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
1 other identifier
interventional
155
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2017
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 12, 2017
CompletedFirst Submitted
Initial submission to the registry
August 6, 2018
CompletedFirst Posted
Study publicly available on registry
September 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedSeptember 5, 2018
September 1, 2018
1.6 years
August 6, 2018
September 3, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (10)
Intraoperative bleeding volume
During the operation
Operative time
During the operation
Proportion of patients undergoing thoracotomy or laparotomy
During the operation
Intraoperative mortality
During the operation
Postoperative hospital stay
Up to 2 weeks after the operation
- +5 more secondary outcomes
Other Outcomes (1)
Local recurrence rate of tumor within 3 years
3 years
Study Arms (1)
Inflatable mediastinal mirror
EXPERIMENTALPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Qingdong Caolead
Study Sites (21)
Beijing Chao-yang Hospital
Beijing, Beijing Municipality, China
Affiliated Daping Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Shantou Central Hospital
Shantou, Guangdong, China
Affiliated Hospital of Zunyi Medical College
Zunyi, Guizhou, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Anyang Cancer Hospital
Anyang, Henan, China
Xiangyang No.1 People's Hospital
Xiangyang, Hubei, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Jiansu Cancer Hospital
Nanjing, Jiangsu, China
Jining No.1 People's Hospital
Jining, Shandong, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
General Hospital of Ningxia Medical University
Yinchuan, The Ningxia Hui Autonomous Region, China
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Ningbo No.2 Hospital
Ningbo, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Liu Shaoxuan, master
Office of clinical research center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Thoracic and Cardiovascular Surgery Department
Study Record Dates
First Submitted
August 6, 2018
First Posted
September 5, 2018
Study Start
July 12, 2017
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
September 5, 2018
Record last verified: 2018-09