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

NCT05117684 | Completed

• 1 other identifier: ILBS-Budd-Chiari-01
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Budd-Chiari Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

Novel

Balloon- Occlusion thrombolysis was done in adjunct to thrombus maceration, balloon sweeping and thrombosuction.

Procedure: Novel

Conventional

Continuous catheter directed thrombolysis (Continuous urokinase infusion) was done along with thrombus maceration, balloon sweeping and thrombosuction.

Procedure: Conventional

Interventions

Novel PROCEDURE

Balloon- Occlusion thrombolysis was done in adjunct to thrombus maceration, balloon sweeping and thrombosuction.

Novel

Conventional PROCEDURE

Continuous catheter directed thrombolysis (Continuous urokinase infusion) was done along with thrombus maceration, balloon sweeping and thrombosuction.

Conventional

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients of Budd- Chiari syndrome who underwent DIPSS revision for blocked stent till February 2021

You may not qualify if:

• Patients who underwent DIPSS revision more than one time using both the techniques were excluded.
• Failure to cannulate existing shunt.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Budd-Chiari Syndrome

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2021
• First Posted: November 11, 2021
• Study Start: November 5, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: December 27, 2021

Record last verified: 2021-12

Locations

IN (1)