The Curative Effect of Extended Thymectomy Performed Through Subxiphoid-right VATS Approach With Elevation of Sternum

Jiang Fan

Status: Unknown

Conditions: Thymoma; Myasthenia Gravis; Mediastinal Tumor

Treatments: Procedure: Subxiphoid approach extended thymectomy by VATS; Procedure: Intercostal approach extended thymectomy by VATS

Study type: Interventional

Funder types: Other

Identifiers

NCT03613272

K18-137

Details and patient eligibility

About

Extended thymectomy is the main treatment for thymoma and other anterior mediastinal diseases. Video-assisted thoracic surgery(VATS) plays an important role in the surgery of extended thymectomy. Now, VATS thymectomy through intercostal approach has been the commonly used minimally invasive surgical procedure for thymus surgery and is applied worldwide. But the intercostal approach may cause residue of thymus tissue and chronic pain. In 2013, doctor Marcin Zielin´ski form Poland reported a new technique of minimally invasive extended thymectomy performed through the VATS approach with double elevation of the sternum. And their early results proved this technique is probably the least invasive and the most complete technique of VATS thymectomy with excellent cosmetic results. Until now, doctor Jiang Fan form Shanghai Pulmonary Hospital has performed 50 cases extended thymectomy through the subxiphoid approach with double elevation of the sternum by VATS. This study is designed to compare the curative effect between this new method and traditional intercostal VATS.

Full description

This study is a prospective multicentre cohort study.The main study content is comparative study of the curative effect of extended thymectomy performed through the subxiphoid-right video-thoracoscopic approach with double elevation of the sternum versus intercostal video-thoracoscopic approach, divided into subxiphoid and intercostal groups. Communicating with the surgeon and patients who meet the inclusion criteria, decide whether to enter the subxiphoid or intercostal group. Subxiphoid group with subxiphoid-right video-thoracoscopic approach under double elevation of the sternum in extended thymectomy , intercostal group with traditional intercostal video-assisted thoracoscopic surgery in extended thymectomy. By collecting personal information of two groups of patients and the corresponding observation indicators to analyze whether the subxiphoid-right VATS approach with double elevation of the sternum is the least invasive and the most complete technique of VATS thymectomy.

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. MG with thymic hyperplasia, thymoma or other anterior mediastinum disease
2. Masaoka stagingⅠ-Ⅱ
3. Patients with normal cardio-pulmonary function before operation, BMI<30

Exclusion criteria

1. Unable to tolerate surgery
2. Masaoka staging Ⅲ-Ⅳ
3. Patients who have undergone previous surgery or radiotherapy
4. Myasthenia crisis
5. Chronic pain or using opioid analgesics before surgery
6. Preoperative mental disorders such as excessive anxiety
7. Patients who underwent previous mediastinal surgery or cardiac surgery
8. Patients with thoracic deformity

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Subxiphoid approach

Experimental group

Description:

The patients in subxiphoid group will get subxiphoid approach extended thymectomy by VATS. Whole dissection was performed through a 4 to 7cm transverse subxiphoid incision, and a single 5-mm port was inserted into the right chest cavity for the video thoracoscope and subsequently for the chest tube. The sternum was elevated with two hooks connected to the sternal frame. The lower hook was inserted through the subxiphoid incision, and the superior hook was inserted percutaneously after the mediastinal tissue including the major mediastinal vessels was dissected from the inner surface of the sternum. The thymus and fatty tissue of the anterior mediastinum and the aorta-pulmonary window was completely removed.

Treatment:

Procedure: Subxiphoid approach extended thymectomy by VATS

Intercostal approach

Experimental group

Description:

The patients in intercostal group will get intercostal approach extended thymectomy by VATS.

Treatment:

Procedure: Intercostal approach extended thymectomy by VATS