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

Study Overview
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Brief Summary
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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.

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

Conditions
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Thymectomy, Myasthenia Gravis

Intervention / Treatment
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* Procedure: 3-Hole subxiphorid and subcostal approach
* Procedure: Trans sternal approach
* Procedure: VATS approach


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3-Hole subxiphorid and subcostal approach<br>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. | Procedure: 3-Hole subxiphorid and subcostal approach<br>* 3-Hole subxiphorid and subcostal approach anterior mediastinum tumor resection<br>* Other names: 3-Hole approach;|
| Experimental: Trans sternal approach<br> | Procedure: Trans sternal approach<br>* Trans sternal approach anterior mediastinum tumor resection<br>* Other names: median sternotomy;|
| Experimental: VATS approach<br> | Procedure: VATS approach<br>* Video-assisted thoracoscope anterior mediastinum tumor resection<br>* Other names: Video-assisted thoracoscope;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Duration of operation |  | Participants will be followed for the duration of hospital stay, an expected average of 5 days | 
| Mortality rate | Death caused by operation or complications | up to 10 years | 
| Overall survival | From randomization to any cause of death | up to 10 years | 
| Quality of life | Measured by EORTC QLQ-C30 (version 3) scale | up to 10 years after operation | 
| Number of Participants with Adverse Events |  | up to 8weekss afte operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3-Hole approach, extended thymectomy, myasthenia gravis, safety, effectiveness