An observational study in Budd-Chiari Syndrome, sponsored by Institute of Liver and Biliary Sciences, India. Completed at 1 site in India. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-12-27.
Sponsored by Institute of Liver and Biliary Sciences, India · Observational
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.
Primary objective:
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:
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
9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.
This study's enrollment of 33 is below the median of 102 across 2,209 observational studies indexed under Syndrome.
Browse Syndrome studies →Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.
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Patients with Budd -Chiari syndrome who underwent DIPSS revision till February 2021
Exclusion Criteria:
Balloon- Occlusion thrombolysis was done in adjunct to thrombus maceration, balloon sweeping and thrombosuction.
Procedure: Novel
Continuous catheter directed thrombolysis (Continuous urokinase infusion) was done along with thrombus maceration, balloon sweeping and thrombosuction.
Procedure: Conventional
Balloon- Occlusion thrombolysis was done in adjunct to thrombus maceration, balloon sweeping and thrombosuction.
Continuous catheter directed thrombolysis (Continuous urokinase infusion) was done along with thrombus maceration, balloon sweeping and thrombosuction.
Compare the rate of re-stenting between the two groups
Time frame: Day 0
Compare the mean total dose of thrombolytic drug administered between the two groups
Time frame: Day 0
Study DIPSS stent patency and re-occlusion rates at 1 month followup.
Time frame: 1 month
To compare the length of hospital stay between two groups
Time frame: 1 month
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Budd-Chiari Syndrome
Institute of Liver and Biliary Sciences, India