- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04245189
EUS Based Prevalence of Chronic Pancreatitis in Alcoholic Cirrhosis
EUS Based Prevalence of Chronic Pancreatitis in Alcoholic Cirrhosis: Any Difference Between Alcoholic and Non-alcoholic Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mithun Sharma, MD
- Phone Number: 08790622655
- Email: drmithunsharma@gmail.com
Study Locations
-
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Telangana
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Hyderabad, Telangana, India, 500089
- Recruiting
- Asian Institute of Gastroenterology Hospitals
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Sub-Investigator:
- Sundeep Lakhtakia, MD DM
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of chronic pancreatitis in alcoholic cirrhotics as per Rosemont criteria .
Time Frame: 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.
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Pain.
Time Frame: 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.
|
3 days
|
Pancreatic duct size.
Time Frame: 3 days
|
In patients found to have Chronic pancreatitis -Pancreatic duct size would be assessed.
|
3 days
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Stevens T, Parsi MA. Endoscopic ultrasound for the diagnosis of chronic pancreatitis. World J Gastroenterol. 2010 Jun 21;16(23):2841-50. doi: 10.3748/wjg.v16.i23.2841.
- Catalano MF, Sahai A, Levy M, Romagnuolo J, Wiersema M, Brugge W, Freeman M, Yamao K, Canto M, Hernandez LV. EUS-based criteria for the diagnosis of chronic pancreatitis: the Rosemont classification. Gastrointest Endosc. 2009 Jun;69(7):1251-61. doi: 10.1016/j.gie.2008.07.043. Epub 2009 Feb 24.
- Aparisi L, Sabater L, Del-Olmo J, Sastre J, Serra MA, Campello R, Bautista D, Wassel A, Rodrigo JM. Does an association exist between chronic pancreatitis and liver cirrhosis in alcoholic subjects? World J Gastroenterol. 2008 Oct 28;14(40):6171-9. doi: 10.3748/wjg.14.6171.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Digestive System Diseases
- Pathologic Processes
- Alcohol-Related Disorders
- Substance-Related Disorders
- Liver Diseases
- Pancreatic Diseases
- Liver Diseases, Alcoholic
- Alcohol-Induced Disorders
- Fibrosis
- Liver Cirrhosis
- Pancreatitis
- Pancreatitis, Chronic
- Liver Cirrhosis, Alcoholic
Other Study ID Numbers
- AIG-G-EUSCP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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