Tubeless VATS for Mediastinal Neoplasm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShuben Li
About this trial
In recent year, non-intubated anesthesia had emerged as an available and promising alternative for thoracic procedure. However, its safety and feasibility in video-assisted thoracoscopic surgery (VATS) for mediastinal neoplasm remain controversial. This randomized controlled trial is designed to evaluate the impact of the non-intubated approach on surgical and perioperative outcomes in patients undergoing mediastinal neoplasm resection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Mediastinal neoplasm was diagnosed by chest enhanced CT
The patients with age ≥ 18 and ≤ 80 years old
The patients whose tumor diameter was <6 cm
ASA grade: I-III
Disqualifiers
Imaging examinations revealed that the tumor had invaded adjacent organs, with evidence of pleural or pericardial dissemination, as well as lymphatic and/or hematogenous metastases
Patients with a confirmed history of congestive heart failure, poorly controlled angina despite medical therapy, electrocardiogram-confirmed myocardial infarction with transmural involvement, uncontrolled hypertension, clinically significant valvular heart disease, or high-risk arrhythmias not adequately managed
Patients with concurrent active malignancies
Trial design
Design model
Parallel
Treatments tested in this trial
Non-intubated VATS for mediastinal neoplasm
Procedure/SurgeryNon-intubated VATS for mediastinal neoplasm
Intubated VATS for mediastinal neoplasm
Procedure/SurgeryIntubated VATS for mediastinal neoplasm
Treatment groups
132 Participants
are divided into 2 treatment groupsGroup A: Non-intubated groupExperimental treatment 1 intervention
Group B: Intubated groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Conversion rate to open surgery
Proportion of patients requiring conversion from VATS to open surgery.
Time frame
postoperative in-hospital stay up to 30 days2
Conversion rate to intubated anesthesia
Proportion of patients requiring conversion from non-intubated approach to intubated anesthesia
Time frame
postoperative in-hospital stay up to 30 days3
Postoperative complication rate
Incidence and severity of treatment-related adverse events, classified by Clavien-Dindo for surgical complications and CTCAE v5.0 for systemic adverse events.
Time frame
postoperative in-hospital stay up to 30 daysSecondary outcomes
1
R0 rate
R0 resection rate
Time frame
postoperative in-hospital stay up to 30 days2
Operation time
Operative time was defined as the time between the start of the surgery (incision) and the finish of surgery (closure of the skin).
Time frame
postoperative in-hospital stay up to 30 days3
Intraoperative bleeding loss
The volume of bleeding during the surgery.
Time frame
postoperative in-hospital stay up to 30 days4
ICU stay
ICU stay (in days), defined as the duration from ICU admission post-surgery to ICU discharge.
Time frame
postoperative in-hospital stay up to 30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shuben Li
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Sponsor institution
The First Affiliated Hospital of Guangzhou Medical University
Collaborator
Source ClinicalTrials.gov