An interventional study of Subxiphoid approach extended thymectomy by VATS and Intercostal approach extended thymectomy by VATS in Thymoma, Myasthenia Gravis and Mediastinal Tumor, sponsored by Jiang Fan. Status unknown at 5 sites in China. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-05-07.
Sponsored by Jiang Fan · Not applicable, Interventional, and Treatment
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.
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.
324 studies on the registry are indexed under Myasthenia Gravis; 146 are open to participants now.
This study's planned enrollment of 200 is above the median of 44 across 212 interventional studies indexed under Myasthenia Gravis.
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Exclusion Criteria:
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.
Procedure: Subxiphoid approach extended thymectomy by VATS
The patients in intercostal group will get intercostal approach extended thymectomy by VATS.
Procedure: Intercostal approach extended thymectomy by VATS
Extended thymectomy performed through the subxiphoid-right VATS approach with double elevation of the sternum
Extended thymectomy performed through the traditional intercostal VATS approach
Resection rate of thymus tissue
The thymus tissue resection rate was calculated by comparing the preoperative and postoperative CT images.
Time frame: 1 month
Acute Pain Score
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.
Time frame: 24 hours
Life Quality of Patients
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.
Time frame: 6 months
Myasthenia Gravis remission rate
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.
Time frame: 1 year
Disease-free survival
From grouping to the recurrence of disease or the time of death due to disease progression.
Time frame: Up to 5 years
Recurrence rate
The rate of patients recurrence after surgery
Time frame: Up to 5 years
Mortality rate
Death caused by operation or complications
Time frame: Up to 5 years
Overall survival
From grouping to any cause of death
Time frame: Up to 5 years
Operation time
Time of the surgical operation
Time frame: 1 week
Length of stay
The time of the patients in hospital
Time frame: 1 month
Complication rate
The incidence rate of postoperative complications in the two groups
Time frame: 1 month
Chronic Pain Score
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.
Time frame: 6 months
Plan to share: Undecided
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