EUS Based Prevalence of Chronic Pancreatitis in Alcoholic Cirrhosis

Alcoholic Cirrhosis Clinical Trial

Official title:

EUS Based Prevalence of Chronic Pancreatitis in Alcoholic Cirrhosis: Any Difference Between Alcoholic and Non-alcoholic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04245189
• Other study ID #: AIG-G-EUSCP
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2021
• Source: Asian Institute of Gastroenterology, India
• Contact: Mithun Sharma, MD
• Phone: 08790622655
• Email: drmithunsharma[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: October 1, 2021
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholic Cirrhosis
• Fibrosis
• Liver Cirrhosis
• Liver Cirrhosis, Alcoholic
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Other:
• Endoscopic ultrasound for detection of Chronic pancreatitis
Presence of Chronic pancreatitis in alcoholic cirrhosis patients.

Locations

Country	Name	City	State
India	Asian Institute of Gastroenterology Hospitals	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

References & Publications (3)

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. — View Citation

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. — View Citation

Stevens T, Parsi MA. Endoscopic ultrasound for the diagnosis of chronic pancreatitis. World J Gastroenterol. 2010 Jun 21;16(23):2841-50. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of chronic pancreatitis in alcoholic cirrhotics as per Rosemont criteria .	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	Assessment of Pain.	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
Secondary	Pancreatic duct size.	In patients found to have Chronic pancreatitis -Pancreatic duct size would be assessed.	3 days