ChiCTR2600119809 版本V1.0 版本创建时间2026/03/04 08:34:06 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：

ChiCTR2600119809 

最近更新日期：

Date of Last Refreshed on：

2026-03-04 08:33:40 

注册时间：

Date of Registration：

2026-03-04 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

“桥式”自牵引技术治疗胃贲门半环周肿瘤的疗效与安全性研究：一项随机对照试验

Public title：

Superior Efficacy and Safety of the "Bridge Technique" Self-Traction in Endoscopic Submucosal Dissection for Semi-Circumferential Gastric Cardia Neoplasms: A Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

超1/2周贲门肿瘤内镜下黏膜剥离术中“桥式自牵引术”的疗效评估

Scientific title：

Therapeutic efficacy of the "Bridge Technique" self-traction method for Endoscopic Submucosal Dissection (ESD) of cardiac neoplasm involving more than half the circumference

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：

薛林云 

研究负责人：

薛林云 

Applicant：

Linyun Xue  

Study leader：

Linyun Xue  

申请注册联系人电话：

Applicant telephone：

+86 188 5090 9922

研究负责人电话：

Study leader's telephone：

+86 188 5090 9922

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：

linyunxue83@163.com

研究负责人电子邮件：

Study leader's E-mail：

linyunxue83@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：

福建省莆田市城厢区南门西路449号莆田市第一医院 消化内科

研究负责人通讯地址：

福建省莆田市城厢区南门西路449号莆田市第一医院 消化内科

Applicant address：

Department of Gastroenterology, The First Hospital of Putian City, 449 South Menxi Road, Chengxiang District, Putian City, Fujian Province 351100, P.R. China

Study leader's address：

Department of Gastroenterology, The First Hospital of Putian City, 449 South Menxi Road, Chengxiang District, Putian City, Fujian Province 351100, P.R. 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：

申请人所在单位：

莆田市第一医院

Applicant's institution：

The First Hospital of Putian City

研究负责人所在单位：

莆田市第一医院

Affiliation of the Leader：

The First Hospital of Putian City

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2020-007

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：

莆田市第一医院伦理委员会

Name of the ethic committee：

Ethics Committee of The First Hospital of Putian City

伦理委员会批准日期：

Date of approved by ethic committee：

2020-06-02 00:00:00

伦理委员会联系人：

马建栋

Contact Name of the ethic committee：

Jiandong Ma

伦理委员会联系地址：

福建省莆田市城厢区南门西路449号莆田市第一医院 消化内科

Contact Address of the ethic committee：

Department of Gastroenterology, The First Hospital of Putian City, 449 South Menxi Road, Chengxiang District, Putian City, Fujian Province 351100, P.R. China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 139 5076 7599

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：

莆田市第一医院

Primary sponsor：

The First Hospital of Putian City

研究实施负责（组长）单位地址：

福建省莆田市城厢区南门西路449号莆田市第一医院

Primary sponsor's address：

Department of Gastroenterology, The First Hospital of Putian City, 449 South Menxi Road, Chengxiang District, Putian City, Fujian Province 351100, P.R. China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

福建省

市(区县)：

莆田市

Country：

China

Province：

Fujian Province

City：

Putian City

单位(医院)：

莆田市第一医院

具体地址：

福建省莆田市城厢区南门西路449号莆田市第一医院

Institution
hospital：

The First Hospital of Putian City

Address：

Department of Gastroenterology, The First Hospital of Putian City, 449 South Menxi Road, Chengxiang District, Putian City, Fujian Province 351100, P.R. China

经费或物资来源：

本院基金

Source(s) of funding：

Hospital’s Internal Funds

Target disease：

Gastric Cardia Neoplasms

Target disease code：

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：

主要目的：比较“桥式”自牵引ESD技术与传统ESD技术治疗胃贲门半环周或更大范围肿瘤的整块切除率。 次要目的：比较两种技术在手术时间、切除速度、术中出血量、黏膜下注射量、并发症（如穿孔、迟发出血、狭窄、感染）发生率以及住院时间等方面的差异。  

Objectives of Study：

Primary Objective: To compare the en bloc resection rates between the "Bridge Technique" self-traction Endoscopic Submucosal Dissection (ESD) and conventional ESD for the treatment of semi-circumferential or larger neoplasms in the gastric cardia. Secondary Objectives: To compare the differences between the two techniques in terms of procedure time, resection speed, volume of intraoperative bleeding, volume of submucosal injection, incidence of complications (e.g., perforation, delayed bleeding, stricture, infection), and length of hospital stay.

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18-80岁。 2.经胃镜活检病理证实为胃贲门部位（定义为胃食管连接处远端2cm范围内）的腺瘤或早期腺癌（包括高级别上皮内瘤变）。 3.病灶符合日本《胃癌治疗指南》ESD绝对或扩大适应证：（1）无溃疡的黏膜内（cT1a）肠型腺癌（不限大小）；（2）直径<=3cm的溃疡性黏膜内肠型腺癌；（3）直径<=2cm的无溃疡黏膜内弥漫型腺癌。 4.病灶范围符合以下任一条件：（1）累及贲门环周>=50%（半环周）；（2）最大直径>=3cm。 5.术前经超声内镜（EUS）及放大内镜（ME）评估，浸润深度符合ESD治疗指征。 6.术前胸腹部增强CT检查排除淋巴结及远处转移。 7.签署书面知情同意书。

Inclusion criteria

1. Age 18–80 years. 2. Pathologically confirmed via endoscopic biopsy as adenoma or early adenocarcinoma (including high-grade intraepithelial neoplasia) of the gastric cardia (defined as within 2 cm distal to the gastroesophageal junction). 3. Lesions meeting absolute or extended ESD indications per the Japanese Gastric Cancer Treatment Guidelines: (1) Non-ulcerative mucosal-layer intestinal-type adenocarcinoma (cT1a stage, any size); (2) Ulcerative mucosal-layer intestinal-type adenocarcinoma <=3cm in diameter; (3) Non-ulcerative mucosal-layer diffuse-type adenocarcinoma <=2cm in diameter. 4. Lesion extent meeting any of the following criteria: (1) Circumferential infiltration >=50% (semi-circumferential infiltration); (2) Maximum diameter >=3cm. 5. Preoperative endoscopic ultrasound (EUS) and magnifying endoscopy (ME) confirm infiltration depth meets ESD treatment criteria. 6. Preoperative contrast-enhanced chest and abdominal CT excludes lymph node metastasis and distant metastasis. 7. Written informed consent has been obtained.

排除标准：

1.影像学检查提示存在淋巴结或远处转移。 2.存在严重全身性疾病，无法耐受麻醉或内镜操作（如美国纽约心脏病学会心功能分级III/IV级、严重呼吸功能不全）。 3.未纠正的凝血功能障碍。 4.既往有涉及贲门部位的手术史。 5.妊娠或哺乳期妇女。

Exclusion criteria：

1.Evidence of lymph node or distant metastasis on imaging studies. 2.Severe systemic diseases precluding safe anesthesia or endoscopic procedures (e.g., New York Heart Association Class III/IV heart failure, severe respiratory insufficiency). 3.Uncorrected coagulopathy. 4.History of prior gastric surgery involving the cardia region. 5)Pregnancy or lactation.

研究实施时间：

Study execute time：

从 From 2020-07-01 00:00:00至 To 2023-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2020-07-01 00:00:00 至 To 2023-12-31 00:00:00  

干预措施：

Interventions：

组别：

对照组（传统ESD组，CESD）

样本量：

40

Group：

Conventional ESD(CESD)

Sample size：

干预措施：

使用单通道治疗内镜（GIF-Q260J；Olympus）及透明帽。常规步骤包括：病灶边缘外缘标记、黏膜下注射（含亚甲蓝和肾上腺素）、环周黏膜切开、黏膜下剥离。使用高频电刀（MFK；安瑞医疗）进行切开与剥离。术中必要时使用电刀头或止血钳进行内镜下止血。

干预措施代码：

Intervention：

The procedure was regularly performed with a single-channel endoscope (GIF-Q260J; Olympus Optical, Tokyo, Japan) with a transparent cap attached. The conventional ESD techniques were previously detailed. Briefly, following the placement of circumferential marking dots outside the lesion margins, a submucosal injection containing Methylene Blue and Epinephrine was administered. Subsequently, a circumferential mucosal incision was performed, followed by submucosal dissection. Both steps utilized a high-frequency electrosurgical knife (MFK; Anrei Medical Co., Ltd., China). Hemostasis during the procedure was achieved endoscopically using either the knife tip itself or hemostatic forceps.

Intervention code：

组别：

试验组（“桥式”自牵引ESD组，BT-ESD）

样本量：

40

Group：

The "Bridge Technique" self-traction ESD (BT-ESD)

Sample size：

干预措施：

使用设备同对照组。黏膜切开步骤与传统ESD相同。关键改良在于黏膜下剥离阶段：在正镜视野下进行剥离时，于贲门小弯侧有意保留一条宽约3-5mm、具有一定厚度的黏膜下组织条带,该条带在张力下形成天然的“桥式”牵引，将已剥离的黏膜瓣向上抬起，有效防止其塌陷至剥离平面，维持了清晰稳定的手术视野。随后，向病灶中央及大弯侧方向进行剥离，直至与肛侧缘贯通，形成“两侧牵引、中央贯通”的桥形结构。在直视下确认病灶主体已切除后，最后安全离断小弯侧预留的牵引组织带。

干预措施代码：

Intervention：

The procedure was regularly performed with a single-channel endoscope (GIF-Q260J; Olympus Optical, Tokyo, Japan) with a transparent cap attached.The mucosal incision around the lesion is performed in the same manner as in conventional ESD. During submucosal dissection in the forward view, a bridge of submucosal tissue at the lesser curvature side of the cardia (approximately 3-5 mm in width and maintaining adequate thickness for mechanical support) is deliberately preserved. This creates a pivotal self-traction effect. The preserved tissue band, under inherent tension, lifts the dissected mucosal flap away from the dissection plane, effectively preventing its sagging or collapse into the operative field. The central and greater curvature aspects of the lesion are then progressively dissected until the anal margin is reached and connected. This results in a ‘bridge-like’ structure providing bilateral traction with a fully dissected central corridor. The efficacy of the traction was directly assessed visually during the procedure: effective traction was confirmed by the sustained elevation of the mucosal flap and the maintenance of a clear, unobstructed submucosal dissection plane. Only after the major part of the lesion was removed under this stable view were the remaining traction tissue bands at the lesser curvature side finally and safely transected? (Figure1 and Figure 2). Both steps utilized a high-frequency electrosurgical knife (MFK; Anrei Medical Co., Ltd., China). Hemostasis during the procedure was achieved endoscopically using either the knife tip itself or hemostatic forceps.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 福建省 

市(区县)：

 莆田市 

Country：

China 

Province：

Fujian Province 

City：

Putian City 

单位(医院)：

莆田市第一医院 

单位级别：

三甲 

Institution
hospital：

The First Hospital of Putian City

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

整块切除率

指标类型：

主要指标

Outcome：

Complete resection rate

Type：

Primary indicator

测量时间点：

手术完成时

测量方法：

Measure time point of outcome：

Upon completion of the ESD procedure

Measure method：

指标中文名：

手术时间

指标类型：

次要指标

Outcome：

procedure duration

Type：

Secondary indicator

测量时间点：

手术完成时

测量方法：

计算从黏膜切开至标本完全切除的时间

Measure time point of outcome：

Upon completion of the ESD procedure

Measure method：

Operative time was defined as the interval from the initial mucosal incision to the complete resection of the specimen

指标中文名：

切除速度

指标类型：

次要指标

Outcome：

resection speed

Type：

Secondary indicator

测量时间点：

手术完成时

测量方法：

标本面积（mm）/手术时间（min）

Measure time point of outcome：

Upon completion of the ESD procedure

Measure method：

The speed of ESD was calculated as the resected specimen area (in mm2) divided by the total procedure time (in minutes)

指标中文名：

术中出血次数

指标类型：

次要指标

Outcome：

Intraprocedural bleeding frequency

Type：

Secondary indicator

测量时间点：

手术完成时

测量方法：

术中需要止血钳止血的次数

Measure time point of outcome：

Upon completion of the ESD procedure

Measure method：

Instances of hemostasis were tallied specifically when targeted coagulation with hemostatic forceps was required to secure hemostasis in the setting of active bleeding

指标中文名：

术中黏膜下注射液体总量

指标类型：

次要指标

Outcome：

Intraoperative injection volume(ml)

Type：

Secondary indicator

测量时间点：

手术完成时

测量方法：

术中因剥离需要进行粘膜下注射的液体总量

Measure time point of outcome：

Upon completion of the ESD procedure

Measure method：

The intraoperative injection volume was defined as the total submucosally injected fluid volume during ESD procedure

指标中文名：

穿孔

指标类型：

次要指标

Outcome：

Perforation

Type：

Secondary indicator

测量时间点：

手术完成时

测量方法：

Measure time point of outcome：

upon completion of the ESD procedure

Measure method：

指标中文名：

术后迟发性出血

指标类型：

主要指标

Outcome：

Delayed bleeding

Type：

Primary indicator

测量时间点：

术后1周

测量方法：

观察是否呕血、黑便

Measure time point of outcome：

one week after completion of the ESD procedure

Measure method：

Delayed bleeding was defined as clinical evidence of gastrointestinal hemorrhage following ESD that necessitated a blood transfusion or an endoscopic/surgical hemostatic intervention.

指标中文名：

感染

指标类型：

次要指标

Outcome：

infection

Type：

Secondary indicator

测量时间点：

术后1周

测量方法：

Measure time point of outcome：

one week after completion of the ESD procedure

Measure method：

指标中文名：

狭窄

指标类型：

次要指标

Outcome：

Postprocedural stricture

Type：

Secondary indicator

测量时间点：

术后3个月内

测量方法：

Measure time point of outcome：

three months after completion of the ESD procedure

Measure method：

指标中文名：

病灶大小

指标类型：

附加指标

Outcome：

lesion dimensions

Type：

Additional indicator

测量时间点：

手术完成时

测量方法：

Measure time point of outcome：

Upon completion of the ESD procedure

Measure method：

指标中文名：

病灶部位

指标类型：

附加指标

Outcome：

lesion location

Type：

Additional indicator

测量时间点：

术中

测量方法：

Measure time point of outcome：

during the ESD procedure

Measure method：

指标中文名：

组织病理学

指标类型：

附加指标

Outcome：

Histological assessment of the endoscopically resected specimen

Type：

Additional indicator

测量时间点：

术后1周内

测量方法：

Measure time point of outcome：

one week after completion of the ESD procedure

Measure method：

指标中文名：

住院天数

指标类型：

附加指标

Outcome：

Hospital days

Type：

Additional indicator

测量时间点：

出院时

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：

贲门组织

组织：

Sample Name：

Cardiac tissue

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 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）：

采用计算机生成的随机数字序列，将符合纳入标准的患者按1:1比例随机分配至传统ESD组或“桥式”自牵引ESD组。

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

Eligible patients were randomly assigned in a 1:1 ratio to either the conventional ESD (CESD) group or the "Bridge Technique" self-traction ESD (BTESD) group using a computer-generated random number sequence.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

由于干预措施的技术特性，本研究对操作内镜医师和患者无法设盲。但对病理学评估医师（负责评估切缘状态等）设盲，其不知晓患者的分组情况。

Blinding：

Due to the inherent technical nature of the interventions, blinding of the performing endoscopist and the patients was not feasible in this study. However, the pathologist assessing the specimens (e.g., for margin status evaluation) was blinded to the group allocation of the patients.

是否共享原始数据：

IPD sharing

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）：

本研究支持科学数据的开放共享，相关去标识化数据可在论文发表后，经合理请求并获通讯作者批准后提供，以用于学术研究。

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

his study supports the open sharing of scientific data, and relevant de identified data can be provided for academic research after publication, upon reasonable request and approval from the corresponding author.

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：

经过统一培训的课题组成员，对病例进行原始纸质版采集监测指标及分组情况，再双录入校验（两名录入员分别录入同一份数据，系统自动比对差异），分类归档至电子表格

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

The project team members, who have undergone unified training, collect and monitor the original paper-based case data and grouping information, then perform double data entry verification (two data entry personnel separately enter the same data, and the system automatically compares the differences), and categorize and archive them into spreadsheets.

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：

  2026-03-04 08:33:40