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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Esophagus Cancer

Intervention / Treatment
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* Procedure: Single-hole inflatable mediastinal mirror


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inflatable mediastinal mirror<br>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<br>* 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.<br>|

What is the study measuring?
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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 |