Robot-assisted vs VATS for Thymoma

Not Applicable

Recruiting

• Conditions: Thymoma
• Interventions: Procedure: VATS for Thymectomy; Procedure: RATS for Thymectomy

• Registration Number: NCT06029621
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

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.

Study Timeline

• Study First Submitted: 2023-08-28
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-08
• Study Start: 2023-11-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-29
• Primary Completion: 2030-09-19
• Study Completion: 2030-09-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 304

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VATS for Thymectomy	VATS for Thymectomy	The main operation principles and procedures of the operation are basically similar to those of the RATS and are completed under video-assisted thoracoscopic surgery.
RATS for Thymectomy	RATS for Thymectomy	The 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.

Primary Outcome Measures

Name	Time	Method
5-year overall survival (OS)	5 year after surgery	OS at 5 year after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China

The Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Zhejiang, China