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

Tang-Du Hospital

Status and phase: Enrolling; Phase 2

Conditions: Myasthenia Gravis; Thymectomy

Treatments: Procedure: Trans sternal approach; Procedure: VATS approach; Procedure: "3-Hole" subxiphorid and subcostal approach

Study type: Interventional

Funder types: Other

Identifiers

NCT02317224

TangduH717544

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

"3-Hole" subxiphorid and subcostal approach

Experimental group

Description:

The patient were in the supine position with legs apart at about 45°, made a 2.0 cm incision below xiphoid process as the observation hole. Then made two 0.5cm operation holes along bilateral rib arch at midclavicular line, two trocars were inserted into the two holes under the guidance of B-ultrasound.After that, carbon dioxide was pumped into the anterior mediastinum, the pressure was maintained at 8 mmH2O, ultrasound scalpel and a grasping forceps were inserted through the operating ports respectively. Retrosternal space including bilateral lower poles of thymus, internal mammary arteries and phrenic nerves were exposed by both blunt and sharp dissection. Then ultrasound scalpel were used to separate the thymus and its surrounding fat tissue, cut off thymic veins by ultrasound scalpel.For patients with myasthenia gravis, bilateral mediastinal pleurae and the affected adipose tissues had been thoroughly removed.

Treatment:

Procedure: "3-Hole" subxiphorid and subcostal approach

Trans sternal approach

Experimental group

Treatment:

Procedure: Trans sternal approach

VATS approach

Experimental group

Treatment:

Procedure: VATS approach