Clinical trial NCT03613272: The Curative Effect of Extended Thymectomy Performed Through Subxiphoid-right VATS Approach With Elevation of Sternum
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thymoma
Myasthenia Gravis
Mediastinal Tumor
Keywords: thymoma
thymectomy
Myasthenia Gravis
VATS
subxiphoid
elevation of the sternum
curative effect
Lead sponsor: Tongji University
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. MG with thymic hyperplasia, thymoma or other anterior mediastinum disease
2. Masaoka stagingⅠ-Ⅱ
3. Patients with normal cardio-pulmonary function before operation, BMI\<30

Exclusion Criteria:

1. Unable to tolerate surgery
2. Masaoka staging Ⅲ-Ⅳ
3. Patients who have undergone previous surgery or radiotherapy
4. Myasthenia crisis
5. Chronic pain or using opioid analgesics before surgery
6. Preoperative mental disorders such as excessive anxiety
7. Patients who underwent previous mediastinal surgery or cardiac surgery
8. Patients with thoracic deformity

Primary outcomes:
measure: Resection rate of thymus tissue
timeFrame: 1 month
measure: Acute Pain Score
timeFrame: 24 hours
measure: Life Quality of Patients
timeFrame: 6 months
measure: Myasthenia Gravis remission rate
timeFrame: 1 year
measure: Disease-free survival
timeFrame: Up to 5 years
measure: Recurrence rate
timeFrame: Up to 5 years
Secondary outcomes:
measure: Mortality rate
timeFrame: Up to 5 years
measure: Overall survival
timeFrame: Up to 5 years
measure: Operation time
timeFrame: 1 week
measure: Length of stay
timeFrame: 1 month
measure: Complication rate
timeFrame: 1 month
measure: Chronic Pain Score
timeFrame: 6 months
Other outcomes:
Locations:
city: Haikou
country: China
facility: The Second Affiliated Hospital of Hainan Medical University
state: Hainan
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
state: Shanxi
city: Shaoxing
country: China
facility: Shaoxing Center Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Center Hospital (Taizhou Unoversity Hospital)
state: Zhejiang
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.