The Curative Effect of Extended Thymectomy Performed Through Subxiphoid-right VATS Approach With Elevation of Sternum
- Conditions
- ThymomaMyasthenia GravisMediastinal Tumor
- Interventions
- Procedure: Intercostal approach extended thymectomy by VATSProcedure: Subxiphoid approach extended thymectomy by VATS
- Registration Number
- NCT03613272
- Lead Sponsor
- Jiang Fan
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- MG with thymic hyperplasia, thymoma or other anterior mediastinum disease
- Masaoka stagingⅠ-Ⅱ
- Patients with normal cardio-pulmonary function before operation, BMI<30
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intercostal approach Intercostal approach extended thymectomy by VATS The patients in intercostal group will get intercostal approach extended thymectomy by VATS. Subxiphoid approach Subxiphoid approach extended thymectomy by VATS The patients in subxiphoid group will get subxiphoid approach extended thymectomy by VATS. Whole dissection was performed through a 4 to 7cm transverse subxiphoid incision, and a single 5-mm port was inserted into the right chest cavity for the video thoracoscope and subsequently for the chest tube. The sternum was elevated with two hooks connected to the sternal frame. The lower hook was inserted through the subxiphoid incision, and the superior hook was inserted percutaneously after the mediastinal tissue including the major mediastinal vessels was dissected from the inner surface of the sternum. The thymus and fatty tissue of the anterior mediastinum and the aorta-pulmonary window was completely removed.
- Primary Outcome Measures
Name Time Method Disease-free survival Up to 5 years From grouping to the recurrence of disease or the time of death due to disease progression.
Recurrence rate Up to 5 years The rate of patients recurrence after surgery
Resection rate of thymus tissue 1 month The thymus tissue resection rate was calculated by comparing the preoperative and postoperative CT images.
Acute Pain Score 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 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 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.
- Secondary Outcome Measures
Name Time Method Operation time 1 week Time of the surgical operation
Length of stay 1 month The time of the patients in hospital
Mortality rate Up to 5 years Death caused by operation or complications
Overall survival Up to 5 years From grouping to any cause of death
Complication rate 1 month The incidence rate of postoperative complications in the two groups
Chronic Pain Score 6 months Visual analogue score (VAS-score) is to asses the development of chronic pain after surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain " in patients 6 months after operation.
Trial Locations
- Locations (5)
Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, China
Shaoxing Center Hospital
🇨🇳Shaoxing, Zhejiang, China
Taizhou Center Hospital (Taizhou Unoversity Hospital)
🇨🇳Taizhou, Zhejiang, China
The Second Affiliated Hospital of Hainan Medical University
🇨🇳Haikou, Hainan, China
Shanxi Provincial Cancer Hospital
🇨🇳Taiyuan, Shanxi, China