Surgery for Intravenous Leiomyomatosis (SIVL)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Li Yang, General Hospital of Beijing PLA Military Region

ClinicalTrials.gov Identifier:

NCT01707862

First received: October 14, 2012

Last updated: October 15, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 14, 2012

Last Updated Date

October 15, 2012

Start Date ^ICMJE

March 1997

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01707862 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Surgery for Intravenous Leiomyomatosis

Official Title ^ICMJE

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

Brief 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.

Detailed Description

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

From March 1997 to June 2011, 6 women patients were admitted to our hospital with intravenous leiomyomatosis with intracardiac extension.

Condition ^ICMJE

Leiomyomatosis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2012

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01707862

Other Study ID Numbers ^ICMJE

GHBeijing-20121012

Has Data Monitoring Committee

Yes

Responsible Party

Li Yang, General Hospital of Beijing PLA Military Region

Study Sponsor ^ICMJE

Li Yang

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Genetal Hospital Beijing Military Region, First class

Institute of Cardiovascular Disease

Information Provided By

General Hospital of Beijing PLA Military Region

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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