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

Qingdong Cao

Status: Unknown

Conditions: Esophagus Cancer

Treatments: Procedure: Single-hole inflatable mediastinal mirror

Study type: Interventional

Funder types: Other

Identifiers

NCT03657914

ZDWY.XXW.001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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155 participants in 1 patient group

Inflatable mediastinal mirror

Experimental group

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.

Treatment:

Procedure: Single-hole inflatable mediastinal mirror