简体中文|English
检索试验 按国家、省（市）统计 按疾病代码统计 按试验实施单位统计 按试验主办单位统计 按经费或物资来源统计 按征募研究对象情况统计 按注册状态统计 按干预措施统计 按伦理委员会统计 按研究类型统计
全息影像三维可视化模型应用于经皮肾镜碎石取石术前规划和术中引导的临床研究
下载XML文档

注册号：

Registration number：

 ChiCTR2100053225 

最近更新日期：

Date of Last Refreshed on：

 2022-09-13 05:11:21 

注册时间：

Date of Registration：

 2021-11-16 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

全息影像三维可视化模型应用于经皮肾镜碎石取石术前规划和术中引导的临床研究

Public title：

Application of holographic three-dimensional visualization model in preoperative planning and intraoperative guidance of percutaneous nephrolithotomy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

泌尿外科全息影像辅助手术系统的研发

Scientific title：

Research and development of holographic image assisted surgery system in urology

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：

汪磊 

研究负责人：

李宁忱 

Applicant：

Wang Lei 

Study leader：

Li Ningchen 

申请注册联系人电话：

Applicant telephone：

 +86 15101184209

研究负责人电话：

Study leader's
telephone：

+86 13910708351

申请注册联系人传真 ：

Applicant Fax：

 +86 10 57830131

研究负责人传真：

Study leader's fax：

 +86 10 57830131

申请注册联系人电子邮件：

Applicant E-mail：

 wanglei_09243633@163.com

研究负责人电子邮件：

Study leader's E-mail：

 ningchenli@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 http://www.sgyy.com.cn/

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 http://www.sgyy.com.cn/

申请注册联系人通讯地址：

北京市石景山区晋元庄路9号

研究负责人通讯地址：

北京市石景山区晋元庄路9号

Applicant address：

9 Jinyuanzhuang Road, Shijingshan District, Beijing

Study leader's address：

9 Jinyuanzhuang Road, Shijingshan District, Beijing

申请注册联系人邮政编码：

Applicant postcode：

 100144

研究负责人邮政编码：

Study leader's postcode：

 100144

申请人所在单位：

北京大学首钢医院

Applicant's institution：

Peking Uniersity Shougang Hospital

研究负责人所在单位：

北京大学首钢医院

Affiliation of the Leader：

Peking Uniersity Shougang Hospital

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：

 IRB-AF-25-02

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：

北京大学首钢医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Peking University Shougang Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-12-06 00:00:00

伦理委员会联系人：

李红娟

Contact Name of the ethic committee：

Li Hongjuan

伦理委员会联系地址：

北京市石景山区晋元庄路9号北京大学首钢医院科研处

Contact Address of the ethic committee：

Department of Scientific Research, Peking University Shougang Hospital, 9 Jinyuanzhuang Road, Shijingshan District, Beijing

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：

 ethics_sgyy@163.com

研究实施负责（组长）单位：

北京大学首钢医院泌尿外科

Primary sponsor：

Department of Urology, Peking University Shougang Hospital

研究实施负责（组长）单位地址：

北京市石景山区晋元庄路9号

Primary sponsor's address：

9 Jinyuanzhuang Road, Shijingshan District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

石景山区

Country：

China

Province：

Beijing

City：

Shijingshan District

单位(医院)：

北京大学首钢医院

具体地址：

晋元庄路9号

Institution
hospital：

Peking University Shougang Hospital

Address：

9 Jinyuanzhuang Road

经费或物资来源：

北京大学首钢医院2019临床重点建设项目

Source(s) of funding：

2019 clinical key construction project of Peking University Shougang Hospital

研究疾病：

肾结石  

Target disease：

Nephroliothasis

研究疾病代码：

GB70.0

Target disease code：

GB70.0

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

建立经皮肾镜碎石取石术的全息影像三维可视化模型，在混合现实环境下指导术中穿刺，评价其准确性和临床价值。  

Objectives of Study：

To establish a holographic 3D visualization model of percutaneous nephrolithotomy (PCNL), apply it to guiding intraoperative puncture in a mixed reality environment, and evaluate its accuracy and clinical value.

药物成份或治疗方案详述：

1.患者分组 在我中心诊治的具有PCNL手术指征和手术意愿的尿路结石患者，随机分为常规PCNL手术组（对照组）和全息3D影像引导手术组（简称全息组）。其中对照组术前行平卧位CT检查，术中取俯卧位手术。全息组于俯卧位下行CT检查，术前制作全息模型并于术中行全息引导下穿刺及手术。 2.计算机断层扫描（3D组） 术前行泌尿系增强CT检查（含排泄期）。将5片心电图电极片贴在腰背部皮肤作为位置标记，并保留至术中。CT扫描时患者取俯卧位，胸部和腹部垫手术用体位垫。患者被要求在平静吸气末屏住呼吸。采用Philips（荷兰阿姆斯特丹）64排双能CT扫描，扫描厚度为1毫米。 3.全息3D可视化模型的构建和手术规划 获取患者CT数据（DICOM格式），通过Mimics软件（比利时鲁汶Materialise Corp.）分割手术相关器官和结构，包括骨骼、皮肤标记贴、集合系统等。基于三维模型确定目标肾盏并规划穿刺路径。该路径尽量通过目标肾盏的长轴，规避叶间小动脉和邻近器官，并要求具有良好的清石角度。通过该三维模型对PCNL手术过程进行模拟，预测通过目标盏的视野和盲区，估计碎石效果及可能的残留结石。对集合系统的3D模型进行模拟“截面切割”，获取模拟超声图像，以协助术中B超快速准确识别目标肾盏。 4.术中视觉配准及全息引导穿刺 a.手术准备：患者行全身麻醉，先取截石位，逆行置入输尿管导管（虎尾管）行常规人工肾积水，并备逆行造影（碘海醇）。之后患者改为俯卧位，胸腹部下方垫体位垫（同CT摄片）。 b.全息投影与初步视觉配准：术前将PCNL 3D可视化模型（含目标肾盏背部皮肤投影点）输入到第二代头戴式增强现实设备（HoloLens Glass，Microsoft，USA）。术者佩戴HoloLens眼镜，调整3D模型的大小和位置，并根据“皮肤定位贴”使其与真实人体（俯卧位）进行视觉配准，在背部皮肤上标记虚拟的目标肾盏皮肤投影点。之后常规行术区消毒，连接水泵、肾镜/硬质输尿管镜、视频装置等。 c.B超及X线透视目标盏及偏差计算 初步配准完毕后，经输尿管导管逆行注入显影剂，使集合系统显影。此时麻醉师配合，予以一500ml吸气量后停止呼气，使肾脏随呼吸的移动消失。B超及X线透视判定目标盏，并于背部皮肤标记实际的目标肾盏皮肤投影点。计算实际投影点与虚拟投影点的偏差。 d.呼吸条件优化及偏差纠正 通过调整吸气量（通过预实验证实一般为增加吸气量）使得肾脏下移，至目标肾盏的实际投影点与虚拟投影点完全吻合。术前需通过肺功能了解患者的最大吸气量，使得吸气量在安全的区间。 e.数据记录及呼吸条件建模 记录配准偏差的大小，纠正该偏差所需要的补充吸气量，患者BMI指数、肺功能参数等，建立数学模型，预估达到无偏差配准所需要的呼吸条件。 经皮肾穿刺术中导航 f.完成上述无偏差视觉配准后，按虚拟穿刺引导线指示的皮肤穿刺点、穿刺角度、穿刺深度进针，该过程仍由B超及X线透视下监视。穿刺准确的术中评估：穿刺到位，拔除针芯后可见尿液流出，并且术中B超/X线透视提示穿刺针准确进入目标盏；穿刺准确的术后评估：术后保留肾造瘘管，行CT平扫并进行三维建模，根据造瘘管进入目标盏的准确性和角度对术中穿刺准确与否进行二次评判。 5. 数据和问卷 记录每位患者的临床特征和手术资料，包括年龄、性别、BMI、结石体积、配准时间、穿刺时间、穿刺尝试次数、手术时间、血色素下降、结石清除率、输血率和严重并发症等（包括介入栓塞、邻近器官损伤和感染性休克）。术后通过CT扫描评估结石清除率和PCN通道的符合率。彻底清石定义为没有直径大于4mm的结石碎片残留。PCN通道的符合率定义为CT显示肾造瘘管通过目标肾盏进入集合系统。穿刺时间包括B超扫描和经皮肾穿刺的时间，全息组也包含与“模拟超声图像”比较的时间，但需排除测量肾脏偏差的时间。 设计主观问卷，了解外科医生在术前计划和术中应用三维可视化模型方面的满意度。 

Description for medicine or protocol of treatment in detail：

1.Patients grouping Patients with urinary calculi with PCNL indications and willingness to operate in our center were divided into routine PCNL operation group (routine group) and holographic 3D image-guided operation group (3D group). The routine group underwent CT examination in the supine position before operation, and the prone position was taken during operation. 3D group underwent CT examination in prone position, holographic model making, intraoperative holographic guided puncture and operation. 2.Computed Tomography An enhanced CT including excretory phase was performed before operation. Five pieces of electrocardiogram (ECG)?electrode?patch were pasted on the skin around the waist and back as position markers, and retained until operation. During CT scanning, the patient was placed in the prone position, and the chest and abdominal pads were placed in the same position as during the operation. The patients were asked to hold their breath at the end of a calm inhalation. Philips (Amsterdam, the Netherlands) 64 row dual energy CT scanning was employed, and the scanning thickness was one millimeter. 3.3-D visualization model and preoperative planning Patients’ CT data in DICOM format were obtained, all relevant organs and structures, including bones, position markers, collecting systems, etc, could be segmented by Mimics software (Materialise Corp., Leuven, Belgium). Based on the 3D model, target calyces were determined by experienced surgeons on our team, and planned puncture routes were also designed and marked in the model. The route passed through the axis of the targeted renal calyx, avoiding major blood vessels and adjacent organs, and obtained a good angle for stone clearance. With the 3D model, the process of PCNL could be simulated virtually, the visual field and blind area through targeted calyces could be speculated, and the effect of lithotripsy as well as possible residual stones could be estimated. To help identify the targeted calyx accurately during B-ultrasound guided renal puncture, a simulation of ultrasound image was performed by obtaining an optimal section by segmenting the collection system in the 3D model. 4.Intraoperative application Before surgery, segmented organs, tissues and puncture routes in the 3D model were marked in desired colors and transparency and then input to the second generation of head worn augmented reality device (HoloLens glasses, Microsoft, USA). During the operation, the patient was given general anesthesia. A ureteral catheter was placed in the lithotomy position, and artificial hydronephrosis was performed. Afterwards, the patient was placed in the same prone position, and the chest and abdomen were padded with the same cushions as those in CT scanning. The operator wore HoloLens glasses (Microsoft, the U.S.A), adjusted the size and position of the 3D model, and made it register properly with the human body based on the "positioning markers". Then, the operation area was disinfected, and routine preparation steps were performed. After registration, the position deviation of the real kidney under anesthesia still needed to be considered. The real position of the targeted calyx or lowest pole of the kidney at the end of ventilator blowing was determined through B-ultrasound scanning. Afterwards, the position deviation between the real and the virtual kidneys (represented by lowest pole of kidney) was calculated. According to the distance of kidney deviation, three different puncture strategies were used: 1) no or minor deviation (≤2 mm): puncture based on the planned point and angle in the 3D model; 2) medium deviation (2-6 mm): puncture with the planned point but the puncture angle was adjusted; 3) major deviation (>6 mm): the planned point was adjusted accordingly. All punctures were carried out under the guidance of conventional ultrasound, while the planned puncture point and angle in the virtual 3D model were used for reference and comparison. After a successful puncture, the puncture channel was gradually expanded to F16-F20, and holmium laser lithotripsy was then performed routinely. 5.Data and Questionnaire The clinical characteristics and operation data of each patient were recorded, including age, sex, BMI, stone volume, registration time, puncturing time, puncturing attempts, number of percutaneous renal accesses, operation time, hemoglobin loss, stone clearance rate, blood transfusion rate, and severe complications; including interventional embolization, adjacent organ injury, and septic shock. The stone clearance and coincidence rates of the PCN channel were evaluated by CT scans after the operation. Complete stone clearance was defined as the absence of stone fragments with a diameter greater than 4 mm. The coincidence between the planned and actual channels was defined as the actual channel passing through the planned target calyx (Figure 2C-D). Puncture time indicates the time of B-ultrasound scanning and percutaneous renal puncture, while in the 3D model group, it also included the time of comparison with the “simulated ultrasound image”. However, the time for measurement of kidney deviation was excluded. For cases with more than one channel, it means a total puncturing time for the two or more channels. A subjective questionnaire was designed to understand the degree of satisfaction of surgeons both in preoperative planning and intraoperative application of the 3D visualization model.  

纳入标准：

Inclusion criteria

排除标准：

1.未按特定要求（俯卧位、使用定位标记等）进行CT检查者；
2.沟通障碍或身体障碍不能接受经皮肾穿刺及碎石术。

Exclusion criteria：

1. Those who did not undergo CT examination according to specific requirements (prone position, positioning marker used, etc.);
2. Communication disorders or physical disorders cannot be matched with percutaneous renal puncture.

研究实施时间：

Study execute time：

从 From 2020-10-01 00:00:00至 To 2023-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-10-01 00:00:00 至 To 2022-09-30 00:00:00

干预措施：

Interventions：

组别：

全息3D影像引导手术组

样本量：

 50

Group：

Holographic 3D image guided PCNL group

Sample size：

干预措施：

全息模型术前规划及术中引导经皮肾穿刺

干预措施代码：

Intervention：

Preoperative planning and intraoperative guidance of percutaneous renal puncture using holographic model

Intervention code：

组别：

常规PCNL手术组

样本量：

 100

Group：

Routine PCNL operation group

Sample size：

干预措施：

常规俯卧位下超声或X线引导的PCNL术

干预措施代码：

Intervention：

Routine PCNL operation guided by ultrasound or X-ray in prone position

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

 石景山区 

Country：

China

Province：

Beijing

City：

Shijingshan District

单位(医院)：

 北京大学首钢医院 

单位级别：

 三级教学医院 

Institution
hospital：

Peking University Shougang Hospital

Level of the institution：

Tertiary teaching hospital

测量指标：

Outcomes：

指标中文名：

配准时间

指标类型：

次要指标

Outcome：

Registation time

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

穿刺时间

指标类型：

主要指标

Outcome：

Puncture time

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

手术总时间

指标类型：

次要指标

Outcome：

Total operation time

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

穿刺尝试次数

指标类型：

主要指标

Outcome：

Number of puncture attempts

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血色素下降

指标类型：

次要指标

Outcome：

hemoglobin loss

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

清石率

指标类型：

次要指标

Outcome：

stone clearance rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

输血率

指标类型：

次要指标

Outcome：

blood transfusion rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

严重并发症率

指标类型：

次要指标

Outcome：

severe complication rate

Type：

Secondary 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：

患者临床资料和手术相关数据

组织：

无组织

Sample Name：

clinical data

Tissue：

no sample needed

人体标本去向

 使用后保存  

说明

长久保存相关数据

Fate of sample：

Preservation after use  

Note：

longterm preservation

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 18 岁 years
最大 Max age 90 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）：

随机数字表法

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

Random number table method

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：

不对患者及研究者设盲，但对统计人员设盲。

Blinding：

Patients and researchers are not blinded, but statisticians are blinded.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

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）：

不共享 请阅读网页注册指南中关于 原始数据共享 的内容。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

No sharing

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：

病例记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case Record Form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-11-16 21:01:56
返回列表
欢迎访问WHO国际临床试验注册平台 Clinical Trials Hong Kong

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

Copyright(c) (2005 - 2023) Chictr.org.cn.All rights reserved. 中国临床试验注册中心 版权所有

蜀ICP备16010396号-9

提示：推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统