NCT05117684

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Budd-Chiari Syndrome

Interventions

Type	Name	Description
PROCEDURE	Novel	Balloon- Occlusion thrombolysis was done in adjunct to 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.

Timeline

• Start date: 2021-11-05
• Primary completion: 2021-12-20
• Completion: 2021-12-20
• First posted: 2021-11-11
• Last updated: 2021-12-27

Locations

1 site across 1 country: India