A Randomized Controlled Trial of Non-intubated Versus Intubated VATS for Mediastinal Neoplasm
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Conversion rate to open surgery
Study Overview
Brief Summary
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.
Detailed Description
Non-intubated anesthesia has gained widespread adoption in recent years, representing a significant advancement in both thoracic surgery and anesthetic practice. The surgical safety and feasibility of tubeless VATS for mediastinal neoplasm has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial. Accordingly, this randomized controlled trial aims to evaluate whether the non-intubated approach provides comparable short-term and long-term outcomes to the conventional intubated technique in VATS for mediastinal neoplasm resection.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •The patients should understand the research and sign the informed consent
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Conversion rate to open surgery
Time Frame: postoperative in-hospital stay up to 30 days
Proportion of patients requiring conversion from VATS to open surgery.
Postoperative complication rate
Time Frame: postoperative in-hospital stay up to 30 days
Incidence and severity of treatment-related adverse events, classified by Clavien-Dindo for surgical complications and CTCAE v5.0 for systemic adverse events.
Conversion rate to intubated anesthesia
Time Frame: postoperative in-hospital stay up to 30 days
Proportion of patients requiring conversion from non-intubated approach to intubated anesthesia
Secondary Outcomes
- R0 rate(postoperative in-hospital stay up to 30 days)
- 1-year disease-free survival (DFS)(1 year after surgery)
- Operation time(postoperative in-hospital stay up to 30 days)
- Hospital stay(postoperative in-hospital stay up to 30 days)
- Intraoperative bleeding loss(postoperative in-hospital stay up to 30 days)
- ICU stay(postoperative in-hospital stay up to 30 days)
- Volume of postoperative drainage(postoperative in-hospital stay up to 30 days)
- 1-year overall survival(OS)(1 year after surgery)
- Quality of life (QOL) at 3 month(Quality of life (QOL) at 3 months post-discharge, as measured by [specify QOL scale], reflecting patient-reported physical, emotional, and social well-being.)
Investigators
Shuben Li
Deputy Director
The First Affiliated Hospital of Guangzhou Medical University