Percutaneous Transhepatic Intrahepatic Portosystemic Shunt for Treatment of Portal Vein Occlusion With Symptomatic Portal Hypertension After Splenectomy
Sponsor
Sun Yat-sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02505152
Collaborator
(none)
50
1
1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date
:
Oct 1, 2010
Anticipated Primary Completion Date
:
Dec 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Shunt Perform percutaneous transhepatic intrahepatic portosystemic shunt |
Procedure: Percutaneous transhepatic intrahepatic portosystemic shunt
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.
|
Outcome Measures
Primary Outcome Measures
- No gastrointestinal rebleeding in 1 month after interventions [1 month]
No gastrointestinal rebleeding in 1 month after interventions
- Ascites disappear in 1 month after interventions [1 month]
Ascites disappear in 1 month after interventions
Secondary Outcome Measures
- Whether the shunt is patent after interventions in 6 months [6 months]
Patent shunt in 6 months after interventions proved by US or CT
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Radiology | Guangzhou | Guangdong | China | 510000 |
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:
NCT02505152
Other Study ID Numbers:
- PTIPSDORNO3HSYSU
First Posted:
Jul 22, 2015
Last Update Posted:
Nov 11, 2015
Last Verified:
Nov 1, 2015
Keywords provided by Zaibo Jiang,
Department of Radiology, The Third Affiliated Hospital, Sun Yat-Sen University,
Sun Yat-sen University
Additional relevant MeSH terms: