Surgery for Intravenous Leiomyomatosis

Leiomyomatosis Clinical Trial

— SIVL  

Official title:

Surgical Management of Intravenous Leiomyomatosis With Intracardiac Extension: Our Experience and Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707862
• Other study ID #: GHBeijing-20121012
• Status: Completed
• Phase: N/A
• First received: October 14, 2012
• Last updated: October 15, 2012
• Start date: March 1997
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: General Hospital of Beijing PLA Military Region
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Intravenous leiomyomatosis (IVL) with intracardiac extension is a rare benign smooth muscle tumor. Reviewing literature, intracardiac extension of the IVL has been reported in at least 70 cases. Most are individual case reports. Surgical experience is not much. However, different opinion of surgical strategies remain controversial. The purpose of this report is to describe our experience of surgical management for the IVL with intracardiac extension.

Description:

All patients underwent surgical management. Clinical data were obtained from medical reports. Following-up was made through email and telephone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age more than 18 years.

• Tumor markers were all within normal limits.

• Patients underwent surgical management.

• Patients were followed-up for more than 12 months.

Exclusion Criteria:

-Tumor markers were all within abnormal limits

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Leiomyomatosis

Locations

Country	Name	City	State
China	Institute of Cardiovascular Disease	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Li Yang

Country where clinical trial is conducted

China,