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A Novel Approach for Transjugular Intrahepatic Portocaval Shunt Creation Using Real-time Three Dimensional Roadmap

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031366
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
luo xuefeng, West China Hospital

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.

Condition or disease Intervention/treatment Phase
Portal Hypertension Other: 3d roadmap guidance Other: conventional TIPS procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: TIPS creation using real-time 3D roadmap
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Novel Approach for Transjugular Intrahepatic Portocaval Shunt Creation Using Real-time Three Dimensional Roadmap
Actual Study Start Date : February 13, 2017
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : May 30, 2017

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Arm Intervention/treatment
Experimental: 3D roadmap
TIPS was established using 3d roadmap guidance
Other: 3d roadmap guidance
TIPS was established using 3d roadmap

Active Comparator: conventional TIPS
conventional TIPS procedure using wedged hepatic venography
Other: conventional TIPS procedure
conventional TIPS procedure using wedged hepatic venography




Primary Outcome Measures :
  1. Technical success rate [ Time Frame: 1 month ]
    number of patients who have received TIPS creation technically successfully

  2. number of punctures [ Time Frame: 1 month ]
    number of intrahepatic punctures for TIPS creation


Secondary Outcome Measures :
  1. radiographic fluoroscopy time for portal vein entry [ Time Frame: 1 month ]
    duration of radiographic fluoroscopy for portal vein entry

  2. radiographic fluoroscopy time for the whole procedure [ Time Frame: 1 month ]
    duration of radiographic fluoroscopy for the whole procedure

  3. procedural time [ Time Frame: 1 month ]
    procedural time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

cirrhosis complications of portal hypertension requiring TIPS

Exclusion Criteria:

non-cirrhotic portal hypertension complete occlusion of intrahepatic portal vein gastro-renal shunt presence of liver tumor pregnancy other contradictions of TIPS


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031366


Locations
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China, Sichuan
West China Hospital
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Hospital
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Responsible Party: luo xuefeng, attending doctor, West China Hospital
ClinicalTrials.gov Identifier: NCT03031366    
Other Study ID Numbers: 3D roadmap for TIPS
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Portal
Liver Diseases
Digestive System Diseases