Status:
UNKNOWN
Spleen Stiffness as a Measure to Assess the REsponse to β Blocker Therapy (SPARE-B)
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
High Risk Esophageal Varices
Eligibility:
All Genders
18-70 years
Brief Summary
HVPG is the gold standard for measurement of the presence and severity of portal hypertension. Clinically Significant Portal Hypertension (CSPH) is defined as HVPG ≥ 10 mmHg. Reducing the HVPG by use ...
Detailed Description
Aim and Objective: To evaluate change in splenic stiffness measurement as a surrogate for response to non-selective beta blockers in patients with high-risk esophageal varices. Primary objectives: To...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Cirrhosis of liver of different etiologies, with evidence of high-risk esophageal varices
- Alcohol abstinence for 3 months
- Written informed consent
Exclusion
- Age ≥ 70 years
- Previous or imminent variceal ligation
- Non Cirrhotic Portal Hypertension
- Portal vein, splenic vein thrombosis
- Porto-systemic shunts \> 10 mm
- Patients already on beta blockers
- Contraindications to beta blocker therapy :
- Heart rate \< 50 bpm
- Systolic BP \< 100 mm Hg
- Severe COPD
- Atrioventricular block
- Known PVD
- Poor control of T2DM (HbA1c\>9)
- Technical difficulties for splenic stiffness measurement
- Cardio-pulmonary disorders
- Budd Chiari Syndrome
- Grade 3 ascites
- Acute Kidney Injury or Chronic Kidney Disease
- Severely Obese patients (BMI \> 40)
- Pregnant women
- Advanced HCC
- Psychiatric Illness
- Lack of informed consent
Key Trial Info
Start Date :
September 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06050837
Start Date
September 30 2023
End Date
August 31 2024
Last Update
September 22 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070