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Alcohol is a known risk factor for both pancreatitis and cirrhosis. However, not all patients with alcohol related cirrhosis develop pancreatitis. It is not known which patients with alcohol-related cirrhosis develop symptomatic or clinically inapparent pancreatitis (Acute or Chronic Pancreatitis).There is no data whether genetic polymorphisms predispose patients with alcohol-related cirrhosis to additional pancreatic injury. There is no data on the spectrum of clinical and subclinical pancreatic changes (structural and functional) in patients with alcohol-related cirrhosis, and their genotypic correlates.This study aims to determine pancreatitis-related gene variants among patients with alcohol-related cirrhosis, with and without pancreatitis. We also aim to study differences in nutritional and functional parameters among alcoholic cirrhosis with and without chronic pancreatitis and also define the relationship of genetic polymorphisms with the pancreatic phenotype. Consecutive patients with alcohol related cirrhosis will be screened for changes of pancreatitis on CT/MR/EUS. Those with and without pancreatitis will be compared with respect to demographic, clinical, genotype, nutritional status .We will also be including a group of MAFLD/Cryptogenic cirrhosis for genotypic and phenotypic comparison.
Aim and Objective - To determine pancreatitis-related gene variants among patients with alcohol-related cirrhosis, with and without pancreatitis.
Primary objective: To determine the genetic variants associated with morphological and functional pancreatic changes among patients with alcohol-related cirrhosis.
Secondary objectives
Hypothesis -
- Genetic polymorphisms related to pancreatitis predispose patients with alcohol-related cirrhosis to additional pancreatic injury.
Associated chronic pancreatitis (clinically apparent or subclinical) negatively influences the nutritional and functional status of patients with alcohol-related cirrhosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol-related cirrhosis | Alcohol-related cirrhosis | ||
| Liver cirrhosis of other etiologies | Liver cirrhosis of other etiologies |
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| Measure | Description | Time Frame |
|---|---|---|
| Genetic polymorphisms in one or more pancreatitis-associated genes* among patients with alcohol-related cirrhosis, with and without pancreatitis. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in genetic polymorphisms in one or more pancreatitis related genes in patients with pancreatitis between alcohol related cirrhosis and cirrhosis of other etiologies. | Day 0 | |
| To define the relationship of genetic polymorphisms with the pancreatic phenotype.* |
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Inclusion Criteria:
Exclusion Criteria:
Males
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Aakula Suguna Sree, MD | Contact | 01146300000 | sugunasreeaakula@gmail.com | |
| Prof. Vikram Bhatia, DM | Contact | 01146300000 | vikrambhatiadr@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences (ILBS) | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| Day 0 |
| Prevalence of pancreatitis defined by CT/MR/EUS among patients with alcohol-related cirrhosis. | Day 0 |
| Difference in prevalence of pancreatitis defined by CT/MR/EUS among patients with alcohol-related cirrhosis and cirrhosis of other etiologies . | Day 0 |
| Severe exocrine insufficiency defined by fecal elastase <100µg/g stool among cirrhotic patients with and without chronic pancreatitis | Day 0 |
| Endocrine insufficiency defined by FBS >126mg/dl and HbA1c >6.5% among cirrhotic patients with and without chronic pancreatitis. | Day 0 |
| Sarcopenia defined by Skeletal muscle index of < 50cm/m2 in men on CT, and/or 7.0 kg/m2 on DEXA among cirrhotic patients with and without chronic pancreatitis. | Day 0 |
| Liver frailty index > 4.5 | Day 0 |