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Percutaneous Transhepatic Intrahepatic Portosystemic Shunt for Treatment of Portal Vein Occlusion With Symptomatic Portal Hypertension After Splenectomy

Primary Purpose

Hypertension, Portal, Portal Vein, Cavernous Transformation Of

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Percutaneous transhepatic intrahepatic portosystemic shunt

About this trial

This is an interventional treatment trial for Hypertension, Portal focused on measuring Hypertension, Portal, Portal Vein, Cavernous Transformation Of, Portosystemic shunt, Radiology, Interventional

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All patients with portal hypertension who have the history of splenectomy and have enough image information to confirm occlusion of portal vein

Exclusion Criteria:

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

Sites / Locations

Department of RadiologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Shunt

Arm Description

Perform percutaneous transhepatic intrahepatic portosystemic shunt

Outcomes

Primary Outcome Measures

No gastrointestinal rebleeding in 1 month after interventions

Ascites disappear in 1 month after interventions

Secondary Outcome Measures

Whether the shunt is patent after interventions in 6 months

Patent shunt in 6 months after interventions proved by US or CT

Full Information

NCT ID

NCT02505152

First Posted

July 16, 2015

Last Updated

November 10, 2015

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02505152

Brief Title

Percutaneous Transhepatic Intrahepatic Portosystemic Shunt for Treatment of Portal Vein Occlusion With Symptomatic Portal Hypertension After Splenectomy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

October 2010 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

5. Study Description

Brief Summary

To evaluate the values of percutaneous transhepatic intrahepatic portosystemic shunt for treatment of portal vein occlusion with symptomatic portal hypertension after splenectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Portal, Portal Vein, Cavernous Transformation Of

Keywords

Hypertension, Portal, Portal Vein, Cavernous Transformation Of, Portosystemic shunt, Radiology, Interventional

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Shunt

Arm Type

Experimental

Arm Description

Perform percutaneous transhepatic intrahepatic portosystemic shunt

Intervention Type

Procedure

Intervention Name(s)

Percutaneous transhepatic intrahepatic portosystemic shunt

Intervention Description

Under fluoroscopic guidance, 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 7-French sheath inserted over the wire. Then retrohepatic inferior vena cava(RIVC) or hepatic vein(HV) was punctured with a 20-gauge, 30-cm Chiba needle through 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 stiff shaft wire was then introduced through the transjugular sheath and manipulated into main portal vein(MPV) and then into superior mesenteric vein(SMV). Afterward the PTIPS procedure was completed in the standard transjugular fashion.

Primary Outcome Measure Information:

Title

No gastrointestinal rebleeding in 1 month after interventions

Description

No gastrointestinal rebleeding in 1 month after interventions

Time Frame

1 month

Title

Ascites disappear in 1 month after interventions

Description

Ascites disappear in 1 month after interventions

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Whether the shunt is patent after interventions in 6 months

Description

Patent shunt in 6 months after interventions proved by US or CT

Time Frame

6 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients with portal hypertension who have the history of splenectomy and have enough image information to confirm occlusion of portal vein Exclusion Criteria: Patients with known severe dysfunction of heart, lung, brain, kidney and other vital organs

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zaibo Jiang, MD.

Phone

+86 020 85252066

jiangzaibo@aliyun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zaibo Jiang, MD.

Organizational Affiliation

Sun Yat-sen University

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Radiology

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zaibo Jiang, MD.

Phone

+86 020 85252066

jiangzaibo@aliyun.com

12. IPD Sharing Statement

Learn more about this trial

Percutaneous Transhepatic Intrahepatic Portosystemic Shunt for Treatment of Portal Vein Occlusion With Symptomatic Portal Hypertension After Splenectomy

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