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UnknownNCT03613272

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

A Prospective Multicenter Comparative Study of the Curative Effect of Extended Thymectomy Performed Through the Subxiphoid VATS Approach With Double Elevation of the Sternum Versus Intercostal VATS Approach

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
200 (estimated)
Sponsor
Jiang Fan · Academic / Other
Sex
All
Age
20 Years – 70 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
PROCEDURESubxiphoid approach extended thymectomy by VATSExtended thymectomy performed through the subxiphoid-right VATS approach with double elevation of the sternum
PROCEDUREIntercostal approach extended thymectomy by VATSExtended thymectomy performed through the traditional intercostal VATS approach

Timeline

Start date
2018-07-01
Primary completion
2023-07-01
Completion
2023-12-01
First posted
2018-08-03
Last updated
2021-05-07

Locations

5 sites across 1 country: China

Source: ClinicalTrials.gov record NCT03613272. Inclusion in this directory is not an endorsement.