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

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02505113
• Collaborator: (none)
• Enrollment: 150
• Location: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Portal Vein, Cavernous Transformation Of	Drug: Montelukast

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 Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Study Start Date: Oct 1, 2010
• Anticipated Primary Completion Date: Dec 1, 2020

Arms and Interventions

Arm	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.)

Outcome Measures

Primary Outcome Measures

1. Ascites Volume (mL) [6 month]

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

2. Hydrothorax Volume (mL) [6 month]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All patients with CTPV.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Radiology	Guangzhou	Guangdong	China	510630

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zaibo Jiang, Department of Radiology, The Third Affiliated Hospital, Sun Yat-Sen University, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT02505113
• Other Study ID Numbers: CTPVDORNO3HSYSU
• First Posted: Jul 22, 2015
• Last Update Posted: Oct 29, 2015
• Last Verified: Oct 1, 2015

• Keywords provided by Zaibo Jiang, Department of Radiology, The Third Affiliated Hospital, Sun Yat-Sen University, Sun Yat-sen University: Portal Vein, Cavernous Transformation Of; Hypertension, Portal
• Additional relevant MeSH terms: Hypertension, Portal; Montelukast

Study Results

No Results Posted as of Oct 29, 2015