To Compare "Balloon Occluded Thrombolysis" With "Conventional Catheter Directed Thrombolysis" in Thrombotically Occluded DIPSS Stent in Patients of Budd- Chiari Syndrome.

Budd-Chiari Syndrome Clinical Trial

Official title:

To Compare "Balloon Occluded Thrombolysis" With "Conventional Catheter Directed Thrombolysis" in Thrombotically Occluded DIPSS Stent in Patients of Budd- Chiari Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05117684
• Other study ID #: ILBS-Budd-Chiari-01
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Budd-Chiari Syndrome
• Syndrome

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