Cavernous Transformation of Portal Vein： Etiology, Diagnosis, Management and Prognosis

October 28, 2015 updated by: Zaibo Jiang, Sun Yat-sen University
To observe the etiology, diagnosis, management and prognosis of cavernous transformation of portal vein.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To observe the etiology, diagnosis, management and prognosis of cavernous transformation of portal vein.

We perform Montelukast (10mg, q.d., p.o.) fot the treatment of symptomatic cavernous transformation of portal vein and to observe the efficacy such as the decrease of the volume of ascites and hydrothorax.

Study Type

Observational

Enrollment (Anticipated)

150

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

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • Department of Radiology
        • Contact:

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

2 years to 76 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with CTPV

Description

Inclusion Criteria:

  • All patients with CTPV.

Exclusion Criteria:

  • Patients with known severe dysfunction of heart, lung, brain, kidney and other vital organs.

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CTPV without Montelukast
Patients with CTPV do not receive the treatment of Montelukast.
CTPV treated with Montelukast
Patients with CTPV treated with Montelukast (10mg, q.d., p.o.).
Drug: Montelukast
Montelukast (10mg, q.d., p.o.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ascites Volume (mL)
Time Frame: 6 month
Ascites measured by CT scanning or ultrasound (If the patients had the history of ascites before)
6 month
Hydrothorax Volume (mL)
Time Frame: 6 month
Hydrothorax measured by CT scanning or ultrasound (If the patients had the history of hydrothorax before)
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Chair: Zaibo Jiang, MD, Sun Yat-sen University

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

October 1, 2010

Primary Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

July 16, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Estimate)

October 29, 2015

Last Update Submitted That Met QC Criteria

October 28, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTPVDORNO3HSYSU

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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