NCT04245189

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.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

8 months

First QC Date

January 21, 2020

Last Update Submit

January 24, 2021

Conditions

Alcoholic Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Assessment of Pain.

    3 days

  • Pancreatic duct size.

    3 days

Interventions

Endoscopic ultrasound for detection of Chronic pancreatitisOTHER

Presence of Chronic pancreatitis in alcoholic cirrhosis patients.

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients attending the Hepatology unit of AIG Hospitals.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian Institute of Gastroenterology Hospitals

Hyderabad, Telangana, 500089, India

RECRUITING

Related Publications (3)

  • 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.

    PMID: 20556829BACKGROUND

  • 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.

    PMID: 19243769BACKGROUND

  • 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.

    PMID: 18985807BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis, Alcoholic

Condition Hierarchy (Ancestors)

Liver CirrhosisLiver DiseasesDigestive System DiseasesLiver Diseases, AlcoholicFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Mithun Sharma

    AIG Hospitals

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mithun Sharma, MD

CONTACT

08790622655drmithunsharma@gmail.com

Study Design

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

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 28, 2020

Study Start

February 1, 2021

Primary Completion

October 1, 2021

Study Completion

December 31, 2021

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations

IN(1)