Clinical trial NCT06029621: Robot-assisted vs VATS for Thymoma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thymoma
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RATS versus VATS
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: 5-year overall survival (OS)
timeFrame: 5 year after surgery
Secondary outcomes:
measure: Pain score
timeFrame: at 1 year after surgery
measure: quality of life (QOL) at 1 year by EORTC QLQ-C30
timeFrame: at 1 year after surgery
measure: quality of life (QOL) at 1 year by EQ-5D
timeFrame: at 1 year after surgery
measure: R0 rate
timeFrame: postoperative in-hospital stay up to 30 days
measure: operative time
timeFrame: Intraoperative
measure: blood loss
timeFrame: Intraoperative
measure: conversion rate
timeFrame: Intraoperative
measure: length of hospital stay (LOS)
timeFrame: postoperative in-hospital stay up to 30 days
measure: Catheterization days
timeFrame: postoperative in-hospital stay up to 30 days
measure: Volume of drainage
timeFrame: postoperative in-hospital stay up to 30 days
measure: postoperative complications
timeFrame: postoperative in-hospital stay up to 30 days
measure: 30-day mortality
timeFrame: postoperative in-hospital stay up to 30 days
measure: 30-day readmission rate after surgery
timeFrame: postoperative in-hospital stay up to 30 days
measure: 5-year disease-free survival (DFS)
timeFrame: 5 year after surgery
measure: Tumor recurrence rate
timeFrame: 5 year after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Zhejiang
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
Study officials:
affiliation: Shanghai Pulmonary Hospital, School of Medicine, Tongji University
name: Deping Zhao, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: