The Safety and Efficacy of "3-Hole" Subxiphorid Approach in the Treatment of Anterior Mediastinal Tumor

Myasthenia Gravis Clinical Trial

— 3-Hole  

Official title:

Comparison of Safety and Efficacy Among "3-Hole" Subxiphorid Approach, Trans Sternal Approach and VATS in Surgical Treatment of Anterior Mediastinal Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02317224
• Other study ID #: TangduH717544
• Status: Recruiting
• Phase: Phase 2
• First received: November 26, 2014
• Last updated: December 10, 2014
• Start date: August 2014
• Est. completion date: December 2024

Study information

• Verified date: December 2014
• Source: Tang-Du Hospital
• Contact: Yong-an Zhou, MD
• Phone: +86 029 84717544
• Email: zhou.yongan[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Surgery plays an important role in the treatment of anterior mediastinum disease. The major surgical approaches include: cervical approach, mid-sternal approach, cervical combined mid-sternal approach and video-assisted thoracoscopic approach. The cervical approach is rarely adopted because of its restricted visual field. The cervical combined mid-sternal approach have a broader field of vision, given this advantage, the surgeon can remove the thymus and its surrounding fat tissue more thoroughly. But the trauma of this approach is much larger, and the postoperative complication is also a serious problem. The video-assisted thoracoscope is often adopted by left or right approach, this minimally invasive procedure can not remove anterior mediastinum fat thoroughly. In clinical practice, the investigators designed a new method named "3-Hole" subxiphoid approach. This study is designed to compare the safety and validity between this new method and others.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• MG with thymic hyperplasia, thymoma or other anterior mediastinum disease

• Masaoka staging?-?

• Thymoma without MG

• Mass diameter <10cm

• Inform Consent Form is signed

Exclusion Criteria:

• Unable to tolerate surgery

• myasthenic crisis

• Masaoka staging ?-?

• Patients who have undergone previous surgery or radiotherapy

• pregnancy , breastfeeding or younger than 18 years old

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mediastinal Neoplasms
• Myasthenia Gravis
• Thymectomy

Intervention

Procedure:
• "3-Hole" subxiphorid and subcostal approach
"3-Hole" subxiphorid and subcostal approach anterior mediastinum tumor resection
• Trans sternal approach
Trans sternal approach anterior mediastinum tumor resection
• VATS approach
Video-assisted thoracoscope anterior mediastinum tumor resection

Locations

Country	Name	City	State
China	Tangdu hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of bleeding	Measured by the difference between the wet weight and dry weight of surgical gauze	Participants will be followed for the duration of hospital stay, an expected average of 5 days	Yes
Primary	Rate of conversions to thoracotomy	Only in "3-Hole" subxiphorid group and VATS group	Participants will be followed for the duration of hospital stay, an expected average of 5 days	Yes
Primary	Duration of operation		Participants will be followed for the duration of hospital stay, an expected average of 5 days	Yes
Primary	Mortality rate	Death caused by operation or complications	up to 10 years	Yes
Primary	Overall survival	From randomization to any cause of death	up to 10 years	Yes
Primary	Quality of life	Measured by EORTC QLQ-C30 (version 3) scale	up to 10 years after operation	Yes
Primary	Number of Participants with Adverse Events		up to 8weekss afte operation	Yes