to Evaluate the Feasibility of Miniature Cryoprobe Biopsy to Detect Acute and Chronic Lung Transplant Rejection in Lung Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Quality and diagnostic yield of tissue samples
研究概览
简要总结
The goal of this clinical trial is to evaluate which biopsy collection method helps to better diagnose rejection and relevant pathologic findings in lung transplant recipients. The main questions it aims to answer are:
Does the 1.1 mm cryoprobe or the biopsy forceps provide better quality samples of lung tissue for detecting rejection in transplant recipients?
How much tissue is adequate for lung transplant 1.1 mm cryobiopsy samples as compared to biopsy forceps?
Which samples received by the pathologist did they find they were most confident to exclude rejection, based on their satisfaction with the samples?
Which collection method has the least amount of procedural time?
Researchers will compare lung tissue samples obtained using a 1.1mm cryoprobe and a biopsy forceps during the lung transplant.
Participants will:
Be randomly assigned to receive either the cryoprobe or biopsy forceps collection method at the time of biopsy.
Assessed for any adverse events following the biopsy for up to 30 days after transplant.
详细描述
The purpose of this 1:1 randomized clinical trial is to compare the histological quality and diagnostic yield of tissue samples acquired using a 1.1 mm cryoprobe with those obtained with biopsy forceps in lung transplant recipients for graft surveillance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
盲法说明
Allocation will not be known to either the patient or bronchoscopist until the intra-procedural randomization timepoint, after which blinding of the bronchoscopist is not possible due to the nature of the procedure.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female lung transplant recipients age >18 at the time of informed consent
- •Patients clinically meet indication for post-transplant lung biopsy or planned routine surveillance and have been scheduled for bronchoscopy with transbronchial biopsy.
- •Be willing and able to sign the informed consent.
排除标准
- •Patients with known bleeding diathesis
- •Platelet count <50,000 per μL within 14 days of the biopsy procedure
- •Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable)
- •Inability or unwillingness to give informed consent or study procedures
- •Pregnant or nursing females, or females who intend to become pregnant
- •Females of child-bearing potential who decline a pregnancy test prior to enrollment
- •If an investigator does not feel that this study is in the subject's best interest or would be a good fit for the study.
- •International Normalized Ratio (INR) >1.5
- •Do Not Resuscitate (DNR) status
- •Do Not Intubate (DNI) status
- •Single lung transplant recipients
研究组 & 干预措施
Cryoprobe Biopsy Method
Cryoprobes which are flexible catheters that can be passed through the channel of a bronchoscope. Rapid cooling of tissue results from the Joule-Thomson effect which causes tissue to freeze and adhere to the probe. The biopsy is obtained by subsequently avulsing small fragments of tissue.
干预措施: Cryoprobe Biopsy (Device)
Forceps Biopsy Method
Olympus disposable EndoJaw is used to obtain samples as per the standard of clinical care usually resulting in crush artifact.
干预措施: Forceps Biopsy (Device)
结局指标
主要结局
Quality and diagnostic yield of tissue samples
时间窗: Baseline
Histological accessibility grade is determined by the pathologist according to the Lung Allograft Standard Histological Analysis (LASHA) scale and the 2007 Revision of the 1996 working formulation for the Standardization of Nomenclature in the Diagnosis of Lung Rejection, published by the ISHLT.
次要结局
- Time duration(Baseline)
- Tissue sample adequacy(Baseline)
研究者
John O. Joerns
Principal Investigator
Mayo Clinic