ChiCTR2300071691 版本V1.0 版本创建时间2023/05/22 17:05:53 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：

 ChiCTR2300071691 

最近更新日期：

Date of Last Refreshed on：

 2023-05-22 17:05:32 

注册时间：

Date of Registration：

 2023-05-22 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

双层扇贝状吻合法在下段食管癌和食管胃结合部癌Ivor-Lewis 术中的应用与评价

Public title：

The evaluation of the Double-layered scallop-shaped anastomosis in Ivor-Lewis surgery for lower esophageal cancer and esophagogastric junction cancer.

注册题目简写：

PPIO-3 (患者问题导向系列研究-3)

English Acronym：

PPIO-3 (Patient perspective issue-oriented-3)

研究课题的正式科学名称：

双层扇贝状吻合法在下段食管癌和食管胃结合部癌Ivor-Lewis 术中的应用与评价

Scientific title：

The evaluation of the Double-layered scallop-shaped anastomosis in Ivor-Lewis surgery for lower esophageal cancer and esophagogastric junction cancer.

研究课题代号(代码)：

Study subject ID：

 PPIO-3

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：

李昆昆 

研究负责人：

李昆昆 

Applicant：

Kunkun Li 

Study leader：

Kunkun Li 

申请注册联系人电话：

Applicant telephone：

 +86 136 3797 1863

研究负责人电话：

Study leader's
telephone：

+86 136 3797 1863

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：

 kunkun.li@hotmail.com

研究负责人电子邮件：

Study leader's E-mail：

 kunkun.li@hotmail.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：

重庆市渝中区长江支路10号第一住院部B区8楼胸外一科

研究负责人通讯地址：

重庆市渝中区长江支路10号第一住院部B区8楼胸外一科

Applicant address：

8th Floor, Block B, the First Inpatient Department, 10 Changjiang Road, Yuzhong District, Chongqing

Study leader's address：

8th Floor, Block B, the First Inpatient Department, 10 Changjiang Road, Yuzhong District, Chongqing

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：

陆军军医大学大坪医院

Applicant's institution：

Daping Hospital, Army Medical University

研究负责人所在单位：

陆军军医大学大坪医院

Affiliation of the Leader：

Daping Hospital, Army Medical University

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：

 医研伦审(2023)第41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：

中国人民解放军陆军特色医学中心伦理委员会

Name of the ethic committee：

Ethics Committee of Army Medical Center of PLA

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-03-30 00:00:00

伦理委员会联系人：

王晶晶

Contact Name of the ethic committee：

Jingjing Wang

伦理委员会联系地址：

重庆市渝中区长江支路10号E区5楼

Contact Address of the ethic committee：

Fifth Floor, Block E, 10 Changjiang Branch Road, Yuzhong District, Chongqing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 23 6875 7140

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：

陆军军医大学大坪医院

Primary sponsor：

Daping Hospital, Army Medical University

研究实施负责（组长）单位地址：

重庆市渝中区长江支路10号

Primary sponsor's address：

10 Changjiang Branch Road, Yuzhong District, Chongqing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

重庆

市(区县)：

Country：

China

Province：

Chongqing

City：

单位(医院)：

陆军军医大学大坪医院

具体地址：

重庆市渝中区长江支路10号

Institution
hospital：

Daping Hospital, Army Medical University

Address：

10 Changjiang Road, Yuzhong District, Chongqing

经费或物资来源：

重庆市医学科研项目（卫生健康委员会和科技局联合项目）

Source(s) of funding：

Chongqing medical scientific research project (Joint project of Chongqing Health Commission and Science and Technology Bureau)

研究疾病：

下段食管癌及食管胃结合部癌  

Target disease：

lower esophageal cancer and esophagogastric junction cancer.

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：

 I期+II期 

Study phase：

1-2

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究拟通过前瞻性随机对照研究和传统的微创圆形吻合器吻合方法比较，进一步评估双层扇贝状吻合方法的近期疗效，以期降低下段食管癌及食管胃结合部癌患者的术后并发症，减少患者医疗负担和痛苦，提高生活质量。同时也为微创Ivor-Lewis手术的应用和推广提供重要支持，让更多患者受益。  

Objectives of Study：

The current study aims to conduct a prospective randomized controlled trial to compare the traditional minimally invasive circular stapler anastomosis method with the double-layered scallop-shaped anastomosis method. The objective is to further evaluate the short-term efficacy of the latter in reducing postoperative complications in patients with lower esophageal cancer and esophagogastric junction cancer, thereby reducing the medical burden and pain of the patients and improving their quality of life. Additionally, the study will provide important support for the application and promotion of minimally invasive Ivor-Lewis surgery, ultimately benefiting a larger patient population.

药物成份或治疗方案详述：

胸腹腔镜Ivor-Lewis手术步骤： ① 腹腔镜下游离胃：维持气腹压力12 mmHg左右，选脐孔切口置入30°腹腔镜，探查腹腔无明显粘连，腹腔脏器无异常后，选左、右肋弓下及脐上5mm为操作孔。于大网膜无血管区用5mm超声刀切开大网膜囊，沿胃网膜血管弓外侧分离胃大弯侧网膜组织，右至十二指肠球部，保留胃网膜右动脉及其血管弓；向左游离并切断胃网膜左动脉、胃短动脉；切开小网膜囊，游离胃左动、静脉，清扫肝总、胃左、脾动脉、腹腔干动脉旁淋巴结。延长剑突下切口至3cm，将食管及胃拖出后制作管胃，丝线牵引，放回腹腔备用，关闭腹部切口，结束腹部操作。 ② 胸腔镜下游离胸段食管：全麻、单腔气管插管，建立人工气胸，维持气胸压力8 mmHg左右，右侧腋中线第六肋间戳孔，入镜，右侧腋前线第四肋间、腋后线第六肋间、肩胛下角线第八肋间戳孔，置入腔镜器械；镜下钝性＋锐性解剖分离食管周围疏松组织，双重结扎并切断奇静脉弓，分离胸段食管及肿瘤，清扫纵隔淋巴结，注意保护双侧喉返神经、胸导管、气管膜部。将管胃从食管裂孔牵至胸腔。 ③ 管胃及食管吻合： i）双层扇贝状吻合： a. 在管胃的管腔和食管近端之间插入线性直线切割缝合器； b. 粘膜层用3-0抗菌薇乔线连续缝合； c. 肌层用3-0抗菌薇乔线连续缝合； d. 吻合后三维形状类似于扇贝，故命名为双层扇贝状吻合。 

Description for medicine or protocol of treatment in detail：

Surgical steps of thoracoabdominal Ivor-Lewis operation: Laparoscopic mobilization of the stomach: With a pneumoperitoneum pressure of approximately 12 mmHg, a 30° laparoscope is inserted through an umbilical incision. After examining the abdominal cavity for adhesions or abnormalities, 5-mm trocars are placed in the left and right subcostal areas and the umbilicus. The great omentum is incised using a 5-mm ultrasonic scalpel, and the gastric greater curvature is dissected along the outer side of the gastrosplenic ligament, extending to the duodenal bulb. The right gastric artery and its arcade are preserved, while the left gastric artery and the short gastric arteries are divided. The lesser omentum is then opened, and the left gastric vessels, hepatic artery, splenic artery, and celiac trunk lymph nodes are dissected. The incision is extended to a 3 cm length below the xiphoid, and the esophagus and stomach are exteriorized to create a gastric conduit, which is then placed back into the abdominal cavity and secured with sutures. The abdominal incision is closed, completing the abdominal part of the operation. Thoracoscopic dissection of the thoracic esophagus: Under general anesthesia and single-lumen endotracheal intubation, an artificial pneumothorax is established at a pressure of approximately 8 mmHg. A 12-mm trocar is placed in the right sixth intercostal space along the mid-axillary line, and other trocars are inserted at the fourth intercostal space along the anterior axillary line, the sixth intercostal space along the posterior axillary line, and the eighth intercostal space along the scapular line. Using a combination of blunt and sharp dissection, the surrounding loose tissue of the esophagus is dissected, and the arch of the azygos vein is ligated and divided. The thoracic esophagus and tumor are dissected, and the mediastinal lymph nodes are cleared while protecting the bilateral recurrent laryngeal nerves, thoracic duct, and tracheal membrane. The gastric conduit is then pulled up into the chest through the esophageal hiatus. Anastomosis of the gastric conduit and esophagus: i) Double-layered scallop-shaped anastomosis: a. A linear cutting stapler is inserted between the lumen of the gastric conduit and the proximal esophagus; b. The mucosal layer is continuously sutured using 3-0 Vicryl antibacterial suture; c. The muscular layer is continuously sutured using 3-0 Vicryl antibacterial suture; d. The anastomosis has a three-dimensional shape similar to a scallop, hence the name double-layered scallop-shaped anastomosis. 

纳入标准：

①经内镜及病理活检诊断为下段食管癌或食管胃结合部癌； ②术前cTNM分期或术前新辅助治疗后分期 ypTNM分期≤IIIa期； ③肿瘤和淋巴结被判定为R0切除；④食管胃结合部癌仅限Siewert I和II型；⑤充分了解手术风险后同意接受手术者。

Inclusion criteria

①The diagnosis based on endoscopy and pathological biopsy is lower esophageal cancer or gastroesophageal junction cancer. ②Preoperative cTNM staging or post-neoadjuvant therapy ypTNM staging is ≤ IIIa stage. ③The tumor and lymph nodes were determined to have been R0 resected. ④The cancer of the gastroesophageal junction is limited to Siewert types I and II. ⑤Surgery is agreed upon by individuals who have been fully informed about the surgical risks.

排除标准：

①年龄<18岁或>80岁；②因心、肺、肝、肾等功能异常或全身一般情况难以耐受手术者；③拒绝接受手术者。

Exclusion criteria：

①Age <18 years old or >80 years old; ②Patients with cardiac, pulmonary, hepatic, renal dysfunction or poor general condition who are unable to tolerate surgery; ③Patients who refuse to undergo surgery.

研究实施时间：

Study execute time：

从 From 2023-05-15 00:00:00至 To 2024-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-05-15 00:00:00 至 To 2024-12-31 00:00:00

干预措施：

Interventions：

组别：

双层扇贝状吻合组

样本量：

 54

Group：

Group DLSSA

Sample size：

干预措施：

双层扇贝状吻合

干预措施代码：

Intervention：

Double-layered scallop-shaped anastomosis

Intervention code：

组别：

圆形吻合器吻合组

样本量：

 54

Group：

Group circular- stapler anastomosis

Sample size：

干预措施：

圆形吻合器吻合

干预措施代码：

Intervention：

circular- stapler anastomosis

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 重庆 

市(区县)：

  

Country：

China

Province：

Chongqing

City：

单位(医院)：

 陆军军医大学大坪医院 

单位级别：

 三甲 

Institution
hospital：

Daping Hospital, Army Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

吻合口瘘发生率

指标类型：

主要指标

Outcome：

Incidence of anastomotic leakage

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

吻合口狭窄发生率

指标类型：

次要指标

Outcome：

Incidence of anastomotic stricture

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生活质量评价

指标类型：

主要指标

Outcome：

quality of life

Type：

Primary indicator

测量时间点：

测量方法：

EORTC OG-25

Measure time point of outcome：

Measure method：

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

 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 18 岁 years
最大 Max age 79 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PASS软件中的Randomization list，将符合纳入、排除标准的患者分别随机分为双层扇贝状吻合组和传统圆形吻合器吻合组；

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

The Randomization list in PASS software was used to randomly allocate eligible patients, who met the inclusion and exclusion criteria, into either the bilayer staple group or the traditional circular stapler group.

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：

无/None

Blinding：

None

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/None

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：

无/None

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

None

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：

  2023-05-22 17:05:32