The Curative Effect of Extended Thymectomy Performed Through Subxiphoid-right VATS Approach With Elevation of Sternum

Myasthenia Gravis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03613272
• Other study ID #: K18-137
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2021
• Source: Tongji University
• Contact: Jiang Fan, MD,PhD
• Phone: +86 13764271861
• Email: drjiangfan[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. MG with thymic hyperplasia, thymoma or other anterior mediastinum disease

2. Masaoka staging?-?

3. Patients with normal cardio-pulmonary function before operation, BMI<30

Exclusion Criteria:

1. Unable to tolerate surgery

2. Masaoka staging ?-?

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

Related Conditions & MeSH terms

• Mediastinal Neoplasms
• Mediastinal Tumor
• Myasthenia Gravis
• Thymoma
• Thymus Neoplasms

Intervention

Procedure:
• Subxiphoid approach extended thymectomy by VATS
Extended thymectomy performed through the subxiphoid-right VATS approach with double elevation of the sternum
• Intercostal approach extended thymectomy by VATS
Extended thymectomy performed through the traditional intercostal VATS approach

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Hainan Medical University	Haikou	Hainan
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai
China	Shaoxing Center Hospital	Shaoxing	Zhejiang
China	Shanxi Provincial Cancer Hospital	Taiyuan	Shanxi
China	Taizhou Center Hospital (Taizhou Unoversity Hospital)	Taizhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Jiang Fan

Country where clinical trial is conducted

China, 

References & Publications (5)

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. Review. — View 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: 1 — View 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. — View 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 eleva — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resection rate of thymus tissue	The thymus tissue resection rate was calculated by comparing the preoperative and postoperative CT images.	1 month
Primary	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
Primary	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
Primary	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
Primary	Disease-free survival	From grouping to the recurrence of disease or the time of death due to disease progression.	Up to 5 years
Primary	Recurrence rate	The rate of patients recurrence after surgery	Up to 5 years
Secondary	Mortality rate	Death caused by operation or complications	Up to 5 years
Secondary	Overall survival	From grouping to any cause of death	Up to 5 years
Secondary	Operation time	Time of the surgical operation	1 week
Secondary	Length of stay	The time of the patients in hospital	1 month
Secondary	Complication rate	The incidence rate of postoperative complications in the two groups	1 month
Secondary	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