Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Procedure

Thymectomy Clinical Trial

Official title:

Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Thymectomy: Short- Term and Long- Term Results

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04223466
• Other study ID #: Subxiphoid ZYP1
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: December 31, 2027

Study information

• Verified date: November 2022
• Source: The Second Hospital of Shandong University
• Contact: Yunpeng Zhao
• Phone: +8618766188692
• Email: zyp_baggio[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Surgerys used in thymectomy for myasthenia gravis and anterior mediastinal tumours have become much less invasive in recent years. In our study, the surgical technique which resected the thymus below the xiphoid process and the technique which was regarded as conventional video- assisted thoracoscopic surgery (VATS) thymectomy was compared.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Thymoma with or without myasthenia gravis;

2. Generalized myasthenia gravis not sensitive to conservative medicine treatment;

3. Good cardiopulmonary function.

Exclusion Criteria:

1. Cardiopulmonary function can't bear surgery;

2. Generalized myasthenia gravis with MuSK(+).

Related Conditions & MeSH terms

• Thymectomy

Intervention

Procedure:
• Subxiphoid surgery procedure
Subxiphoid procedure for thymectomy
• VATS surgery procedure
VATS procedure for thymectomy

Locations

Country	Name	City	State
China	Yunpeng	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale of postoperative pain	in score	within 3 days
Primary	Operation time	in minutes	one day
Primary	The amount of blood loss	in milliliter	one day
Primary	Duration of drainage	in days	with 7 days
Primary	Duration of hospital stay	in days	with 7 days
Secondary	Complete remission rates	Complete remission rates after 5 year follow-up of thymectomy for myasthenia gravis	5 years
Secondary	Recurrence rate	Recurrence rate after 5 year follow-up of thymectomy for thymoma	5 years
Secondary	Overall survival	Overall survival in rate	within 10 years