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Robot-assisted vs VATS for Thymoma | Clinical Trials | Clareo Health

RECRUITINGNA

Robot-assisted vs VATS for Thymoma

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

NCT06029621•Shanghai Pulmonary Hospital, Shanghai, China

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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 ;
+2 more criteria

Locations (2)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Zhejiang, China

Key Dates

Start Date

November 20, 2023

Primary Completion Date

September 19, 2030

Completion Date

September 19, 2030

Last Updated

February 29, 2024

Enrollment

304

ESTIMATED participants

Conditions

Thymoma

Interventions

RATS for Thymectomy

PROCEDURE

VATS for Thymectomy

PROCEDURE

Contacts

Juemin Yu

CONTACT

+8615927548511 yujm96@163.com

Deping Zhao, MD,PhD

CONTACT

+8613701816883 zdp1992@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 29, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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