注册号: Registration number: |
ChiCTR2000035492 |
最近更新日期: Date of Last Refreshed on: |
2020-08-12 |
注册时间: Date of Registration: |
2020-08-12 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
程克斌医师:请尽快上传正式版伦理审批文件。 经支气管镜冷冻肺活检联合快速现场评估对弥漫性肺部疾病诊断价值的研究 |
Public title: |
Study on the diagnostic value of transbronchial lung cryobiopsy combined with rapid on-site evaluation for diffuse lung disease |
注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
经软性支气管镜冷冻肺活检联合快速现场评估对弥漫性肺疾病的病因诊断及病理分型价值的研究——一项前瞻性、自身对照的观察性研究 |
Scientific title: |
Study on the value of soft bronchoscopy frozen lung biopsy combined with rapid on-site evaluation in the etiological diagnosis and pathological classification of diffuse lung disease——A prospective, self-controlled observational trial |
研究课题代号(代码): Study subject ID: |
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在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
申请注册联系人: |
程克斌 |
研究负责人: |
程克斌 |
Applicant: |
Kebin Cheng |
Study leader: |
Kebin Cheng |
申请注册联系人电话: Applicant telephone: |
+86 17317556920 |
研究负责人电话: Study leader's telephone: |
+86 13816890251 |
申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
chengkebin2017@163.com |
研究负责人电子邮件: Study leader's E-mail: |
kb.c@163.com |
申请单位网址(自愿提供): Applicant website(voluntary supply): |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
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申请注册联系人通讯地址: |
上海市杨浦区政民路507号 |
研究负责人通讯地址: |
上海市杨浦区政民路507号 |
Applicant address: |
507 Zhengmin Road, Yangpu District, Shanghai, China |
Study leader's address: |
507 Zhengmin Road, Yangpu District, Shanghai, China |
申请注册联系人邮政编码: Applicant postcode: |
研究负责人邮政编码: Study leader's postcode: |
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申请人所在单位: |
上海市肺科医院呼吸与危重症医学科 |
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Applicant's institution: |
Department of Respiratory and Critical Care Medicine,Shanghai Pulmonary Hospital |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
K20-306Y |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
批准本研究的伦理委员会名称: |
上海市肺科医院医学伦理委员会 |
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Name of the ethic committee: |
The Medical Ethics Committee of Shanghai Pulmonary Hospital |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-08-05 | ||
伦理委员会联系人: |
桂涛 |
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Contact Name of the ethic committee: |
Tao Gui |
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伦理委员会联系地址: |
上海市杨浦区政民路507号 |
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Contact Address of the ethic committee: |
507 Zhengmin Road, Yangpu District, Shanghai, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
研究实施负责(组长)单位: |
上海市肺科医院 |
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Primary sponsor: |
Shanghai Pulmonary Hospital |
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研究实施负责(组长)单位地址: |
上海市杨浦区政民路507号 |
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Primary sponsor's address: |
507 Zhengmin Road, Yangpu District, Shanghai, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
自筹 |
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Source(s) of funding: |
self-fianced project |
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研究疾病: |
弥漫性肺疾病 |
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Target disease: |
diffuse lung disease |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
探索性研究/预试验 | ||||||||||||||||||||||
Study phase: |
0 |
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研究目的: |
通过对比经支气管镜冷冻肺活检(TBCB)和常规支气管镜肺活检(TBLB)联合快速现场评估(ROSE)技术在弥漫性肺部疾病诊断中的有效性及安全性,探讨TBCB在DLD诊断中的应用价值。 |
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Objectives of Study: |
To evaluate the efficacy and safety of transbronchial lung cryobiopsy (TBCB) and conventional transbronchial lung biopsy (TBLB) respectively combined with rapid on-site evaluation (ROSE) in the diagnosis of diffuse lung disease (DLD) |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
非随机对照试验 |
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Study design: |
Non randomized control |
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纳入标准: |
a. 诊断不明的DLD成年患者(18岁-75岁),且因病情需要行经支气管冷冻活检者; b. 入院患者需完成动脉血气分析、血常规、血凝常规、肝肾功能、心电图、免疫学检查、胸部HRCT等检查; c.依从性好,能配合本研究观察; d. 充分告知试验目的、方法,愿意参加本研究并签署知情同意书。 |
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Inclusion criteria |
1. Adult patients aged 18 to 75 years with suspected diagnosis of DLD who require transbronchial lung cryobiopsy; 2. Admitted patients need to complete arterial blood gas analysis, blood routine, blood coagulation routine, liver and kidney function, electrocardiogram, immunological examination, chest HRCT and other examinations; 3. The patients have Good compliance,are able to cooperate with this research observation; 4. Fully inform the purpose and method of the experiment, willing to participate in the study and sign the informed consent. |
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排除标准: |
a.不同意参加本研究; b.参加其他研究,影响本研究观察; c.术前未能配合完成入院要求完成的检查者; d.胸部HRCT表现为非间质性肺疾病者; e.研究者认为有任何不适合入选情况者; |
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Exclusion criteria: |
1. Disagree to participate in this study; 2. Join in other studies, which will affect the observation of this study; 3. Those who fail to cooperate with the completion of the examinations required for admission before bronchoscopy; 4. Those with chest HRCT showing non-interstitial lung disease; 5. The researchers consider that there is any situation that is not suitable for selection. |
研究实施时间: Study execute time: |
从From2020-10-01至To 2023-09-30 |
征募观察对象时间: Recruiting time: |
从From2020-10-01至To 2023-09-30 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
无 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
N/A |
盲法: |
N/A |
Blinding: |
N/A |
试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
是Yes |
共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址): |
公开原始数据的时间是在试验完成后6个月内,采用EDC系统ResMan平台,网址为http://medresman.org.cn |
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
The time of sharing IPD will be within six months after the trial complete. The public database Resman(http://medresman.org.cn)will applied. |
数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC: |
数据收集将采用病例记录表,数据管理将使用ResMan平台 |
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Case Record Form will be utilized for data collection. ResMan will be applied for electronic data capture. |
数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |