NCT06763198

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

January 25, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

January 22, 2025

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

January 1, 2025

Last Update Submit

January 20, 2025

Conditions

Alcohol-related Liver Disease

Outcome Measures

Primary Outcomes (1)

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

    Day 0

Secondary Outcomes (8)

  • 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.*

    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

  • +3 more secondary outcomes

Study Arms (2)

Alcohol-related cirrhosis

Alcohol-related cirrhosis

Liver cirrhosis of other etiologies

Liver cirrhosis of other etiologies

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMales
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients \> 18 years of age.
  • Alcohol-related cirrhosis
  • Males

You may not qualify if:

  • Current Hepatic encephalopathy or cognitive dysfunction precluding adequate nutritional and functional assessment.
  • HCC.
  • Complete or partial PVT.
  • Significant cardio-pulmonary comorbidity
  • Patients who do not consent for genetic study
  • Inability to provide informed consent.
  • Cannot understand Hindi or English should be excluded since they will not be able to reply objectively to questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Central Study Contacts

Dr Aakula Suguna Sree, MD

CONTACT

01146300000sugunasreeaakula@gmail.com

Prof. Vikram Bhatia, DM

CONTACT

01146300000vikrambhatiadr@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2025

First Posted

January 8, 2025

Study Start

January 25, 2025

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

January 22, 2025

Record last verified: 2024-12

Locations

IN(1)