中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500100191
最近更新日期： Date of Last Refreshed on：	2025-04-03 15:30:01
注册时间： Date of Registration：	2025-04-03 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	在体共聚焦激光内窥镜成像技术在肺移植术后闭塞性细支气管炎综合征中的临床研究
Public title：	Clinical study of in vivo confocal laser endoscopy in bronchiolitis obliterians syndrome after lung transplantation
注册题目简写：
English Acronym：
研究课题的正式科学名称：	在体共聚焦激光内窥镜成像技术在肺移植术后闭塞性细支气管炎综合征中的临床研究
Scientific title：	Clinical study of in vivo confocal laser endoscopy in bronchiolitis obliterians syndrome after lung transplantation
研究课题代号(代码)： Study subject ID：
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：	刘天洋	研究负责人：	吴波
Applicant：	Tianyang Liu	Study leader：	Bo Wu
申请注册联系人电话： Applicant telephone：	+86 187 6236 0321	研究负责人电话： Study leader's telephone：	+86 158 5275 9830
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	Rachel_lty@163.com	研究负责人电子邮件： Study leader's E-mail：	15852759830@126.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)：
申请注册联系人通讯地址：	江苏省无锡市梁溪区清扬路299号	研究负责人通讯地址：	江苏省无锡市梁溪区清扬路299号
Applicant address：	299 Qingyang Road, Liangxi District, Wuxi City, Jiangsu Province	Study leader's address：	299 Qingyang Road, Liangxi District, Wuxi City, Jiangsu Province
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：
申请人所在单位：	无锡市人民医院
Applicant's institution：	Wuxi People’s Hospital Affiliated to Nanjing Medical
研究负责人所在单位：	无锡市人民医院
Affiliation of the Leader：	Wuxi People’s Hospital Affiliated to Nanjing Medical

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	(2023) 科研伦审第(KY23010)号	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：	无锡市人民医院科研伦理委员会
Name of the ethic committee：	Research Ethics Committee of Wuxi People’s Hospital Affiliated to Nanjing Medical
伦理委员会批准日期： Date of approved by ethic committee：	2023-01-30 00:00:00
伦理委员会联系人：	陆培华
Contact Name of the ethic committee：	Peihua Lu
伦理委员会联系地址：	江苏省无锡市梁溪区清扬路299号
Contact Address of the ethic committee：	299 Qingyang Road, Liangxi District, Wuxi City, Jiangsu Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 136 2150 0031	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：

无锡市人民医院

Primary sponsor：

Wuxi People’s Hospital Affiliated to Nanjing Medical

研究实施负责（组长）单位地址：

江苏省无锡市梁溪区清扬路299号

Primary sponsor's address：

299 Qingyang Road, Liangxi District, Wuxi City, Jiangsu Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	江苏	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	无锡市人民医院	具体地址：	江苏省无锡市梁溪区清扬路299号
Institution hospital：	Wuxi People’s Hospital Affiliated to Nanjing Medical	Address：	299 Qingyang Road, Liangxi District, Wuxi City, Jiangsu Province

经费或物资来源：

无锡市卫生健康委员会

Source(s) of funding：

Wuxi Municipal Health Commission

研究疾病：

肺移植术后慢性肺移植功能障碍

Target disease：

Bronchiolitis obliterans after lung transplantation

研究疾病代码：

Target disease code：

研究类型：

诊断试验

Study type：

Diagnostic test

研究所处阶段：

其它

Study phase：

N/A

研究设计：

诊断试验诊断准确性

Study design：

Diagnostic test for accuracy

研究目的：

慢性肺移植功能障碍（CLAD）是限制肺移植受者远期生存的主要因素，约有一半的肺移植受者在移植后5年内发生CLAD。闭塞性细支气管炎综合征（BOS）是慢性肺移植功能障碍的主要表现形式。经支气管镜肺活检是BOS组织学诊断的基本方法，但其敏感度低、创伤风险高，无法常规周期性实施。共聚焦激光内窥镜（CLE）作为一种新型成像工具，与传统活检组织病理学诊断相比，具有实时、无创、高敏感性及特异性等特性。本课题通过纳入符合标准的肺移植术后拟诊断BOS受者队列及确定肺移植术后BOS诊断金标准，将肺移植受者分成BOS组与对照组，应用基于CLE的在体共聚焦显微成像技术获取影像学数据，经统计分析筛选出有统计学差异的数据类型，并通过ROC曲线评估诊断界值诊断效能，进而建立最佳CLE下BOS诊断标准，明确其灵敏度、特异度、阴性预测值、阳性预测值、真阳性率、真阴性率、假阳性率、假阴性率，从而针对现有临床局限性，建立一种无创、快速精准诊断肺移植后BOS的新诊断方式。

Objectives of Study：

Chronic lung transplant dysfunction (CLAD) is the main factor limiting the long-term survival of lung transplant recipients, with approximately half of lung transplant recipients developing CLAD within 5 years after transplantation. Bronchiolitis obliterans syndrome (BOS) is the main manifestation of chronic lung transplant dysfunction. Bronchoscopy lung biopsy is the basic method for histological diagnosis of BOS, but it has low sensitivity and high trauma risk, and cannot be routinely performed periodically. As a new imaging tool, confocal laser endoscopy (CLE) has the characteristics of real-time, non-invasive, high sensitivity, and specificity compared to traditional biopsy tissue pathology diagnosis. This study included a queue of lung transplant recipients who met the criteria for BOS diagnosis and determined the gold standard for BOS diagnosis after lung transplantation. The lung transplant recipients were divided into a BOS group and a control group, and imaging data was obtained using in vivo confocal microscopy imaging technology based on CLE. Statistical analysis was performed to screen for data types with statistical differences, and ROC curves were used to evaluate the diagnostic performance of the diagnostic threshold. The optimal diagnostic criteria for BOS under CLE were established, and their sensitivity, specificity, negative predictive value, positive predictive value, true positive rate, true negative rate, false positive rate, and false negative rate were clarified. In order to address the existing clinical limitations, a new non-invasive, rapid, and accurate diagnosis method for BOS after lung transplantation was developed. Diagnostic method.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

（1）生命体征不平稳；（2）意识障碍，脑血管意外、脑卒中；（3）脓毒症休克/ARDS；（4）急性冠脉综合征；（5）近期有大咯血；（6）严重出血倾向；（7）吸烟；（8）肺功能严重受损，伴有严重的低氧血症，无法耐受支气管镜检查。

Exclusion criteria：

(1) Unstable vital signs; (2) Consciousness disorders, cerebrovascular accidents, stroke; (3) Septic shock/ARDS; (4) Acute coronary syndrome; (5) Recently, there has been severe hemoptysis; (6) Severe bleeding tendency; (7) Smoking; (8) Severe impairment of lung function, accompanied by severe hypoxemia, and inability to tolerate bronchoscopy examination.

研究实施时间：

Study execute time：

从 From 2023-09-12 00:00:00至 To 2025-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2023-09-12 00:00:00 至 To 2025-12-31 00:00:00

诊断试验：

Diagnostic Tests：

金标准或参考标准（即可准确诊断某疾病的单项方法或多项联合方法，在本研究中用于诊断是否有该病的临床参考标准）：	根据2007年ISHLT发布的闭塞性细支气管炎组织病理学诊断标准：呼吸性细支气管黏膜下层致密嗜酸性透明质纤维化，气道壁的平滑肌和黏膜碎裂及破坏，可延伸至支气管周围肺间质，部分或完全细支气管管腔阻塞，呈同心或偏心状。对TBLB组织，由两名病理科医师独立阅片进行组织病理学诊断诊断。
Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):	According to the histopathological diagnostic criteria for bronchiolitis obliterans published by ISHLT in 2007, respiratory bronchiolitis is characterized by dense eosinophilic fibrosis of the submucosal layer, smooth muscle and mucosal fragmentation and destruction of the airway wall, which can extend to the interstitial space around the bronchi, partial or complete obstruction of the bronchioles, and concentric or eccentric shapes. For TBLB tissue, two pathologists independently reviewed the images for histopathological diagnosis.
指标试验（即本研究的待评估诊断试验，无论为方法、生物标志物或设备，均请列出名称）：	在pCLE下对图像数据进行形态学测量和评估，收集定量数据，包括每个显微镜视野的中值细胞计数、细胞自发荧光单位、细胞自发发光比率和呼吸细支气管直径
Index test:	Morphological measurement and evaluation of image data under pCLE, collecting quantitative data including median cell count per microscopic field, cell spontaneous fluorescence units, cell spontaneous fluorescence ratio, and respiratory bronchiolar diameter
目标人群（可以是某种疾病患者或正常人群，详细描述其疾病特征，注意应纳入符合分布特点的全序列病例，具有良好的代表性）	肺移植受者第1秒用力呼气容积（forced expiratory volume in one second，FEV1）相对基线值显著且持续下降>=20%，同时受者 FEV1/用力肺活量（Forced vital capacity，FVC）<70%，且没有影像学上的浑浊表现时的病人	例数: Sample size: 100
Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):	When the forced expiratory volume in one second (FEV1) of lung transplant recipients is significantly and continuously decreased by >= 20% compared to baseline, and the FEV1/forced vital capacity (FVC) ratio of recipients is less than 70% without imaging turbidity
容易混淆的疾病人群（即与目标疾病不易区分的一种或多种不同疾病，应避免采用正常人群对照的病例-对照设计）：	感染、急性排异、机化性肺炎的病人	例数: Sample size: 0
Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:	Patients with infection, acute rejection, and organizing pneumonia

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	江苏	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	无锡市人民医院	单位级别：	三甲
Institution hospital：	Wuxi People’s Hospital Affiliated to Nanjing Medical	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	每微观视野下细胞计数中位数	指标类型：	主要指标
Outcome：	Median cell count per microscopic field of view	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	呼吸性细支气管直径	指标类型：	主要指标
Outcome：	Diameter of respiratory bronchioles	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	肺组织	组织：
Sample Name：	Lung tissue	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age		岁 years
最大 Max age		岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

所有pCLE操作过程患者均是匿名的，随机进入气管镜室，由两位经验丰富的具有高级职称医师操作，他们对所有临床信息一无所知。后续将有2名专业统计人员收集病理结果，独立审查pCLE图像，并记录相关数据。操作者与统计者均匿名互盲。

Randomization Procedure (please state who generates the random number sequence and by what method)：

All patients undergoing pCLE procedures are anonymous and randomly assigned to the bronchoscopy room, operated by two experienced physicians with senior professional titles who have no knowledge of any clinical information. Two professional statisticians will collect pathological results, independently review pCLE images, and record relevant data in the future. Both the operator and the statistician are anonymous and mutually blinded.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	采用网络平台于试验结束6个月后上传至http://www.medresman.org.cn/login.aspx
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	After finishing the research, the data will be uploaded to the website within 6 months: http://www.medresman.org.cn/login.aspx
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：	由专人负责数据采集制定病历数据记录表，试验结束后6个月上传临床试验公共管理平台。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	A specially assigned person is responsible for data collection and preparation of the medical record data record form, which is uploaded to the clinical trial public management platform 6 months after the end of the trial.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2025-04-03 15:29:52