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NCT Number: NCT06029621

Robot-assisted vs VATS for Thymoma

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Pulmonary Hospital, Shanghai, Shanghai Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RATS for Thymectomy

Procedure

a minimally invasive surgical type for Thymoma: RATS

VATS for Thymectomy

Procedure

a minimally invasive surgical type for Thymoma: VATS

Primary outcomes

  1. 5-year overall survival (OS)

    Time frame: 5 year after surgery

    OS at 5 year after surgery

Secondary outcomes

  1. Pain score

    Time frame: at 1 year after surgery

    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

  2. quality of life (QOL) at 1 year by EORTC QLQ-C30

    Time frame: at 1 year after surgery

    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

  3. quality of life (QOL) at 1 year by EQ-5D

    Time frame: at 1 year after surgery

    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).

  4. R0 rate

    Time frame: postoperative in-hospital stay up to 30 days

    R0 radical rate

  5. operative time

    Time frame: Intraoperative

    the time of operation

  6. blood loss

    Time frame: Intraoperative

    blood loss in the operation

  7. conversion rate

    Time frame: Intraoperative

    the rate of conversion to open surgery in the operation

  8. length of hospital stay (LOS)

    Time frame: postoperative in-hospital stay up to 30 days

    length of stay in hospitalization

  9. Catheterization days

    Time frame: postoperative in-hospital stay up to 30 days

    The interval days from the completion of catheter insertion to the removal of the thoracic tube

  10. Volume of drainage

    Time frame: postoperative in-hospital stay up to 30 days

    Volume of drainage from the completion of catheter insertion to the removal of the thoracic tube

  11. postoperative complications

    Time frame: postoperative in-hospital stay up to 30 days

    mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula

  12. 30-day mortality

    Time frame: postoperative in-hospital stay up to 30 days

    30-day mortality after surgery

  13. 30-day readmission rate after surgery

    Time frame: postoperative in-hospital stay up to 30 days

    Rate of readmission due to postoperative complications

  14. 5-year disease-free survival (DFS)

    Time frame: 5 year after surgery

    DFS at 5 year after surgery

  15. Tumor recurrence rate

    Time frame: 5 year after surgery

    The rate of recurrence of thymoma in patients after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Deping Zhao, MD,PhD

CONTACT

[email protected]

+8613701816883

Juemin Yu

CONTACT

[email protected]

+8615927548511

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Sep 8, 2023
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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