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NCT05105945

Clinical Study on the Efficacy of Single-port Inflatable Mediastinoscopy Combined With Laparoscopic-assisted Small Incision Surgery and Thoracoscopy Combined With Laparoscopic Surgery for Radical Esophagectomy

Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

We previously developed a novel non-trans thoracic esophagectomy, the single-port inflatable mediastinoscopy combined with laparoscopy for the radical esophagectomy of esophageal cancer.This study is evaluating the feasibility and safety of radical resection of single-port inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma, as well as the clinical value of the radical resection of single-port inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma as a new minimally invasive operation for esophageal carcinoma.

Official title: A Randomized, Controlled, Multi-center Clinical Study on the Efficacy of Single-port Inflatable Mediastinoscopy Combined With Laparoscopic-assisted Small Incision Surgery and Thoracoscopy Combined With Laparoscopic Surgery for Radical Esophagectomy

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1164

Start Date

2021-11-11

Completion Date

2028-12-28

Last Updated

2021-11-03

Healthy Volunteers

Conditions

Esophageal Cancer

Interventions

PROCEDURE

Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery

Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery dissects, dissociates and removes the esophagus in the mediastinum through an inflatable endoscopy. Detailed surgical procedures and related instructions have been published in "Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery for Radical Esophagectomy Is an Effective and Safe Treatment for Esophageal Cancer" J Gastrointest Surg. 2019 Aug;23(8):1533-1540. doi: 10.1007/s11605-018-04069-w. Epub 2019 Jan 11.

PROCEDURE

Thoracoscopy Combined With Laparoscopic Surgery

Patients will receive a standardized thoracoscopy and laparoscopy combined radical esophageal cancer surgery

Inclusion Criteria: 1. 18 years old ≤ age ≤ 75 years old, no gender limit; 2. Patients who are diagnosed as esophageal malignant tumor by cytology or histology, and agree to undergo surgical treatment; 3. The preoperative clinical tumor staging is T1-2N0-1M0 patients; or T3N1-2M0 patients undergo neoadjuvant treatment (neoadjuvant chemotherapy, neoadjuvant chemoradiation, neoadjuvant radiotherapy, neoadjuvant chemotherapy and immunotherapy, neoadjuvant radiotherapy and immunotherapy After treatment), assess the tumor to achieve partial response (PR) and surgical resection is feasible; 4. The tumor is located in the thoracic esophagus; 5. The tumor has not invaded the surrounding vital organs and has metastasized far away; 6. The function of major organs is basically normal: general anesthesia is acceptable for lung function; NYHA grade of heart function is 0\~1; 7. Voluntarily sign an informed consent form before the study. The patient and/or his legal representative have the ability to fully understand the content, process and possible adverse reactions of the experiment, and enable the patient to comply with the visits stipulated in the plan; Exclusion Criteria: 1. People who suffer from other malignant tumors at the same time; 2. Patients with a history of esophagus or gastrectomy; 3. Patients with a history of mediastinal surgery or extensive abdominal cavity adhesion; 4. Patients with basic diseases such as cardiovascular and cerebrovascular diseases; 5. People suffering from mental, mental or neurological diseases; 6. Patients with cachexia and severe malnutrition who cannot tolerate surgery; 7. Recent recurrence of gastric ulcer, history of gastric bleeding and other serious underlying diseases; 8. Patients with surgical contraindications such as blood coagulation dysfunction, HIV antibody positive, and poorly controlled clinically severe infections; 9. Patients with other comorbid diseases (such as liver and kidney function abnormalities, etc.) or concomitant medications, which may have an impact on the results of this study based on the judgment of the investigator. 10. Patients who have participated in other clinical studies; 11. Others judged by the investigator to be unsuitable to participate in this clinical trial.

Locations (1)

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China