一个随机对照试验的冷探针与叉子用于横支气管活检 (FROSTBITE-2):多中心实用性临床试验的研究协议
Jeffrey Thiboutot1, Ardian Latifi1, Peter Illei2
1Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, MD, United States of America.
Contemporary clinical trials
|February 5, 2026
概括
通过支气管活检的新型冷探针可能会改善与传统相比的诊断产量. 这项随机试验将1.1毫米冷探针与子进行比较,用于肺部疾病诊断.
科学领域:
- 肺部病理学 肺部病理学
- 干预性肺病学 干预性肺病学
- 胸部外科手术 胸部外科手术
背景情况:
- 跨支气管活检对于诊断肺部疾病至关重要,但在使用子时,通常会产生具有粉碎工件的小样本.
- 一个新的1.1毫米冷探针旨在通过使用快速冷来提高标本大小和质量.
- 在前性研究中,冷探针对传统子的诊断优势仍然未被证明.
研究的目的:
- 为了比较1.1毫米冷探针的诊断产量与跨支气管活检的标准子.
- 为了评估冷探针在患有扩散性帕伦基马性肺病,肺病变和肺异位移植的患者中的疗效.
主要方法:
- 一个多中心随机对照试验,比较1.1毫米冷探针和标准.
- 参与者被随机分为1:1,分层分别根据穿 Bronchial 活检的指示.
- 主要结局:通过集中病理学审查判断的适用性和整体诊断产量. 二级结局:组织质量和并发症率.
主要成果:
- 该试验有能力检测到总诊断产量的11.3%的差异,每个手臂有250名参与者.
- 每个指示特定的初级结果的个体功率.
结论:
- 这项试验将为跨支气管活检工具选择提供高质量的证据.
- 结果可能会改变评估扩散性帕伦基马肺病,肺病变和肺异位移植的临床实践.
- 集中病理学审查和务实设计将偏见降至最低,并促进临床整合.
相关概念视频
Clinical Trials
10.8K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
10.8K
Clinical Trials: Overview
5.0K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
5.0K
Statistical Software for Data Analysis and Clinical Trials
1.6K
Statistical software is pivotal in data analysis and clinical trials by providing tools to analyze data, draw conclusions, and make predictions. These software packages range from simple data management applications to complex analytical platforms, supporting various statistical tests, models, and simulation techniques. Their significance lies in their ability to handle vast amounts of data with precision and efficiency, enabling researchers to validate hypotheses, identify trends, and make...
1.6K
Trial and Error and Algorithm
424
A problem-solving strategy is a plan of action used to find a solution. Different strategies have distinct action plans. Trial and error involves trying different solutions until one works. For instance, to fix a broken printer, you might check ink levels, ensure the paper tray isn't jammed, and verify the printer's connection to your laptop. This method can be time-consuming but is commonly used. Thomas Edison, for example, used trial and error to find a suitable filament for the light...
424
Brainstem: Control Centers of Medulla
4.3K
The medulla oblongata is a crucial part of the brainstem responsible for controlling various autonomic and involuntary functions. It contains several nuclei, including the olivary, cuneate, gracile, and solitary nuclei.
Olivary Nucleus
The olivary nucleus, or inferior olivary nucleus, is located within the ventrolateral part of the medulla oblongata. It is primarily involved in motor coordination and motor learning. The olivary nucleus receives input from the spinal cord, cerebellum, and motor...
Olivary Nucleus
The olivary nucleus, or inferior olivary nucleus, is located within the ventrolateral part of the medulla oblongata. It is primarily involved in motor coordination and motor learning. The olivary nucleus receives input from the spinal cord, cerebellum, and motor...
4.3K
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs
250
Body:Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to...
250


