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

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.

Study Overview

• Status: Completed
• Conditions: Budd-Chiari Syndrome
• Intervention / Treatment: Procedure: Novel; Procedure: Conventional

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver & Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Budd -Chiari syndrome who underwent DIPSS revision till February 2021

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compare the rate of re-stenting between the two groups	Day 0
Compare the mean total dose of thrombolytic drug administered between the two groups	Day 0

Secondary Outcome Measures

Outcome Measure	Time Frame
Study DIPSS stent patency and re-occlusion rates at 1 month followup.	1 month
To compare the length of hospital stay between two groups	1 month

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2021
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: October 30, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): December 27, 2021
• Last Update Submitted That Met QC Criteria: December 23, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Liver Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Syndrome; Budd-Chiari Syndrome
• Other Study ID Numbers: ILBS-Budd-Chiari-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No