EUS Based Prevalence of Chronic Pancreatitis in Alcoholic Cirrhosis

Sponsor
Asian Institute of Gastroenterology, India (Other)
Overall Status
Recruiting
CT.gov ID
NCT04245189
Collaborator
(none)
100
1
10.9
9.1

Study Details

Study Description

Brief Summary

Alcohol is the common precipitating factor for both cirrhosis of liver as well as alcohol related chronic pancreatitis. However, in real life clinical setting, clinicians do not frequently see many cases of symptomatic pancreatitis in patients who present with features of cirrhosis of liver. On the contrary, in some patients presenting with alcohol related chronic pancreatitis, evidence of cirrhosis of liver is observed on imaging without other clinical features of cirrhosis.

Condition or Disease Intervention/Treatment Phase
  • Other: Endoscopic ultrasound for detection of Chronic pancreatitis

Detailed Description

The data on exact incidence of chronic pancreatitis in patients with alcoholic cirrhosis is scarce and there are no data to support or refute as to whether the incidence is same between alcoholic cirrhosis or cirrhosis due to any other cause. The co-existence of cirrhosis and chronic pancreatitis in alcoholics vary between 0.04 - 6%.

However, till now no study has been conducted to evaluate the incidence of CP in patients with alcoholic cirrhosis of liver. In this study, the investigators propose to assess the incidence of chronic pancreatitis in patients of ethanol related cirrhosis of liver and compare the same with patients of cryptogenic liver cirrhosis and hepatitis B and C related liver cirrhosis. This would be one of the few studies till date, to use EUS as the diagnostic modality.

The patients of cirrhosis would be categorized based on their Child Pugh criteria into three categories. All these patients would undergo EUS at the Institute and chronic pancreatitis screening would be considered positive if they fulfill the Rosemont criteria for chronic pancreatitis.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
EUS Based Prevalence of Chronic Pancreatitis in Alcoholic Cirrhosis: Any Difference Between Alcoholic and Non-alcoholic Patients
Anticipated Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Outcome Measures

Primary Outcome Measures

  1. Incidence of chronic pancreatitis in alcoholic cirrhotics as per Rosemont criteria . [3 days]

    To assess the incidence of chronic pancreatitis in patients of ethanol related cirrhosis of liver and compare the same with patients of cryptogenic liver cirrhosis, hepatitis B and C related liver cirrhosis.

Secondary Outcome Measures

  1. Assessment of Pain. [3 days]

    Visual Analogue Scale (VAS) measures pain intensity based on observer assessment on a scale from 1 to 10, where higher values indicate more intense pain.

  2. Pancreatic duct size. [3 days]

    In patients found to have Chronic pancreatitis -Pancreatic duct size would be assessed.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 65 Years
Sexes Eligible for Study:
All
Inclusion Criteria:

• Patients with diagnosis of ethanol related cirrhosis of liver who complains of central abdominal pain without any other identifiable cause of pain would be enrolled in the study.

Exclusion Criteria:
  • Any patients with evidence of Hepatocellular carcinoma , autoimmune hepatitis related CLD, and PBC would be excluded.

  • Patients any co-existent other malignancy, sepsis, pregnancy.

  • An informed consent would be signed by the patient and any patient not willing to be a part of the study will be excluded.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asian Institute of Gastroenterology Hospitals Hyderabad Telangana India 500089

Sponsors and Collaborators

  • Asian Institute of Gastroenterology, India

Investigators

  • Principal Investigator: Mithun Sharma, AIG Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier:
NCT04245189
Other Study ID Numbers:
  • AIG-G-EUSCP
First Posted:
Jan 28, 2020
Last Update Posted:
Jan 26, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2021