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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subxiphoid approach | Experimental | 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. |
|
| Intercostal approach | Experimental | The patients in intercostal group will get intercostal approach extended thymectomy by VATS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subxiphoid approach extended thymectomy by VATS | Procedure | Extended thymectomy performed through the subxiphoid-right VATS approach with double elevation of the sternum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resection rate of thymus tissue | The thymus tissue resection rate was calculated by comparing the preoperative and postoperative CT images. | 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. | 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. | 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. | 1 year |
| Disease-free survival | From grouping to the recurrence of disease or the time of death due to disease progression. | Up to 5 years |
| Recurrence rate | The rate of patients recurrence after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate | Death caused by operation or complications | Up to 5 years |
| Overall survival | From grouping to any cause of death | Up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang Fan, MD，PhD | Contact | +86 13764271861 | drjiangfan@yahoo.com | |
| Nan Song, MD | Contact | +86 18016224489 | lnsongnan@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Hainan Medical University | Recruiting | Haikou | Hainan | 570100 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23761413 | Result | Zielinski M, Czajkowski W, Gwozdz P, Nabialek T, Szlubowski A, Pankowski J. Resection of thymomas with use of the new minimally-invasive technique of extended thymectomy performed through the subxiphoid-right video-thoracoscopic approach with double elevation of the sternum. Eur J Cardiothorac Surg. 2013 Aug;44(2):e113-9; discussion e119. doi: 10.1093/ejcts/ezt224. Epub 2013 Jun 12. | |
| 20117014 |
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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.
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| Intercostal approach extended thymectomy by VATS | Procedure | Extended thymectomy performed through the traditional intercostal VATS approach |
|
| Up to 5 years |
| Operation time | Time of the surgical operation | 1 week |
| Length of stay | The time of the patients in hospital | 1 month |
| Complication rate | The incidence rate of postoperative complications in the two groups | 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. | 6 months |
| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
|
| Shanxi Provincial Cancer Hospital | Recruiting | Taiyuan | Shanxi | 030000 | China |
|
| Shaoxing Center Hospital | Recruiting | Shaoxing | Zhejiang | 312000 | China |
|
| Taizhou Center Hospital (Taizhou Unoversity Hospital) | Recruiting | Taizhou | Zhejiang | 318000 | China |
|
| Result |
| Zielinski M, Hauer L, Hauer J, Pankowski J, Nabialek T, Szlubowski A. Comparison of complete remission rates after 5 year follow-up of three different techniques of thymectomy for myasthenia gravis. Eur J Cardiothorac Surg. 2010 May;37(5):1137-43. doi: 10.1016/j.ejcts.2009.11.029. Epub 2010 Feb 8. |
| 26762737 | Result | Friedant AJ, Handorf EA, Su S, Scott WJ. Minimally Invasive versus Open Thymectomy for Thymic Malignancies: Systematic Review and Meta-Analysis. J Thorac Oncol. 2016 Jan;11(1):30-8. doi: 10.1016/j.jtho.2015.08.004. |
| 11383846 | Result | Takeo S, Sakada T, Yano T. Video-assisted extended thymectomy in patients with thymoma by lifting the sternum. Ann Thorac Surg. 2001 May;71(5):1721-3. doi: 10.1016/s0003-4975(00)02697-7. |
| 26904425 | Result | Hess NR, Sarkaria IS, Pennathur A, Levy RM, Christie NA, Luketich JD. Minimally invasive versus open thymectomy: a systematic review of surgical techniques, patient demographics, and perioperative outcomes. Ann Cardiothorac Surg. 2016 Jan;5(1):1-9. doi: 10.3978/j.issn.2225-319X.2016.01.01. |
| ID | Term |
|---|---|
| D013945 | Thymoma |
| D009157 | Myasthenia Gravis |
| D008479 | Mediastinal Neoplasms |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D008477 | Mediastinal Diseases |
| D013896 | Thoracic Diseases |
| D012140 | Respiratory Tract Diseases |
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