A Novel Approach for Transjugular Intrahepatic Portocaval Shunt Creation Using Real-time Three Dimensional Roadmap
1 other identifier
interventional
30
1 country
1
Brief Summary
TIPS creation has been widely used to treat the complications associated with portal hypertension. In association with increased operator experience and the ongoing development of imaging modalities, the rate of major complications associated with TIPS has decreased significantly in the past decades. However, the passage of a curved needle from the hepatic vein into the portal vein still remains a challenging and time-consuming part of the procedure and is associated with puncture-related complications that are potentially fatal.Three-dimensional roadmap guidance has been widely applied in various interventions. The aim of the present study is to prospectively assess the feasibility and efficacy of real-time 3D roadmap guidance during TIPS creation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2017
Shorter than P25 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
First Submitted
Initial submission to the registry
January 21, 2017
CompletedFirst Posted
Study publicly available on registry
January 25, 2017
CompletedStudy Start
First participant enrolled
February 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2017
CompletedJanuary 8, 2019
January 1, 2019
4 months
January 21, 2017
January 7, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Technical success rate
number of patients who have received TIPS creation technically successfully
1 month
number of punctures
number of intrahepatic punctures for TIPS creation
1 month
Secondary Outcomes (3)
radiographic fluoroscopy time for portal vein entry
1 month
radiographic fluoroscopy time for the whole procedure
1 month
procedural time
1 month
Study Arms (2)
3D roadmap
EXPERIMENTALTIPS was established using 3d roadmap guidance
conventional TIPS
ACTIVE COMPARATORconventional TIPS procedure using wedged hepatic venography
Interventions
conventional TIPS procedure using wedged hepatic venography
Eligibility Criteria
You may qualify if:
- cirrhosis complications of portal hypertension requiring TIPS
You may not qualify if:
- non-cirrhotic portal hypertension complete occlusion of intrahepatic portal vein gastro-renal shunt presence of liver tumor pregnancy other contradictions of TIPS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West China Hospital
Chengdu, Sichuan, 610041, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- attending doctor
Study Record Dates
First Submitted
January 21, 2017
First Posted
January 25, 2017
Study Start
February 13, 2017
Primary Completion
May 30, 2017
Study Completion
May 30, 2017
Last Updated
January 8, 2019
Record last verified: 2019-01