NCT02505113

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

10.2 years

First QC Date

July 16, 2015

Last Update Submit

October 28, 2015

Conditions

Portal Vein, Cavernous Transformation Of

Keywords

Portal Vein, Cavernous Transformation OfHypertension, Portal

Outcome Measures

Primary Outcomes (2)

  • Ascites Volume (mL)

    Ascites measured by CT scanning or ultrasound (If the patients had the history of ascites before)

    6 month

  • Hydrothorax Volume (mL)

    Hydrothorax measured by CT scanning or ultrasound (If the patients had the history of hydrothorax before)

    6 month

Study Arms (2)

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

Interventions

MontelukastDRUG

Montelukast (10mg, q.d., p.o.)

CTPV treated with Montelukast

Eligibility Criteria

Age1 Year - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with CTPV

You may qualify if:

  • All patients with CTPV.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiology

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Portal Vein, Cavernous Transformation OfHypertension, Portal

Interventions

montelukast

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Zaibo Jiang, MD

    Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Zaibo Jiang, MD

CONTACT

+86 020 85253416jiangzaibo@aliyun.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Radiology, The Third Affiliated Hospital, Sun Yat-Sen University

Study Record Dates

First Submitted

July 16, 2015

First Posted

July 22, 2015

Study Start

October 1, 2010

Primary Completion

December 1, 2020

Last Updated

October 29, 2015

Record last verified: 2015-10

Locations

CN(1)