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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03657914
Other study ID # ZDWY.XXW.001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 12, 2017
Est. completion date March 2019

Study information

Verified date September 2018
Source Fifth Affiliated Hospital, Sun Yat-Sen University
Contact Cao Qingdong, bachelor
Phone +86 13680356988
Email 13680356988@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 155
Est. completion date March 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Anyang Cancer Hospital Anyang Henan
China Beijing Chao-yang Hospital Beijing Beijing
China The First People's Hospital of Changzhou Changzhou Jiangsu
China Affiliated Daping Hospital Chongqing Chongqing
China Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong
China The Second Affiliated Hospital of Hainan Medical University Haikou Hainan
China Zhejiang Cancer Hospital Hangzhou Zhejiang
China Harbin Medical University Cancer Hospital Harbin Heilongjiang
China Jining No.1 People's Hospital Jining Shandong
China The First People's Hospital of Yunnan Province Kunming Yunnan
China Jiansu Cancer Hospital Nanjing Jiangsu
China Ningbo No.2 Hospital Ningbo Zhejiang
China Shanghai Changzheng Hospital Shanghai Shanghai
China Shanghai Chest Hospital Shanghai Shanghai
China Shantou Central Hospital Shantou Guangdong
China Affiliated Tumor Hospital of Xinjiang Medical University Ürümqi Xinjiang
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi
China The First Affiliated Hospital of Xiamen University Xiamen Fujian
China Xiangyang No.1 People's Hospital Xiangyang Hubei
China General Hospital of Ningxia Medical University Yinchuan The Ningxia Hui Autonomous Region
China Affiliated Hospital of Zunyi Medical College Zunyi Guizhou

Sponsors (1)

Lead Sponsor Collaborator
Qingdong Cao

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Local recurrence rate of tumor within 3 years The rate of tumor recurrence or metastasis 3 years
Primary 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
Primary Number of lymph nodes dissected number of lymph nodes dissected during operation During the operation
Secondary Intraoperative bleeding volume Calculation of intraoperative bleeding with ml/kg During the operation
Secondary Operative time Calculate the operating time in minutes During the operation
Secondary 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
Secondary 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
Secondary Postoperative hospital stay The days of postoperative hospitalization Up to 2 weeks after the operation
Secondary 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
Secondary 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
Secondary 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
Secondary Postoperative drainage Total postoperative thoracic or mediastinal drainage (ml/kg) 0-12 days after the operation
Secondary Postoperative drainage tube indwelling time The retention time of different types of drainage tube 0-12 days after the operation
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