Brief Summary

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.

Trial Health

Monitor

Trial Health Score

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

Enrollment

150

participants targeted

Target at P75+ for not_applicable

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

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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 15, 2015

Completed

6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2015

Completed

5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed

Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

10.2 years

First QC Date

July 15, 2015

Last Update Submit

July 20, 2015

Conditions

Portal Vein, Cavernous Transformation Of Hypertension, Portal

Keywords

Portal Vein, Cavernous Transformation OfHypertension, PortalRadiology, InterventionalPortalsystemic shunt

Outcome Measures

Primary Outcomes (2)

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

Study Arms (1)

Transhepatic portosystemic shunt

EXPERIMENTAL

Patients with cavernous transformation of portal vein undergo transhepatic portalsystemic shunt and other interventional radiology treatment

Procedure: Transhepatic portosystemic shuntDevice: 6-French sheathDevice: 22-gauge chiba needleDevice: 260-cm-long stiff shaft wireDevice: Balloon catheterDevice: Bare metal stentDevice: Covered stent

Interventions

Transhepatic portosystemic shuntPROCEDURE

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.