An interventional study of Non-intubated VATS for mediastinal neoplasm and Intubated VATS for mediastinal neoplasm in Mediastinal Neoplasm, VATS and Tubeless, sponsored by Shuben Li. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-15.
Sponsored by Shuben Li · Not applicable, Interventional, and Treatment
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.
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.
21 studies on the registry are indexed under Mediastinal Neoplasms; 7 are open to participants now.
This study's planned enrollment of 132 is above the median of 100 across 19 interventional studies indexed under Mediastinal Neoplasms.
Browse Mediastinal Neoplasms studies →Shuben Li is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients received tubeless VATS for mediastinal neoplasm
Procedure: Non-intubated VATS for mediastinal neoplasm
Patients received VATS mediastinal neoplasm resection under intubated general anesthesia.
Procedure: Intubated VATS for mediastinal neoplasm
Non-intubated VATS for mediastinal neoplasm
Intubated VATS for mediastinal neoplasm
Conversion rate to open surgery
Proportion of patients requiring conversion from VATS to open surgery.
Time frame: postoperative in-hospital stay up to 30 days
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 days
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 days
R0 rate
R0 resection rate
Time frame: postoperative in-hospital stay up to 30 days
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 days
Intraoperative bleeding loss
The volume of bleeding during the surgery.
Time frame: postoperative in-hospital stay up to 30 days
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 days
Hospital stay
Hospital stay, defined as the duration from the day of surgery to the day of discharge.
Time frame: postoperative in-hospital stay up to 30 days
Volume of postoperative drainage
Volume of postoperative drainage, measured from the end of surgery until drain removal.
Time frame: postoperative in-hospital stay up to 30 days
1-year disease-free survival (DFS)
1-year disease-free survival (DFS), defined as the percentage of patients alive without evidence of tumor recurrence or progression at 12 months.
Time frame: 1 year after surgery
1-year overall survival(OS)
1-year overall survival(OS), defined as the percentage of patients alive at 12 months from the date of surgery or treatment initiation, irrespective of disease recurrence or progression.
Time frame: 1 year after surgery
Quality of life (QOL) at 3 month
3 months after discharge
Time frame: Quality of life (QOL) at 3 months post-discharge, as measured by [specify QOL scale], reflecting patient-reported physical, emotional, and social well-being.
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for May 2028, 37 months after the start.
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