The Safety and Efficacy of "3-Hole" Subxiphorid Approach in the Treatment of Anterior Mediastinal Tumor
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: "3-Hole" subxiphorid and subcostal approach 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
"3-Hole" subxiphorid and subcostal approach anterior mediastinum tumor resection
Other Names:
|
| Experimental: Trans sternal approach
|
Procedure: Trans sternal approach
Trans sternal approach anterior mediastinum tumor resection
Other Names:
|
| Experimental: VATS approach
|
Procedure: VATS approach
Video-assisted thoracoscope anterior mediastinum tumor resection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Duration of operation [Participants will be followed for the duration of hospital stay, an expected average of 5 days]
- 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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tangdu hospital | Xi'an | Shaanxi | China | 710038 |
Sponsors and Collaborators
- Tang-Du Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TangduH717544