Actively Recruiting
Comparison of Short-term and Longterm Outcomes Between Robot-assisted Thoracoscopy and Video-assisted Thoracoscopy Surgery for Thymoma: a Multicenter, Prospective, Randomized Controlled Study
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2024-02-29
304
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the potential benefits of robot-assisted thoracoscopic surgery (RATS) compared to video-assisted thoracoscopic surgery (VATS) for treating thymoma, a tumor in the thymus gland. This multicenter, prospective, randomized controlled clinical trial aims to assess both short-term clinical outcomes and long-term survival benefits of these two minimally invasive surgical methods. The study focuses on whether RATS can achieve outcomes as effective as those from VATS in patients with thymic epithelial tumors. The trial compares two surgical approaches: RATS and VATS thymectomy. Both procedures involve minimally invasive surgery to remove the thymus and surrounding tissue. The surgeries follow similar principles, including careful dissection to avoid nerve damage, removal of the thymus tumor, and postoperative care involving chest tubes and catheters. The study includes a randomized assignment to either RATS or VATS groups to evaluate differences in operating time, blood loss, complications, and recovery. Participants will be followed for several years after surgery to monitor outcomes, including 5-year overall survival, disease-free survival, tumor recurrence, and quality of life. Additional assessments will include pain scores, hospital stay duration, drainage volume, catheterization days, and postoperative complications within 30 days after surgery. The study also evaluates operative details and short-term recovery measures to compare the two surgical techniques comprehensively.
CONDITIONS
Brief Title
Robot-assisted vs VATS for Thymoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old at the time of consent, any gender
- Diagnosed clinically with thymic epithelial tumor based on chest CT, MR, and blood tests, with or without myasthenia gravis symptoms
- Need to undergo thymectomy surgery
- Clinical stage I to IIIA according to AJCC-UICC TNM staging
- Maximum tumor diameter less than 5 cm
- Eastern Cooperative Oncology Group (ECOG) physical condition score of 0 or 1
- No prior anti-thymoma treatments such as chemotherapy or radiotherapy
- Preoperative major organ function within specified limits for bone marrow, coagulation, liver, and kidney function
- Willing and able to participate in robot-assisted or thoracoscopic thymectomy and comply with follow-up
You will not qualify if you...
- Experiencing myasthenia gravis crisis
- Prior mediastinal or cardiac surgery
- Body mass index (BMI) of 30 or higher
- Severe liver or kidney dysfunction exceeding specified limits
- Severe chronic lung diseases including COPD, asthma, or interstitial lung disease
- Uncontrolled heart, kidney, gastrointestinal, infectious diseases, or other complications
- Presence of other malignant tumors or hematological diseases
- Chronic pain or preoperative use of opioid analgesics
- Thoracic deformities such as pectus carinatum or pectus excavatum
- Mental disorders such as anxiety
- Pregnant or breastfeeding women
- Currently participating in other interventional clinical studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Postoperative in-hospital stay up to 30 days
Participants undergo either robot-assisted thoracoscopic surgery (RATS) or video-assisted thoracoscopic surgery (VATS) for thymoma. After surgery, participants receive immediate post-operative care including chest tube and catheter placement.
Daily hospital visits during hospital stay
Duration - Up to 5 years after surgery
Participants are monitored for short-term and long-term outcomes including survival, quality of life, pain, complications, and tumor recurrence.
Follow-up visits at 1 year and periodic assessments up to 5 years
Trial Site Locations
Total: 2 locations
1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
2
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang, China
Not Yet Recruiting
Research Team
J
Juemin Yu
D
Deping Zhao, MD,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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