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

Phase 2

Recruiting

• Conditions: Myasthenia Gravis; Thymectomy

• Registration Number: NCT02317224
• Lead Sponsor: Tang-Du Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-11-26
• Status Verified: 2014-12
• Study First Submitted QC: 2014-12-10
• Last Update Submitted: 2014-12-10
• Study First Posted: 2014-12-15
• Last Update Posted: 2014-12-15
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• MG with thymic hyperplasia, thymoma or other anterior mediastinum disease
• Masaoka stagingⅠ-Ⅱ
• Thymoma without MG
• Mass diameter <10cm
• Inform Consent Form is signed

Exclusion Criteria

• Unable to tolerate surgery
• myasthenic crisis
• Masaoka staging Ⅲ-Ⅳ
• Patients who have undergone previous surgery or radiotherapy
• pregnancy , breastfeeding or younger than 18 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Tangdu hospital; 🇨🇳 Xi'an, Shaanxi, China