NCT07065604

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
28mo left

Started Mar 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Mar 2025Aug 2028

Study Start

First participant enrolled

March 26, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

3.1 years

First QC Date

July 4, 2025

Last Update Submit

July 4, 2025

Conditions

Mediastinal NeoplasmVATSTubelessNon-intubated Anesthesia

Keywords

Non-intubated AnesthesiaTubelessMediastinal NeoplasmVATS

Outcome Measures

Primary Outcomes (3)

  • Conversion rate to open surgery

    Proportion of patients requiring conversion from VATS to open surgery.

    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

    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.

    postoperative in-hospital stay up to 30 days

Secondary Outcomes (9)

  • R0 rate

    postoperative in-hospital stay up to 30 days

  • Operation time

    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

  • Hospital stay

    postoperative in-hospital stay up to 30 days

  • +4 more secondary outcomes

Study Arms (2)

Non-intubated group

EXPERIMENTAL

Patients received tubeless VATS for mediastinal neoplasm

Procedure: Non-intubated VATS for mediastinal neoplasm

Intubated group

ACTIVE COMPARATOR

Patients received VATS mediastinal neoplasm resection under intubated general anesthesia.

Procedure: Intubated VATS for mediastinal neoplasm

Interventions

Non-intubated VATS for mediastinal neoplasmPROCEDURE

Non-intubated VATS for mediastinal neoplasm

Non-intubated group
Intubated VATS for mediastinal neoplasmPROCEDURE

Intubated VATS for mediastinal neoplasm

Intubated group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Mediastinal Neoplasms

Condition Hierarchy (Ancestors)

Thoracic NeoplasmsNeoplasms by SiteNeoplasmsMediastinal DiseasesThoracic DiseasesRespiratory Tract Diseases

Central Study Contacts

Shuben Li, Deputy Director

CONTACT

86(020) 8306 211413500030280@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy Director

Study Record Dates

First Submitted

July 4, 2025

First Posted

July 15, 2025

Study Start

March 26, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

July 15, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)