Percutaneous Transhepatic Intrahepatic Portosystemic Shunt for Treatment of Portal Vein Occlusion With Symptomatic Portal Hypertension After Splenectomy
1 other identifier
interventional
50
1 country
1
Brief Summary
To evaluate the values of percutaneous transhepatic intrahepatic portosystemic shunt for treatment of portal vein occlusion with symptomatic portal hypertension after splenectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
July 16, 2015
CompletedFirst Posted
Study publicly available on registry
July 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedNovember 11, 2015
November 1, 2015
6.2 years
July 16, 2015
November 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
No gastrointestinal rebleeding in 1 month after interventions
No gastrointestinal rebleeding in 1 month after interventions
1 month
Ascites disappear in 1 month after interventions
Ascites disappear in 1 month after interventions
1 month
Secondary Outcomes (1)
Whether the shunt is patent after interventions in 6 months
6 months
Study Arms (1)
Shunt
EXPERIMENTALPerform percutaneous transhepatic intrahepatic portosystemic shunt
Interventions
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.
Eligibility Criteria
You may qualify if:
- All patients with portal hypertension who have the history of splenectomy and have enough image information to confirm occlusion of portal vein
You may not qualify if:
- Patients with known severe dysfunction of heart, lung, brain, kidney and other vital organs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Radiology
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zaibo Jiang, MD.
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Radiology, The Third Affiliated Hospital, Sun Yat-Sen University
Study Record Dates
First Submitted
July 16, 2015
First Posted
July 22, 2015
Study Start
October 1, 2010
Primary Completion
December 1, 2016
Last Updated
November 11, 2015
Record last verified: 2015-11