EUS Based Prevalence of Chronic Pancreatitis in Alcoholic Cirrhosis

• Conditions: Alcoholic Cirrhosis

• Registration Number: NCT04245189
• Lead Sponsor: Asian Institute of Gastroenterology, India

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.

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 Timeline

• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-28
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-24
• Last Update Posted: 2021-01-26
• Study Start: 2021-02-01
• Primary Completion: 2021-10-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Pancreatic duct size.	3 days	In patients found to have Chronic pancreatitis -Pancreatic duct size would be assessed.

Trial Locations

Locations (1)

Asian Institute of Gastroenterology Hospitals; 🇮🇳 Hyderabad, Telangana, India