Robot-assisted vs VATS for Thymoma

Thymoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06029621
• Other study ID #: STAR006
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: September 19, 2030

Study information

• Verified date: February 2024
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Juemin Yu
• Phone: +8615927548511
• Email: yujm96[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. completion date: September 19, 2030
• Est. primary completion date: September 19, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Thymoma
• Thymus Neoplasms

Intervention

Procedure:
• RATS for Thymectomy
a minimally invasive surgical type for Thymoma: RATS
• VATS for Thymectomy
a minimally invasive surgical type for Thymoma: VATS

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year overall survival (OS)	OS at 5 year after surgery	5 year after surgery
Secondary	Pain score	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	at 1 year after surgery
Secondary	quality of life (QOL) at 1 year by EORTC QLQ-C30	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	at 1 year after surgery
Secondary	quality of life (QOL) at 1 year by EQ-5D	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).	at 1 year after surgery
Secondary	R0 rate	R0 radical rate	postoperative in-hospital stay up to 30 days
Secondary	operative time	the time of operation	Intraoperative
Secondary	blood loss	blood loss in the operation	Intraoperative
Secondary	conversion rate	the rate of conversion to open surgery in the operation	Intraoperative
Secondary	length of hospital stay (LOS)	length of stay in hospitalization	postoperative in-hospital stay up to 30 days
Secondary	Catheterization days	The interval days from the completion of catheter insertion to the removal of the thoracic tube	postoperative in-hospital stay up to 30 days
Secondary	Volume of drainage	Volume of drainage from the completion of catheter insertion to the removal of the thoracic tube	postoperative in-hospital stay up to 30 days
Secondary	postoperative complications	mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula	postoperative in-hospital stay up to 30 days
Secondary	30-day mortality	30-day mortality after surgery	postoperative in-hospital stay up to 30 days
Secondary	30-day readmission rate after surgery	Rate of readmission due to postoperative complications	postoperative in-hospital stay up to 30 days
Secondary	5-year disease-free survival (DFS)	DFS at 5 year after surgery	5 year after surgery
Secondary	Tumor recurrence rate	The rate of recurrence of thymoma in patients after surgery	5 year after surgery