Robot-assisted vs VATS for Thymoma
ConditionThymoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Pulmonary Hospital, Shanghai, China
About this trial
The aim of this study is to explore the advantages of robot-assisted thymectomy in long-term survival benefits and short-term clinical efficacy compared with video-assisted thoracoscopic thymectomy based on a multi-center, prospective, randomized controlled clinical trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
) The age of the subjects on the day of signing the informed consent was ≥ 18 years old and < 75 years old, regardless of gender ;
) Chest thin-layer CT and MR showed anterior mediastinal space-occupying lesions, combined with relevant hematological indicators, the patient was clinically diagnosed as a thymic epithelial tumor with or without myasthenia gravis ( MG ) symptoms.
) need to accept thymectomy surgery ;
) Clinical stage I to IIIA ( AJCC-UICC TNM staging system ) ;
Disqualifiers
) Patients with myasthenia gravis crisis ;
) had undergone mediastinal surgery or cardiac surgery ;
) body mass index ( BMI ) ≥ 30 ;
) Patients with severe liver and kidney dysfunction ( ALT and/or AST more than three times the upper limit of normal, Cr more than the upper limit of normal ) ;
Trial design
Design model
Parallel
Treatments tested in this trial
RATS for Thymectomy
Procedure/Surgerya minimally invasive surgical type for Thymoma: RATS
VATS for Thymectomy
Procedure/Surgerya minimally invasive surgical type for Thymoma: VATS
Treatment groups
304 Participants
are divided into 2 treatment groupsGroup A: RATS for ThymectomyExperimental treatment 1 intervention
Group B: VATS for ThymectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
5-year overall survival (OS)
OS at 5 year after surgery
Time frame
5 year after surgerySecondary outcomes
1
Pain score
Pain was assessed using a pain scale on the first day, 1 month, 6 months and 1 year after surgery. Pain was evaluated using the visual analogue scale (VAS) and the numerical rating scale (NRS), with higher scores indicating greater pain
Time frame
at 1 year after surgery2
quality of life (QOL) at 1 year by EORTC QLQ-C30
Quality of life was assessed at 1 month, 6 months and 1 year after surgery. QQL was evaluated using the European Organization for the Treatment and Research of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0
Time frame
at 1 year after surgery3
quality of life (QOL) at 1 year by EQ-5D
Quality of life was assessed at 1 month, 6 months and 1 year after surgery. QQL was evaluated using the European Five Dimensional Health Scale (EQ-5D).
Time frame
at 1 year after surgery4
R0 rate
R0 radical rate
Time frame
postoperative in-hospital stay up to 30 daysSponsors and contacts
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Source ClinicalTrials.gov