Back to resultsInterventional Radiology for the Treatment of Symptomatic Portal Hypertension in Patients With Cavernous Transformation of Portal Vein
Primary Purpose
Portal Vein, Cavernous Transformation Of, Hypertension, Portal
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transhepatic portosystemic shunt
6-French sheath
22-gauge chiba needle
260-cm-long stiff shaft wire
Balloon catheter
Bare metal stent
Covered stent
Sponsored by
About this trial
This is an interventional treatment trial for Portal Vein, Cavernous Transformation Of focused on measuring Portal Vein, Cavernous Transformation Of, Hypertension, Portal, Radiology, Interventional, Portalsystemic shunt
Eligibility Criteria
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.
Sites / Locations
- Department of RadiologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transhepatic portosystemic shunt
Arm Description
Patients with cavernous transformation of portal vein undergo transhepatic portalsystemic shunt and other interventional radiology treatment
Outcomes
Primary Outcome Measures
Incidence Rate of Gastrointestinal Bleeding
No gastrointestinal bleeding proved by patients' symptoms (If the patients had the history of gastrointestinal bleeding before)
Ascites Volume (mL)
No ascites proved by CT scanning or ultrasound (If the patients had the history of ascites before)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02504034
Brief Title
Interventional Radiology for the Treatment of Symptomatic Portal Hypertension in Patients With Cavernous Transformation of Portal Vein
Official Title
Interventional Radiology for the Treatment of Symptomatic Portal Hypertension in Patients With Cavernous Transformation of Portal Vein
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2020 (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 portosystemic shunt and other interventional radiology approaches for treatment of symptomatic portal hypertension in patients with cavernous transformation of portal vein.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Vein, Cavernous Transformation Of, Hypertension, Portal
Keywords
Portal Vein, Cavernous Transformation Of, Hypertension, Portal, Radiology, Interventional, Portalsystemic shunt
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transhepatic portosystemic shunt
Arm Type
Experimental
Arm Description
Patients with cavernous transformation of portal vein undergo transhepatic portalsystemic shunt and other interventional radiology treatment
Intervention Type
Procedure
Intervention Name(s)
Transhepatic portosystemic shunt
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
6-French sheath
Intervention Type
Device
Intervention Name(s)
22-gauge chiba needle
Intervention Type
Device
Intervention Name(s)
260-cm-long stiff shaft wire
Intervention Type
Device
Intervention Name(s)
Balloon catheter
Intervention Type
Device
Intervention Name(s)
Bare metal stent
Intervention Type
Device
Intervention Name(s)
Covered stent
Primary Outcome Measure Information:
Title
Incidence Rate of Gastrointestinal Bleeding
Description
No gastrointestinal bleeding proved by patients' symptoms (If the patients had the history of gastrointestinal bleeding before)
Time Frame
1 month
Title
Ascites Volume (mL)
Description
No ascites proved by CT scanning or ultrasound (If the patients had the history of ascites before)
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zaibo Jiang, MD.
Phone
+86 020 85252066
Email
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
Email
jiangzaibo@aliyun.com
12. IPD Sharing Statement
Learn more about this trial
Interventional Radiology for the Treatment of Symptomatic Portal Hypertension in Patients With Cavernous Transformation of Portal Vein
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