Recruiting NCT06029621

Robot-assisted vs VATS for Thymoma

No phase Interventional Thymoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: RATS for Thymectomy, VATS for Thymectomy.
Who it may be relevant to: Registry conditions: Thymoma. Basic parameters: 18 years — 75 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison of Short-term and Longterm Outcomes Between Robot-assisted Thoracoscopy and Television-assisted Thoracoscopy Surgery Forthymoma : a Multicenter, Prospective, Randomized Controlled Study

Overview

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.

Detailed description

Video-assisted thoracoscopic surgery ( VATS ) is widely used in thoracic surgery and has gradually replaced traditional thoracotomy in thymoma. As a new type of VATS, the long-term oncological results of robot-assisted thoracoscopic surgery in thymoma have not been verified. Therefore, we designed a multicenter, prospective, randomized controlled clinical trial to determine whether RATS thymectomy is as effective as VATS thymectomy in terms of short-term and long-term outcomes.

Interventions

Procedure RATS for Thymectomy
a minimally invasive surgical type for Thymoma: RATS
Procedure VATS for Thymectomy
a minimally invasive surgical type for Thymoma: VATS

Primary outcome measures

5-year overall survival (OS) [Time frame: 5 year after surgery]

Secondary outcome measures (12)

Pain score [Time frame: at 1 year after surgery]
quality of life (QOL) at 1 year by EORTC QLQ-C30 [Time frame: at 1 year after surgery]
quality of life (QOL) at 1 year by EQ-5D [Time frame: at 1 year after surgery]
R0 rate [Time frame: postoperative in-hospital stay up to 30 days]
operative time [Time frame: Intraoperative]
blood loss [Time frame: Intraoperative]
conversion rate [Time frame: Intraoperative]
length of hospital stay (LOS) [Time frame: postoperative in-hospital stay up to 30 days]
Catheterization days [Time frame: postoperative in-hospital stay up to 30 days]
Volume of drainage [Time frame: postoperative in-hospital stay up to 30 days]
postoperative complications [Time frame: postoperative in-hospital stay up to 30 days]
30-day mortality [Time frame: postoperative in-hospital stay up to 30 days]

Eligibility criteria

Inclusion criteria

) 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 ) ;
) The maximum diameter of the lesion < 5cm ;
) physical condition score 0 or 1 ( Eastern Cooperative Oncology Group ECOG scoring system ) ;
) Have not received any anti-thymoma therapy before, including but not limited to systemic chemotherapy, radiotherapy, etc. ;
) Preoperative major organ function meets the following criteria : Bone marrow function: hemoglobin ≥ 10.0 g / dL ( no blood transfusion within 28 days before hemoglobin examination ), absolute neutrophil count ≥ 1.5 × 109 / L, platelet count ≥ 100 × 109 / L ( no transfusion of apheresis platelets or IL-11 treatment within 14 days before platelet count examination ) ; coagulation function : INR and PT < 1.5 × ULN, APTT ≤ 1.5 × ULN ; liver function: transaminase ( ALT and AST ) ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN ( Gilbert's syndrome or liver metastasis subjects total bilirubin ≤ 2.5 × ULN ) ; renal function: serum creatinine clearance rate ≥ 60 mL/min ( calculated according to the Cockcroft-Gault formula ) ;
) voluntarily participated in and were able to undergo robot-assisted or thoracoscopic thymectomy, and complied with the study follow-up plan.

Exclusion criteria

) 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 ) ;
) combined with severe chronic lung diseases such as COPD, asthma, or interstitial lung disease ;
) suffering from uncontrolled heart, kidney, gastrointestinal, and infectious diseases and other complications ;
) patients with other malignant tumors or hematological diseases ;
) combined with chronic pain or preoperative use of opioid analgesics ;
) patients with thoracic deformity or combined with pectus carinatum and pectus excavatum ;
) have mental disorders, such as anxiety disorders ;
) pregnant and/or lactating women ;
) is currently participating in other interventional clinical studies.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

China · 2 centers

Shanghai Pulmonary Hospital — Shanghai
The Second Affiliated Hospital Zhejiang University School of Medicine — Zhejiang

Identifiers

NCT: NCT06029621 · STAR006

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗