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

Fifth Affiliated Hospital, Sun Yat-Sen University

Status: Not yet enrolling

Conditions: Esophageal Cancer

Treatments: Procedure: Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery; Procedure: Thoracoscopy Combined With Laparoscopic Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05105945

ZDWY.XXW.005

Details and patient eligibility

About

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.

Full description

To reduce postoperative pulmonary complications, considerable efforts have been made to develop the nontransthoracic esophagectomy for esophageal cancer. For instance, esophageal stripping and transhiatal esophagectomy are the nontransthoracic operations developed for treatment for esophageal cancer. These methods possess several advantages, including non-thoracotomy, less postoperative pain, less postoperative cardiac and pulmonary complications, and safer for elderly patients. However, these two methods are limited with the poor surgical view, poor mediastinal lymph node dissection (especially upper mediastinal lymph nodes), and high risk of bleeding.

In 2015 and 2016, Prof. Fujiwara has developed novel surgical methods on the dissection of upper mediastinal lymph nodes using single-port mediastinoscopy through the cervical incision and the lower mediastinal lymph nodes (including the subcarinal lymph nodes) by laparoscopy, respectively.For the first time, non-transthoracic radical resection of esophageal cancer could be achieved along with the dissection of all the mediastinal lymph nodes. Based on the Fujiwara's method, we further improved this surgical method to the"single-port inflatable mediastinoscopy combined with laparoscopy for the radical treatment of esophageal cancer"and has successfully performed this novel surgical method for the first case in March 2016. We have completed over 200 cases of radical resection of esophageal carcinoma using this novel surgical technique from May 2016 to August 2021.

This is a prospective, multicenter, open clinical study in which 1164 patients (including 10% drop-off 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 5 years postoperatively. Primary study outcome are the prioperative complication rate and the number of intraoperative lymph node dissection.

Enrollment: 1,164 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,164 participants in 2 patient groups

Single port inflatable mediastinoscope and synchronized laparoscopic radical resection

Experimental group

Description:

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.

Treatment:

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

Thoracoscopy combined with laparoscopic radical resection

Active Comparator group

Description:

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

Treatment:

Procedure: Thoracoscopy Combined With Laparoscopic Surgery