A Prospective Multicenter Comparative Study of the Curative Effect of Extended Thymectomy Performed Through the Subxiphoid VATS Approach With Double Elevation of the Sternum Versus Intercostal VATS Approach
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Disease-free survival
研究概览
简要总结
Extended thymectomy is the main treatment for thymoma and other anterior mediastinal diseases. Video-assisted thoracic surgery(VATS) plays an important role in the surgery of extended thymectomy. Now, VATS thymectomy through intercostal approach has been the commonly used minimally invasive surgical procedure for thymus surgery and is applied worldwide. But the intercostal approach may cause residue of thymus tissue and chronic pain. In 2013, doctor Marcin Zielin´ski form Poland reported a new technique of minimally invasive extended thymectomy performed through the VATS approach with double elevation of the sternum. And their early results proved this technique is probably the least invasive and the most complete technique of VATS thymectomy with excellent cosmetic results. Until now, doctor Jiang Fan form Shanghai Pulmonary Hospital has performed 50 cases extended thymectomy through the subxiphoid approach with double elevation of the sternum by VATS. This study is designed to compare the curative effect between this new method and traditional intercostal VATS.
详细描述
This study is a prospective multicentre cohort study.The main study content is comparative study of the curative effect of extended thymectomy performed through the subxiphoid-right video-thoracoscopic approach with double elevation of the sternum versus intercostal video-thoracoscopic approach, divided into subxiphoid and intercostal groups. Communicating with the surgeon and patients who meet the inclusion criteria, decide whether to enter the subxiphoid or intercostal group. Subxiphoid group with subxiphoid-right video-thoracoscopic approach under double elevation of the sternum in extended thymectomy , intercostal group with traditional intercostal video-assisted thoracoscopic surgery in extended thymectomy. By collecting personal information of two groups of patients and the corresponding observation indicators to analyze whether the subxiphoid-right VATS approach with double elevation of the sternum is the least invasive and the most complete technique of VATS thymectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MG with thymic hyperplasia, thymoma or other anterior mediastinum disease
- •Masaoka stagingⅠ-Ⅱ
- •Patients with normal cardio-pulmonary function before operation, BMI<30
排除标准
- •Unable to tolerate surgery
- •Masaoka staging Ⅲ-Ⅳ
- •Patients who have undergone previous surgery or radiotherapy
- •Myasthenia crisis
- •Chronic pain or using opioid analgesics before surgery
- •Preoperative mental disorders such as excessive anxiety
- •Patients who underwent previous mediastinal surgery or cardiac surgery
- •Patients with thoracic deformity
结局指标
主要结局
Disease-free survival
时间窗: Up to 5 years
From grouping to the recurrence of disease or the time of death due to disease progression.
Recurrence rate
时间窗: Up to 5 years
The rate of patients recurrence after surgery
Resection rate of thymus tissue
时间窗: 1 month
The thymus tissue resection rate was calculated by comparing the preoperative and postoperative CT images.
Acute Pain Score
时间窗: 24 hours
Visual analogue score (VAS-score) is to asses the development of acute pain after surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain " in patients 24 hours after operation.
Myasthenia Gravis remission rate
时间窗: 1 year
The Quantitative Myasthenia Gravis scale (QMG) is used. It includes 13 items, such as eyelid ptosis, diplopia, eyelid closure, speech, swallowing, vital capacity, lift, grip and lower extremity elevation. QMG can evaluate myasthenia, and total score of the scale is from 0 (no myasthenia) to 39 (the most severe myasthenia). If the difference between the two assessment scores is greater than 3.5, it is considered that the symptoms of myasthenia gravis relieved.
Life Quality of Patients
时间窗: 6 months
The EuroQol 5 Dimensions (EQ-5D) is used. EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. EQ-5D includes self-reported quality of life, where 0 is the worst and 100 is the best imaginable health state.
次要结局
- Mortality rate(Up to 5 years)
- Operation time(1 week)
- Length of stay(1 month)
- Overall survival(Up to 5 years)
- Complication rate(1 month)
- Chronic Pain Score(6 months)
研究者
Jiang Fan
Chief physician
Tongji University