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Robot-assisted vs VATS for Thymoma

Recruiting
18 - 75 years of age
Both
Phase N/A

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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.

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.

Eligibility

Inclusion Criteria:

  1. ) The age of the subjects on the day of signing the informed consent was ≥ 18 years old and < 75 years old, regardless of gender ;
  2. ) 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.
  3. ) need to accept thymectomy surgery ;
  4. ) Clinical stage I to IIIA ( AJCC-UICC TNM staging system ) ;
  5. ) The maximum diameter of the lesion < 5cm ;
  6. ) physical condition score 0 or 1 ( Eastern Cooperative Oncology Group ECOG scoring system ) ;
  7. ) Have not received any anti-thymoma therapy before, including but not limited to systemic chemotherapy, radiotherapy, etc. ;
  8. ) 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 ) ;
  9. ) voluntarily participated in and were able to undergo robot-assisted or thoracoscopic thymectomy, and complied with the study follow-up plan.

Exclusion Criteria:

  1. ) Patients with myasthenia gravis crisis ;
  2. ) had undergone mediastinal surgery or cardiac surgery ;
  3. ) body mass index ( BMI ) ≥ 30 ;
  4. ) 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 ) ;
  5. ) combined with severe chronic lung diseases such as COPD, asthma, or interstitial lung disease ;
  6. ) suffering from uncontrolled heart, kidney, gastrointestinal, and infectious diseases and other complications ;
  7. ) patients with other malignant tumors or hematological diseases ;
  8. ) combined with chronic pain or preoperative use of opioid analgesics ;
  9. ) patients with thoracic deformity or combined with pectus carinatum and pectus excavatum ;
  10. ) have mental disorders, such as anxiety disorders ;
  11. ) pregnant and/or lactating women ;
  12. ) is currently participating in other interventional clinical studies.

Study details

Thymoma

NCT06029621

Shanghai Pulmonary Hospital, Shanghai, China

8 March 2024

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