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A study to evaluate the role of acid suppression medication in reducing post banding ulcers and re bleeding after ligation of bleeding oesophageal varices (dilated blood vessels) in patients with liver cirrhosis

A randomized controlled trial to study the effect of PPI vs No-PPI after EVL on recurrent bleeding episodes in patients of liver cirrhosis with acute variceal bleeding - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054442
Enrollment
170
Registered
2023-06-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: K740- Hepatic fibrosis

Interventions

Intervention1: Proton pump inhibitor (PPI) after achieving hemostasis by EVL of bleeding esophageal varices: After achieving hemostasis by EVL for bleeding esophageal varices, patients in PPI group wo

Sponsors

Post Graduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed cases of liver cirrhosis presenting with decompensation in the form of first episode of variceal bleed

Exclusion criteria

Exclusion criteria: 1-Refractory bleed requiring TIPSS or emergency surgery apart from EVL 2-Upper GI bleed due to acid peptic disease/GERD 3-Hepatocellular carcinoma 4-upper GI Bleed due to malignant tutors go the GI tract 5-Hemodynamic instability requiring vasopressor support 6-Hepatic encephalopathy grade III or above 7-History of surgery of oesophagus, stomach or liver 8- Renal failure with creatinine >2mg/dl 9-Presence of gastric varices as source of upper GI bleed 10-Pregnancy/breastfeeding 11-PPI allergy 12-Mising informed consent

Design outcomes

Primary

MeasureTime frame
To compare the rate of recurrent bleeding between PPI versus no PPI groups after EVL in liver cirrhosis patients with acute varicella bleedTimepoint: From baseline till 12 weeks

Secondary

MeasureTime frame
1-Compare mortality between the 2 groups 2-Compare the size & number of post EVL ulcers at 2 weeks after first EVL session 3- Compare chest pain between 2 group at 2 week and 12 weeks 4-Compare rate of dysphagia between the 2 groupsTimepoint: At 3 months

Countries

India

Contacts

Public ContactHarshal Mandavdhare

Post Graduate Institute of Medical Education and Research

hmandavdhare760@gmail.com9592814877

Outcome results

None listed

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