Radical Resection of Single-hole Inflatable Mediastinal Mirror Synchronization With Laparoscopic Esophageal Carcinoma

A Multi-center Clinical Study on the Feasibility and Safety of Radical Resection of Single-hole Inflatable Mediastinal Mirror Synchronization With Laparoscopic Esophageal Carcinoma

This study is evaluating the feasibility and safety of radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma, as well as the clinical value of the radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma as a new minimally invasive operation for esophageal carcinoma.

Study Overview

• Status: Unknown
• Conditions: Esophagus Cancer
• Intervention / Treatment: Procedure: Single-hole inflatable mediastinal mirror

Detailed Description

This is a prospective, multicenter, open clinical study in which 155 patients (including 5% shedding rate) who require surgical treatment are scheduled to be included in the study. Prior to any screening process, each subject / legal guardian should sign the informed consent form. Screening tests are used to determine whether each subject is eligible for the study. Eligible subjects who meet the standard will be treated with radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma and followed up until 3 years postoperatively. Primary study outcome are the prioperative complication rate and the number of intraoperative lymph node dissection.

• Study Type: Interventional
• Enrollment (Anticipated): 155
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cao Qingdong, bachelor; Phone Number: +86 13680356988; Email: 13680356988@163.com
• Study Contact Backup: Name: Wang Xiaojin, master; Phone Number: +86 13798967219; Email: wxjhny@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Not yet recruiting
      • Beijing Chao-Yang Hospital
      • Contact: Li Hui, doctor
  • Chongqing
    • Chongqing, Chongqing, China
      • Not yet recruiting
      • Affiliated Daping Hospital
      • Contact: Tan Qunyou, doctor
  • Fujian
    • Xiamen, Fujian, China
      • Not yet recruiting
      • The First Affiliated Hospital of Xiamen University
      • Contact: Yu Xiuyi, doctor
  • Guangdong
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Contact: Chen Ju, doctor
    • Shantou, Guangdong, China
      • Not yet recruiting
      • Shantou Central Hospital
      • Contact: Fu Junhui, doctor
  • Guizhou
    • Zunyi, Guizhou, China
      • Recruiting
      • Affiliated Hospital of Zunyi Medical College
      • Contact: Cai Qingyong, master
  • Hainan
    • Haikou, Hainan, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Hainan Medical University
      • Contact: Wu Huangfu
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Not yet recruiting
      • Harbin Medical University Cancer Hospital
      • Contact: Ma Jianqun, doctor
  • Henan
    • Anyang, Henan, China
      • Recruiting
      • Anyang Cancer Hospital
      • Contact: Hou Jianbin, doctor
  • Hubei
    • Xiangyang, Hubei, China
      • Recruiting
      • Xiangyang No.1 People's Hospital
      • Contact: Mei Yunqing, doctor
  • Jiangsu
    • Changzhou, Jiangsu, China
      • Not yet recruiting
      • The First People's Hospital of Changzhou
      • Contact: Wang Zhonglin
    • Nanjing, Jiangsu, China
      • Recruiting
      • Jiansu Cancer Hospital
      • Contact: Hu Zhendong, doctor
  • Shandong
    • Jining, Shandong, China
      • Recruiting
      • Jining No.1 People's Hospital
      • Contact: Zhang Kang
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Sun Yifeng, doctor
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • Shanghai Changzheng Hospital
      • Contact: XU Zhifei, doctor
  • Shanxi
    • Xi'an, Shanxi, China
      • Recruiting
      • The First Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Fu Junke, doctor
  • The Ningxia Hui Autonomous Region
    • Yinchuan, The Ningxia Hui Autonomous Region, China
      • Recruiting
      • General Hospital of Ningxia Medical University
      • Contact: He Wei, master
  • Xinjiang
    • Ürümqi, Xinjiang, China
      • Not yet recruiting
      • Affiliated Tumor Hospital of Xinjiang Medical University
      • Contact: Sun Wei, doctor
  • Yunnan
    • Kunming, Yunnan, China
      • Not yet recruiting
      • The First People's Hospital of Yunnan Province
      • Contact: Pu Liang, doctor
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • Zhejiang Cancer Hospital
      • Contact: Liu Jinshi
    • Ningbo, Zhejiang, China
      • Not yet recruiting
      • Ningbo No.2 Hospital
      • Contact: Zhao Guofang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 18-85 years male and female
• Patients with esophageal squamous cell carcinoma diagnosed by cytological or histological examination, requires surgical treatment
• Patients in tumor stage of T1-2N0-1M0 confirmed by ultrasonic gastroscopy preoperatively;Or patients in T3N1M0 (IIIa) reached PR after neoadjuvant radio(chemo-) therapy, suitable for surgical resection
• The tumor located in the chest or abdomen segment of esophagus
• No surrounding vital organs were invaded and no distant metastasis
• No obvious enlargement was shown in supraclavicular and retroperitoneal lymph nodes, no evidence of distant metastasis (M0)
• Vital organs function normally: lung functions normally and could stand general anesthesia; NYHA heart function grade 0 ~ 1
• Informed consent was signed as voluntarily before study, and patients and/or the legal representatives have the ability to fully understand test content/result, process and possible adverse reactions, and patients could comply with the requirements of the follow-up scheme
• Reproductive women must show a negative pregnancy test, and it should be confirmed that both the women patient and her spouse are taking contraceptives recognized by researchers, and should keep taking this contraceptive by signing the informed consent until 3 months after the study was finished.

Exclusion Criteria:

• Patients with other malignant tumors at the same time
• Patients having surgery history of esophageal or gastric resection
• Patients having a history of mediastinal surgery or vast peritoneal adhesion
• Patients with heart thromboembolism at the same time
• People with psychological, mental or nervous system diseases
• Cachexia, severe malnutrition patients
• Patients with history of recent recurrence of gastric ulcer, stomach bleeding and other severe basic diseases
• Patients with blood coagulation dysfunction, HIV antibody positive, or surgical contraindications such as clinically poorly controlled serious infection
• The subjects with other associated disease (such as liver and renal dysplasia, etc.) or drug combination, which could influence the study results recognized by the researchers
• Patients participating in another clinical study
• Patients with surgical instruments material allergy, or allergic constitution
• The subjects are not judged by investigator to participate in this Clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inflatable mediastinal mirror; Patients with especially esophageal squamous cell carcinoma ( ESCC ) who meet the inclusion criteria and do not meet the exclusion criteria will undergo radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma, and will be followed up until 3 years after discharging from the hospital.	Procedure: Single-hole inflatable mediastinal mirror; The radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma is new minimally invasive operation for esophageal carcinoma. All enrolled subjects will receive this operation for their ESCC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative complication rate	Perioperative complications include: pulmonary infection, respiratory failure, managed pleural effusion, heart failure, myocardial infarction, managed arrhythmia, anastomotic fistula or gastric fistula, recurrent laryngeal nerve injury, chylothorax, unscheduled reoperation	Through operation completion, an average of 12 days
Number of lymph nodes dissected	number of lymph nodes dissected during operation	During the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative bleeding volume	Calculation of intraoperative bleeding with ml/kg	During the operation
Operative time	Calculate the operating time in minutes	During the operation
Proportion of patients undergoing thoracotomy or laparotomy	The ratio of the number of patients converted to thoracotomy or laparotomy to the total number of patients undergoing surgery	During the operation
Intraoperative mortality	The ratio of the number of patients who died during the operation to the number of patients who underwent the operation	During the operation
Postoperative hospital stay	The days of postoperative hospitalization	Up to 2 weeks after the operation
Postoperative pain score	Daily pain scores were recorded by VAS (Visual Analogue Scale/Score) 1-3 days after operation	1-3 days after the operation
Postoperative icu monitoring time	If the patient needs to be transferred to ICU after operation, stay in icu monitoring time should be observed	0-12 days after the operation
Incidence of adverse events during and after operation	Special attention is paid to observing whether arrhythmias need to be dealt with during the operation (record the types of arrhythmias, treatment methods, medication, time of occurrence, possible causes)	3 years
Postoperative drainage	Total postoperative thoracic or mediastinal drainage (ml/kg)	0-12 days after the operation
Postoperative drainage tube indwelling time	The retention time of different types of drainage tube	0-12 days after the operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local recurrence rate of tumor within 3 years	The rate of tumor recurrence or metastasis	3 years

Collaborators and Investigators

• Sponsor: Qingdong Cao
• Investigators: Study Chair: Liu Shaoxuan, master, Office of clinical research center

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2017
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: September 3, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 3, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: ZDWY.XXW.001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No