Genetic Polymorphisms Associated With the Risk of Pancreatitis in Patients With Alcohol Related Cirrhosis.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients > 18 years of age.

Alcohol-related cirrhosis

Males

Disqualifiers

Current Hepatic encephalopathy or cognitive dysfunction precluding adequate nutritional and functional assessment.

HCC.

Complete or partial PVT.

Significant cardio-pulmonary comorbidity

Trial population

* Patients \> 18 years of age. * Who have either alcohol related or non alcohol related cirrhosis.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 2 trial groups
Group A: Alcohol-related cirrhosis
Group B: Liver cirrhosis of other etiologies

Trial outcomes

Primary outcomes

1

Genetic polymorphisms in one or more pancreatitis-associated genes* among patients with alcohol-related cirrhosis, with and without pancreatitis.

Time frame
Day 0

Secondary outcomes

1

Differences in genetic polymorphisms in one or more pancreatitis related genes in patients with pancreatitis between alcohol related cirrhosis and cirrhosis of other etiologies.

Time frame
Day 0
2

To define the relationship of genetic polymorphisms with the pancreatic phenotype.*

Time frame
Day 0
3

Prevalence of pancreatitis defined by CT/MR/EUS among patients with alcohol-related cirrhosis.

Time frame
Day 0
4

Difference in prevalence of pancreatitis defined by CT/MR/EUS among patients with alcohol-related cirrhosis and cirrhosis of other etiologies .

Time frame
Day 0

Other outcomes

Sponsors and contacts

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