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A comparison between one time radiological intervention to one step at a time of medical therapy followed by radiological intervention in patients with Budd Chiari syndrome

Stepwise protocol vs first step radiological intervention in patients with Budd Chiari syndrome: A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046661
Enrollment
30
Registered
2022-10-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K77- Liver disorders in diseases classified elsewhere

Interventions

Intervention1: First step intervention: Radiological intervention (Hepatic Vein,Inferior Vena cava Angioplasty, Transjugular intrahepatic portosystemic shunt) ,Anticoagulation Diuretics Control Interv

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Homogenous Budd Chari cohort with ascites and a block of the hepatic vein with or without inferior vena cava (IVC). 2. Treatment naïve BCS patient willing to undergo therapeutic intervention for BCS 3. Those patients undergoing HV stenting or TIPS 4. Willing to participate in the study

Exclusion criteria

Exclusion criteria: 1. Patients with isolated IVC blocks 2. Previous intervention for BCS 3. Clinical presentation as acute liver failure and acute-on-chronic liver failure 4. Underlying associated severe cardiac and pulmonary diseases 5. Patients with malignancy/disseminated intravascular coagulation (DIC)/known coagulopathy disorder 6. History of intake of platelets inhibitors (eg, aspirin, clopidogrel) and drugs affecting coagulation cascade (eg, vitamin K antagonists) for any indication 7. Pregnant women and those on oral contraceptives 8. Patients with chronic renal failure 9. Patients with shock 10. Sepsis 11. History of contrast allergy 12. Not willing to provide consent

Design outcomes

Primary

MeasureTime frame
The difference in the complete response rate (defined as disappearance of ascites on ultrasound and no requirement of diuretics) between the first step intervention and stepwise intervention group at the end of 3 months.Timepoint: 3 months.—

Secondary

MeasureTime frame
Secondary objective: 1. Change in liver function tests over 3 months 2. Change in grades of varices & ascites over 3 months 2. Change in CTP score, HVOTO-AIIMS score, Rotterdam BCS index & BCS-TIPS PI over 3 months. 3. Complications related to intervention & conservative therapy over 3 months of therapy. 4. Change in liver stiffness measurement (LSM) over 3 months.Timepoint: 3 months—

Countries

India

Contacts

Public ContactDr Shalimar

All India Institute of Medical Sciences

drshalimar@gmail.com9868397211

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026