- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01707862
Surgery for Intravenous Leiomyomatosis (SIVL)
October 15, 2012 updated by: Li Yang
Surgical Management of Intravenous Leiomyomatosis With Intracardiac Extension: Our Experience and Outcomes
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.
Study Overview
Status
Completed
Conditions
Detailed Description
All patients underwent surgical management.
Clinical data were obtained from medical reports.
Following-up was made through email and telephone.
Study Type
Observational
Enrollment (Actual)
6
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China
- Institute of Cardiovascular Disease
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Genetal Hospital Beijing Military Region, First class, Institute of Cardiovascular Disease
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 1997
Primary Completion (ACTUAL)
April 1, 2012
Study Completion (ACTUAL)
October 1, 2012
Study Registration Dates
First Submitted
October 14, 2012
First Submitted That Met QC Criteria
October 15, 2012
First Posted (ESTIMATE)
October 16, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
October 16, 2012
Last Update Submitted That Met QC Criteria
October 15, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GHBeijing-20121012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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