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
1 other identifier
interventional
304
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2023
CompletedFirst Posted
Study publicly available on registry
September 8, 2023
CompletedStudy Start
First participant enrolled
November 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 19, 2030
February 29, 2024
February 1, 2024
6.8 years
August 28, 2023
February 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
5-year overall survival (OS)
OS at 5 year after surgery
5 year after surgery
Secondary Outcomes (15)
Pain score
at 1 year after surgery
quality of life (QOL) at 1 year by EORTC QLQ-C30
at 1 year after surgery
quality of life (QOL) at 1 year by EQ-5D
at 1 year after surgery
R0 rate
postoperative in-hospital stay up to 30 days
operative time
Intraoperative
- +10 more secondary outcomes
Study Arms (2)
RATS for Thymectomy
EXPERIMENTALThe operator of the surgical incision and the route of entry were determined, and the endoscope and surgical instruments were inserted through the operating hole. The phrenic nerve and diaphragm began to gradually separate upward while avoiding nerve damage. Subsequently, the innominate vein was dissected to observe the branches of the thymus vessels and clamped with a 5 mm Hem-o-Lok clamp. Continue to dissect the left side of the thymus until near the phrenic nerve. After the thymus was removed entirely, it was placed in a bag and removed through an incision. After the operation, a 28 Fr chest tube was placed through the incision to the chest top. An 18 G central venous catheter was placed at the level of the posterior axillary line to the posterior costophrenic angle, and about 10 cm was inserted.
VATS for Thymectomy
ACTIVE COMPARATORThe main operation principles and procedures of the operation are basically similar to those of the RATS and are completed under video-assisted thoracoscopic surgery.
Interventions
Eligibility Criteria
You may qualify if:
- ) 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.
You may not qualify if:
- ) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deping Zhao, MD,PhD
Shanghai Pulmonary Hospital, School of Medicine, Tongji University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- no masking
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Administrative Director of Thoracic Surgery Department
Study Record Dates
First Submitted
August 28, 2023
First Posted
September 8, 2023
Study Start
November 20, 2023
Primary Completion (Estimated)
September 19, 2030
Study Completion (Estimated)
September 19, 2030
Last Updated
February 29, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share