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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05117684
Other study ID # ILBS-Budd-Chiari-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 5, 2021
Est. completion date December 20, 2021

Study information

Verified date December 2021
Source Institute of Liver and Biliary Sciences, India
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

DIPSS has become a widely accepted treatment for complications of portal hypertension. Shunt or hepatic vein stenosis are common short and mid term complications of the procedure. When identified early, shunt stenosis or occlusion may be treated before recurrence of the symptoms for which DIPSS was done at the first place. Present day endovascular DIPSS revision techniques have significantly improved the primary assisted patency rates. The purpose of this study is to understand the newer technique of Combined balloon occlusion thrombolysis and intra stent balloon sweeping being practiced at our institute and compare it with the widely used conventional thrombolytic methods.


Description:

Primary objective: 1. To study the outcome of combined technique of Balloon occluded thrombolysis, Balloon sweeping and maceration of thrombus in Blocked DIPSS stent and compare it with Conventional catheter directed thrombolysis and angioplasty. Secondary objective: 2. Study DIPSS stent patency and re-occlusion rates at 1 month followup Methodology: Study population: Patients with Budd -Chiari syndrome who underwent DIPSS revision till February 2021 Study design: Single center retrospective cohort study Study period: 1year Sample size: All eligible patients according to inclusion and exclusion criteria who underwent TIPS/DIPS revision will be included in thestudy. Intervention: DIPSS Revision Monitoring andassessment: The following parameters to be evaluated over a period at least 1 month after DIPSS revision and compare with pre revisionvalues Clinical parameters: Status of ascites Urine output Recurrence of UGI/LGI bleed Laboratory parameters: ALBI Score,LFT, KFT DOPPLER PARAMETERS: Mid stent velocity, velocity at hepatic venous end Main portal vein velocity Direction of flow in intrahepatic portal vein branches Stopping rule: Not applicable. Expected outcome of the project: Balloon Occluded thrombolytic infusion alongwith intratsent balloon sweeping gives faster and better patency as compared to conventional pharmaco-mechanicalthrombolytic methods


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date December 20, 2021
Est. primary completion date December 20, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Patients of Budd- Chiari syndrome who underwent DIPSS revision for blocked stent till February 2021 Exclusion Criteria: 1. Patients who underwent DIPSS revision more than one time using both the techniques were excluded. 2. Failure to cannulate existing shunt.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Novel
Balloon- Occlusion thrombolysis was done in adjunct to thrombus maceration, balloon sweeping and thrombosuction.
Conventional
Continuous catheter directed thrombolysis (Continuous urokinase infusion) was done along with thrombus maceration, balloon sweeping and thrombosuction.

Locations

Country Name City State
India Institute of Liver & Biliary Sciences New Delhi Delhi

Sponsors (1)

Lead Sponsor Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compare the rate of re-stenting between the two groups Day 0
Primary Compare the mean total dose of thrombolytic drug administered between the two groups Day 0
Secondary Study DIPSS stent patency and re-occlusion rates at 1 month followup. 1 month
Secondary To compare the length of hospital stay between two groups 1 month
See also
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