Interventional Radiology for the Treatment of Symptomatic Portal Hypertension in Patients With Cavernous Transformation of Portal Vein

July 20, 2015 updated by: Zaibo Jiang, Sun Yat-sen University
To evaluate the values of portosystemic shunt and other interventional radiology approaches for treatment of symptomatic portal hypertension in patients with cavernous transformation of portal vein.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

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, 510000
        • Recruiting
        • Department of Radiology

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

1 year to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients with portal hypertention who have enough image information to confirm cavernous transformation of portal vein.

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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Transhepatic portosystemic shunt
Patients with cavernous transformation of portal vein undergo transhepatic portalsystemic shunt and other interventional radiology treatment
Device: Bare metal stent
Procedure: Transhepatic portosystemic shunt
Portal vein (PV) was punctured with a 22-gauge chiba needle. A 0.018-inch guidewire was advanced through the needle into PV lumen. The needle was exchanged and a 6-French sheath inserted over the wire. Then middle hepatic vein (MHV) was punctured with a 20-gauge reformed needle through the transhepatic sheath. Another 0.018-inch guidewire was advanced through the needle into right internal jugular vein and then snared out of body. A 0.035-inch, 260-cm-long stiff shaft wire was introduced through the transjugular sheath and manipulated into main portal vein (MPV) and then into SMV. The parenchymal tract was dilated with balloon catheter, then one or more bare metal stents and one or more covered stents were inserted to line the parenchymal tract.
Device: 6-French sheath
Device: 22-gauge chiba needle
Device: 260-cm-long stiff shaft wire
Device: Balloon catheter
Device: Covered stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence Rate of Gastrointestinal Bleeding
Time Frame: 1 month
No gastrointestinal bleeding proved by patients' symptoms (If the patients had the history of gastrointestinal bleeding before)
1 month
Ascites Volume (mL)
Time Frame: 1 month
No ascites proved by CT scanning or ultrasound (If the patients had the history of ascites before)
1 month

Collaborators and Investigators

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

Sponsor

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 15, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (ESTIMATE)

July 21, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

July 21, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DORNO3HSYSU

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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