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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

ConditionEsophageal Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFifth Affiliated Hospital, Sun Yat-Sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years old ≤ age ≤ 75 years old, no gender limit;

Patients who are diagnosed as esophageal malignant tumor by cytology or histology, and agree to undergo surgical treatment;

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;

The tumor is located in the thoracic esophagus;

Disqualifiers

People who suffer from other malignant tumors at the same time;

Patients with a history of esophagus or gastrectomy;

Patients with a history of mediastinal surgery or extensive abdominal cavity adhesion;

Patients with basic diseases such as cardiovascular and cerebrovascular diseases;

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/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.

  • Thoracoscopy Combined With Laparoscopic Surgery

    Procedure/Surgery

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

Treatment groups

1,164 Participants
are divided into 2 treatment groups
Group A: Single port inflatable mediastinoscope and synchronized laparoscopic radical resectionExperimental treatment 1 intervention
Group B: Thoracoscopy combined with laparoscopic radical resectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Perioperative incidence of cardiopulmonary complications

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

Time frame
Through operation completion, an average of 12 days
2

disease-free survival（DFS）

The period after Operation treatment \[tumor eliminated\] when no disease can be detected

Time frame
After surgery-related treatment until the tumor recurrence，assessed up to 5 years
3

overall survival（OS）

When the precise cause of Esophageal cancer death is not specified, this is called the overall survival rate or observed survival rate. Doctors use mean overall survival rates to estimate the patient's prognosis. This is often expressed over standard time periods, like one, five, and ten years.

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

Secondary outcomes

1

intraoperative blood loss

Calculation of intraoperative bleeding with ml/kg

Time frame
During the operation, an average of 2 hours
2

Operation time

Calculate the operating time in minutes

Time frame
During the operation, an average of 2 hours
3

Proportion of patients who converted to thoracotomy and laparotomy

The ratio of the number of patients converted to thoracotomy or laparotomy to the total number of patients undergoing surgery

Time frame
During the operation, an average of 2 hours
4

Intraoperative mortality rate

The ratio of the number of patients who died during the operation to the number of patients who underwent the operation

Time frame
During the operation, an average of 2 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fifth Affiliated Hospital, Sun Yat-Sen University

Lead sponsor

General Hospital of Ningxia Medical University

Collaborator

Beijing Chao Yang Hospital

Collaborator

West China Hospital

Collaborator

Shanghai Chest Hospital

Collaborator

Peking University Cancer Hospital & Institute

Collaborator

The First Affiliated Hospital of Nanchang University

Collaborator

Changzhi Medical College

Collaborator

Zhangzhou Affiliated Hospital of Fujian Medical University

Collaborator

Harbin Medical University

Collaborator

Hubei Cancer Hospital

Collaborator

Jining First People's Hospital

Collaborator

Jiangsu Cancer Institute & Hospital

Collaborator

Nanfang Hospital, Southern Medical University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: