Comparison of Short-term and Longterm Outcomes Between Robot-assisted Thoracoscopy and Television-assisted Thoracoscopy Surgery Forthymoma : a Multicenter, Prospective, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 304
- 试验地点
- 2
- 主要终点
- 5-year overall survival (OS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
no masking
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •) 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.
排除标准
- •) 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.
研究组 & 干预措施
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.
干预措施: RATS for Thymectomy (Procedure)
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.
干预措施: VATS for Thymectomy (Procedure)
结局指标
主要结局
5-year overall survival (OS)
时间窗: 5 year after surgery
OS at 5 year after surgery
次要结局
- R0 rate(postoperative in-hospital stay up to 30 days)
- blood loss(Intraoperative)
- conversion rate(Intraoperative)
- length of hospital stay (LOS)(postoperative in-hospital stay up to 30 days)
- Catheterization days(postoperative in-hospital stay up to 30 days)
- 30-day mortality(postoperative in-hospital stay up to 30 days)
- quality of life (QOL) at 1 year by EQ-5D(at 1 year after surgery)
- 5-year disease-free survival (DFS)(5 year after surgery)
- Tumor recurrence rate(5 year after surgery)
- Pain score(at 1 year after surgery)
- operative time(Intraoperative)
- postoperative complications(postoperative in-hospital stay up to 30 days)
- 30-day readmission rate after surgery(postoperative in-hospital stay up to 30 days)
- quality of life (QOL) at 1 year by EORTC QLQ-C30(at 1 year after surgery)
- Volume of drainage(postoperative in-hospital stay up to 30 days)
研究者
Deping Zhao
Administrative Director of Thoracic Surgery Department
Shanghai Pulmonary Hospital, Shanghai, China