ChiCTR2500115124 版本V1.0 版本创建时间2025/12/23 09:01:49 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500115124 

最近更新日期：

Date of Last Refreshed on：

 2025-12-23 09:01:31 

注册时间：

Date of Registration：

 2025-12-23 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

聚多卡醇不同注射方法治疗儿童化脓性肉芽肿疗效与安全性的前瞻性、随机、对照临床试验

Public title：

Efficacy and Safety of Different Polidocanol Injection Methods for Pediatric Pyogenic Granuloma: A Prospective Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

聚多卡醇硬化治疗肉芽肿血管瘤的研究

Scientific title：

Study on Polidocanol Sclerotherapy for Pyogenic Granuloma

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：

刘欣雨 

研究负责人：

郭磊 

Applicant：

Liu Xinyu 

Study leader：

Guo Lei 

申请注册联系人电话：

Applicant telephone：

 +86 185 6717 3815

研究负责人电话：

Study leader's
telephone：

+86 136 9862 9521

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：

 3087044596@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 etjrxgl@vip.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)：

申请注册联系人通讯地址：

山东省济南市槐荫区经十路23976号

研究负责人通讯地址：

山东省济南市槐荫区经十路23976号

Applicant address：

No. 23976, Jingshi Road, Huaing District, Jinan City, Shandong Province

Study leader's address：

No. 23976, Jingshi Road, Huaing District, Jinan City, Shandong 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：

济南市儿童医院

Applicant's institution：

Jinan Children's Hospital

研究负责人所在单位：

济南市儿童医院

Affiliation of the Leader：

Jinan Children's 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：

 SDFE-IRB/P-2025013

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：

济南市儿童医院伦理委员会

Name of the ethic committee：

The Ethics Committee of Jinan Children's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-11-13 00:00:00

伦理委员会联系人：

李春苗

Contact Name of the ethic committee：

Li Chunmiao

伦理委员会联系地址：

山东省济南市槐荫区经十路23976号

Contact Address of the ethic committee：

No. 23976, Jingshi Road, Huaing District, Jinan City, Shandong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 188 6611 5863

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：

济南市儿童医院

Primary sponsor：

Jinan Children's Hospital

研究实施负责（组长）单位地址：

山东省济南市槐荫区经十路23976号

Primary sponsor's address：

No. 23976, Jingshi Road, Huaing District, Jinan City, Shandong 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)：

山东省

市(区县)：

济南市

Country：

China

Province：

Shandong

City：

Jinan

单位(医院)：

济南市儿童医院

具体地址：

山东省济南市槐荫区经十路23976号

Institution
hospital：

Jinan Children's Hospital

Address：

No. 23976, Jingshi Road, Huaing District, Jinan City, Shandong Province

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

化脓性肉芽肿  

Target disease：

Pyogenic Granuloma

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究旨在通过一项前瞻性随机对照试验，系统比较“瘤体基底部复合注射法”与“瘤体部注射法”在治疗儿童化脓性肉芽肿（Pyogenic Granuloma，PG）中的疗效与安全性，为临床优化硬化剂注射方法提供高级别循证依据。  

Objectives of Study：

This study aims to systematically compare the efficacy and safety of 'compound injection at the tumor base' versus 'intratumoral injection' in the treatment of pediatric pyogenic granuloma (PG) through a prospective randomized controlled trial. The findings are intended to provide high-level evidence for optimizing clinical sclerotherapy injection techniques.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

（1）年龄大于三个月，性别不限； （2）符合PG的典型临床诊断标准，并经彩色多普勒超声确诊； （3）皮损的最大直径为5mm-15mm； （4）既往未接受过针对该皮损的手术切除、激光、冷冻或硬化治疗等； （5）肝、肾功能及凝血功能检查无明显异常； （6）患儿监护人充分理解研究内容，并签署书面知情同意书。

Inclusion criteria

1.Age > 3 months, regardless of gender; 2.Met the typical clinical diagnostic criteria for PG, confirmed by color Doppler ultrasound; 3.Maximum lesion diameter ranging from 5 mm to 15 mm; 4.No prior treatment (such as surgical excision, laser therapy, cryotherapy, or sclerotherapy) for the target lesion; 5.No significant abnormalities in hepatic, renal, or coagulation functions; 6.Guardians fully understood the study protocols and signed the written informed consent form.

排除标准：

（1）对研究药物（聚多卡醇、利多卡因）任一成分过敏者； （2）合并严重的心、肺、肝、肾或血液系统疾病； （3）免疫功能缺陷或正在接受免疫抑制剂治疗； （4）皮损部位存在活动性感染； （5）监护人依从性差，预计难以完成后续随访。

Exclusion criteria：

1.Known hypersensitivity or allergy to any component of the study drugs (polidocanol or lidocaine); 2.Concurrent severe cardiac, pulmonary, hepatic, renal, or hematological diseases; 3.Immunodeficiency or current use of immunosuppressive therapy; 4.Active infection at the lesion site; 5.Poor compliance of guardians, with an anticipated inability to complete the scheduled follow-up.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2028-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-01-01 00:00:00 至 To 2026-06-30 00:00:00

干预措施：

Interventions：

组别：

A组（瘤体部注射组）

样本量：

 32

Group：

Group A (Intratumoral Injection Group)

Sample size：

干预措施：

进针点选择：于瘤体正上方或侧方体表投影处垂直进针。 穿刺与注射路径：针尖穿刺至瘤体核心。若瘤体体积较大，可根据其形态，通过调整针尖方向进行瘤体内多点注射，以确保药物在瘤体实质内均匀弥散。 核心注射与终点判断：缓慢推注硬化剂，直至瘤体整体颜色转为苍白、形态饱满并呈现适度张力。维持此苍白状态约10秒。若在此期间瘤体颜色恢复，则补充注射至苍白状态再次出现。 剂量控制：单次治疗总剂量原则上不超过0.5ml。若注射过程中出现药液自瘤体表面渗漏，可酌情适当增加注射剂量。

干预措施代码：

Intervention：

Needle Entry Point: The needle was inserted vertically at the skin surface projection, either directly above or lateral to the tumor. Puncture and Injection Path: The needle tip was advanced to the core of the lesion. For larger lesions, the direction of the needle tip was adjusted based on the lesion's morphology to perform multi-point intratumoral injections, ensuring uniform diffusion of the drug within the lesion parenchyma. Injection and Endpoint Determination: The sclerosing agent was injected slowly until the entire lesion turned pale, appeared filled, and exhibited moderate tension. This blanching was maintained for approximately 10 seconds. If the color of the lesion reverted during this period, a supplemental injection was administered until the blanching reappeared. Dose Control: In principle, the total dose per session did not exceed 0.5 ml. However, if leakage of the solution from the lesion surface occurred during the injection, the dose was increased appropriately.

Intervention code：

组别：

B组（瘤体基底部复合注射组）

样本量：

 32

Group：

Group B (Compound Basal Injection Group)

Sample size：

干预措施：

进针点选择：于距离瘤体边缘约2mm的正常组织处进针。 穿刺与注射路径：针尖斜行进针，穿越皮下组织后抵达并进入瘤体核心。同样地，可根据瘤体大小行单点或多点注射。 核心注射与终点判断：缓慢推注大部分预设剂量的硬化剂，直至瘤体整体颜色转为苍白并呈现适度张力。维持此苍白状态约10秒。若颜色恢复，则补充注射至苍白状态再次出现。 基底部封闭注射：完成瘤体内注射后，将穿刺针回撤至瘤体基底部层面，变换方向，于基底部行扇形浸润注射，推注少量剩余药物，以期封闭基底部的滋养血管。 剂量控制：单次治疗总剂量原则上不超过0.5ml。若因穿刺导致瘤体破溃出血而影响药物存留，可酌情适当增加注射剂量。

干预措施代码：

Intervention：

Needle Entry Point: The needle was inserted through normal tissue approximately 2 mm from the margin of the lesion. Puncture and Injection Path: The needle was advanced obliquely through the subcutaneous tissue to reach and enter the core of the lesion. Similarly, single-point or multi-point injections were performed depending on the size of the lesion. Core Injection and Endpoint Determination: The majority of the predetermined dose of sclerosing agent was injected slowly until the entire lesion turned pale and exhibited moderate tension. This blanching was maintained for approximately 10 seconds. If the color reverted, a supplemental injection was administered until blanching reappeared. Basal Sealing Injection: After the intratumoral injection was completed, the needle was withdrawn to the level of the lesion base. The needle direction was then redirected to perform a fan-shaped infiltration injection at the base, delivering the small amount of remaining drug to seal the feeding vessels. Dose Control: In principle, the total dose per session did not exceed 0.5 ml. However, if the lesion ruptured or bled due to the puncture, thereby affecting drug retention, the dose was increased appropriately.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东 

市(区县)：

  

Country：

China

Province：

ShanDong

City：

单位(医院)：

 济南市儿童医院 

单位级别：

 三甲 

Institution
hospital：

Jinan Children's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

首次治疗后第4周的痊愈率

指标类型：

主要指标

Outcome：

Cure rate at 4 weeks after the initial treatment

Type：

Primary indicator

测量时间点：

首次治疗后第4周

测量方法：

痊愈标准：皮损体积100%消退，无出血，彩色多普勒超声显示无血流信号

Measure time point of outcome：

4 weeks after the initial treatment

Measure method：

Criteria for Cure: Defined as 100% regression of the lesion volume, absence of bleeding, and no blood flow signals detected by color Doppler ultrasound.

指标中文名：

达到痊愈所需治疗次数

指标类型：

次要指标

Outcome：

Number of treatment sessions required for cure

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

瘢痕程度

指标类型：

次要指标

Outcome：

Degree of scarring

Type：

Secondary indicator

测量时间点：

末次治疗后第12周

测量方法：

0级：皮肤平整，可见纹理，质地柔软，无色差； +级：皮肤轻微凹凸或色素改变，纹理欠佳，质地稍硬； ++级：皮肤凹凸较明显，纹理消失，质地较硬； +++级：出现增生性瘢痕。

Measure time point of outcome：

12 weeks after the final treatment

Measure method：

Grade 0: Skin is flat with visible skin markings (texture), soft/pliable consistency, and no color mismatch (pigmentation). Grade +: Slight surface irregularity or pigmentation changes, poor skin markings, and slightly firm consistency. Grade ++: Obvious surface irregularity, loss of skin markings, and hard/indurated consistency. Grade +++: Formation of hypertrophic scarring.

指标中文名：

满意度评分

指标类型：

次要指标

Outcome：

Satisfaction score

Type：

Secondary indicator

测量时间点：

末次治疗后第24周

测量方法：

李克特量表

Measure time point of outcome：

24 weeks after the final treatment

Measure method：

Likert scale

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 0.3 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）：

由独立统计师使用计算机生成混合区组长度的分配序列，即随机穿插长度为4和6的区组，每个区组内A组（瘤体基底部注射组）/B组（瘤体部注射组）比例严格为1:1，且分配顺序是随机的。

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

The allocation sequence was generated by an independent statistician using computer software, employing mixed block lengths. Blocks of sizes 4 and 6 were randomly permuted, ensuring a strict 1:1 allocation ratio between Group A (Compound Basal Injection Group) and Group B (Intratumoral Injection Group) within each block.

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：

本研究采用单盲法： 1.疗效评估者设盲：负责进行疗效评价和瘢痕分级的研究者（评估者）不参与患者的招募与治疗，且在评估时对患者的分组信息保持未知。所有用于评估的临床照片仅保留瘤体本身的影像，确保评估者无法根据针眼推断分组，并隐去患者身份和分组信息。 2.治疗实施者和患者不设盲：由于进针部位的本质差异，无法对操作医师及患儿监护人实施设盲。向所有监护人明确强调，两种注射方法都是临床常规使用的方法，其优劣正是本研究旨在回答的科学问题，从观念上避免其产生“某组更优”的预设立场。

Blinding：

This study employed a single-blind design: Blinding of Outcome Assessors: The researchers responsible for efficacy evaluation and scar grading (outcome assessors) were not involved in patient recruitment or treatment and remained blinded to group allocation during the assessment. All clinical photographs used for evaluation were cropped to display only the tumor itself, ensuring that assessors could not deduce the group assignment based on the location of needle puncture sites. Patient identity and group information were strictly de-identified. Non-blinding of Practitioners and Patients: Due to the inherent differences in the needle entry points between the two techniques, it was not possible to blind the operating physicians or the patients' guardians. To minimize expectation bias, it was clearly emphasized to all guardians that both injection methods are standard clinical procedures. They were informed that the specific scientific objective of this study was to determine the comparative superiority of these methods, thereby preventing any preconceived notion that one group was superior to the other.

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）：

无

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

None

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：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-12-23 09:01:31