Esophagus Cancer
Conditions
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.
Interventions
PROCEDURESingle-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.
Sponsors
Qingdong Cao
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of lymph nodes dissected | During the operation | number of lymph nodes dissected during operation |
| Perioperative complication rate | Through operation completion, an average of 12 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | During the operation | Calculate the operating time in minutes |
| Proportion of patients undergoing thoracotomy or laparotomy | During the operation | The ratio of the number of patients converted to thoracotomy or laparotomy to the total number of patients undergoing surgery |
| Intraoperative mortality | During the operation | The ratio of the number of patients who died during the operation to the number of patients who underwent the operation |
| Postoperative hospital stay | Up to 2 weeks after the operation | The days of postoperative hospitalization |
| Postoperative icu monitoring time | 0-12 days after the operation | 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 | 3 years | 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 | 0-12 days after the operation | Total postoperative thoracic or mediastinal drainage (ml/kg) |
| Postoperative drainage tube indwelling time | 0-12 days after the operation | The retention time of different types of drainage tube |
| Postoperative pain score | 1-3 days after the operation | Daily pain scores were recorded by VAS (Visual Analogue Scale/Score) 1-3 days after operation |
| Intraoperative bleeding volume | During the operation | Calculation of intraoperative bleeding with ml/kg |
Other
| Measure | Time frame | Description |
|---|---|---|
| Local recurrence rate of tumor within 3 years | 3 years | The rate of tumor recurrence or metastasis |
Countries
China
Contacts
Primary ContactCao Qingdong, bachelor
Backup ContactWang Xiaojin, master
Outcome results
None listed