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

Primary Purpose

Esophagus Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Single-hole inflatable mediastinal mirror
Sponsored by
Qingdong Cao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagus Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Chao-yang Hospital
  • Affiliated Daping Hospital
  • The First Affiliated Hospital of Xiamen University
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Shantou Central Hospital
  • Affiliated Hospital of Zunyi Medical CollegeRecruiting
  • The Second Affiliated Hospital of Hainan Medical University
  • Harbin Medical University Cancer Hospital
  • Anyang Cancer HospitalRecruiting
  • Xiangyang No.1 People's HospitalRecruiting
  • The First People's Hospital of Changzhou
  • Jiansu Cancer HospitalRecruiting
  • Jining No.1 People's HospitalRecruiting
  • Shanghai Changzheng Hospital
  • Shanghai Chest HospitalRecruiting
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
  • General Hospital of Ningxia Medical UniversityRecruiting
  • Affiliated Tumor Hospital of Xinjiang Medical University
  • The First People's Hospital of Yunnan Province
  • Zhejiang Cancer Hospital
  • Ningbo No.2 Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inflatable mediastinal mirror

Arm Description

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.

Outcomes

Primary Outcome Measures

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
Number of lymph nodes dissected
number of lymph nodes dissected during operation

Secondary Outcome Measures

Intraoperative bleeding volume
Calculation of intraoperative bleeding with ml/kg
Operative time
Calculate the operating time in minutes
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
Intraoperative mortality
The ratio of the number of patients who died during the operation to the number of patients who underwent the operation
Postoperative hospital stay
The days of postoperative hospitalization
Postoperative pain score
Daily pain scores were recorded by VAS (Visual Analogue Scale/Score) 1-3 days after operation
Postoperative icu monitoring time
If the patient needs to be transferred to ICU after operation, stay in icu monitoring time should be observed
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)
Postoperative drainage
Total postoperative thoracic or mediastinal drainage (ml/kg)
Postoperative drainage tube indwelling time
The retention time of different types of drainage tube

Full Information

First Posted
August 6, 2018
Last Updated
September 3, 2018
Sponsor
Qingdong Cao
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1. Study Identification

Unique Protocol Identification Number
NCT03657914
Brief Title
Radical Resection of Single-hole Inflatable Mediastinal Mirror Synchronization With Laparoscopic Esophageal Carcinoma
Official Title
A Multi-center Clinical Study on the Feasibility and Safety of Radical Resection of Single-hole Inflatable Mediastinal Mirror Synchronization With Laparoscopic Esophageal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 12, 2017 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Qingdong Cao

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
155 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inflatable mediastinal mirror
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Single-hole inflatable mediastinal mirror
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perioperative complication rate
Description
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
Time Frame
Through operation completion, an average of 12 days
Title
Number of lymph nodes dissected
Description
number of lymph nodes dissected during operation
Time Frame
During the operation
Secondary Outcome Measure Information:
Title
Intraoperative bleeding volume
Description
Calculation of intraoperative bleeding with ml/kg
Time Frame
During the operation
Title
Operative time
Description
Calculate the operating time in minutes
Time Frame
During the operation
Title
Proportion of patients undergoing thoracotomy or laparotomy
Description
The ratio of the number of patients converted to thoracotomy or laparotomy to the total number of patients undergoing surgery
Time Frame
During the operation
Title
Intraoperative mortality
Description
The ratio of the number of patients who died during the operation to the number of patients who underwent the operation
Time Frame
During the operation
Title
Postoperative hospital stay
Description
The days of postoperative hospitalization
Time Frame
Up to 2 weeks after the operation
Title
Postoperative pain score
Description
Daily pain scores were recorded by VAS (Visual Analogue Scale/Score) 1-3 days after operation
Time Frame
1-3 days after the operation
Title
Postoperative icu monitoring time
Description
If the patient needs to be transferred to ICU after operation, stay in icu monitoring time should be observed
Time Frame
0-12 days after the operation
Title
Incidence of adverse events during and after operation
Description
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)
Time Frame
3 years
Title
Postoperative drainage
Description
Total postoperative thoracic or mediastinal drainage (ml/kg)
Time Frame
0-12 days after the operation
Title
Postoperative drainage tube indwelling time
Description
The retention time of different types of drainage tube
Time Frame
0-12 days after the operation
Other Pre-specified Outcome Measures:
Title
Local recurrence rate of tumor within 3 years
Description
The rate of tumor recurrence or metastasis
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cao Qingdong, bachelor
Phone
+86 13680356988
Email
13680356988@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Xiaojin, master
Phone
+86 13798967219
Email
wxjhny@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Shaoxuan, master
Organizational Affiliation
Office of clinical research center
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Chao-yang Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Hui, doctor
Facility Name
Affiliated Daping Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tan Qunyou, doctor
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Xiuyi, doctor
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Ju, doctor
Facility Name
Shantou Central Hospital
City
Shantou
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fu Junhui, doctor
Facility Name
Affiliated Hospital of Zunyi Medical College
City
Zunyi
State/Province
Guizhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cai Qingyong, master
Facility Name
The Second Affiliated Hospital of Hainan Medical University
City
Haikou
State/Province
Hainan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wu Huangfu
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ma Jianqun, doctor
Facility Name
Anyang Cancer Hospital
City
Anyang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hou Jianbin, doctor
Facility Name
Xiangyang No.1 People's Hospital
City
Xiangyang
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei Yunqing, doctor
Facility Name
The First People's Hospital of Changzhou
City
Changzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Zhonglin
Facility Name
Jiansu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hu Zhendong, doctor
Facility Name
Jining No.1 People's Hospital
City
Jining
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Kang
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
XU Zhifei, doctor
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Yifeng, doctor
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fu Junke, doctor
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
The Ningxia Hui Autonomous Region
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
He Wei, master
Facility Name
Affiliated Tumor Hospital of Xinjiang Medical University
City
Ürümqi
State/Province
Xinjiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Wei, doctor
Facility Name
The First People's Hospital of Yunnan Province
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pu Liang, doctor
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Jinshi
Facility Name
Ningbo No.2 Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhao Guofang

12. IPD Sharing Statement

Learn more about this trial

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

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