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NCT05105945Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2021 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
1164 (estimated)
First submitted
16 Sept 2021
Start date
11 Nov 2021
Primary completion date
28 Dec 2027
Lead sponsor
Fifth Affiliated Hospital, Sun Yat-Sen University
NCT number
NCT05105945

What you commit to

  • Study type: Interventional
  • Planned participants: 1164
  • From 11 Nov 2021 to the primary completion date, 28 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with cachexia and severe malnutrition who cannot tolerate surgery;
  • 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.

Other illness

  • 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;
  • People suffering from mental, mental or neurological diseases;
  • Recent recurrence of gastric ulcer, history of gastric bleeding and other serious underlying diseases;
  • Patients with surgical contraindications such as blood coagulation dysfunction, HIV antibody positive, and poorly controlled clinically severe infections;

Other

  • Patients who have participated in other clinical studies;
  • Others judged by the investigator to be unsuitable to participate in this clinical trial.

Who the study is looking for

  • 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;
  • The tumor has not invaded the surrounding vital organs and has metastasized far away;
  • The function of major organs is basically normal: general anesthesia is acceptable for lung function; NYHA grade of heart function is 0\~1;
  • 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;

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
The Fifth Affiliated Hospital of Sun Yat-sen University
Coordinator of this site? Confirm its status
ZhuhaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.