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Prevalence of Exocrine Pancreatic Insufficiency in Patients With Decompensated Cirrhosis ((EPIIHC))

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ClinicalTrials.gov Identifier: NCT03236038
Recruitment Status : Not yet recruiting
First Posted : August 1, 2017
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Jordi Sanchez-Delgado, Corporacion Parc Tauli

Brief Summary:

Exocrine pancreatic insufficiency (EPI) is the inability of the pancreas to perform a normal digestive function. The prevalence of IPE in patients with decompensated hepatic cirrhosis (HC) is unknown and most published series are short, old and use a single diagnostic technique with potential risk of false positives and negatives. Demonstrating IPE in a patient with HC can change their vital prognosis with the indication of pancreatic enzymes that can improve their nutritional status and help control their decompensations.

Objectives: To assess the prevalence of IPE in patients with decompensated CH. To establish correlation between fecal elastase and 13C triolein breath test.

Methodology: Unicentric, transversal study that will be carried out during hospitalization. Patients with HC who enter for decompensation and requiere hospitalization will be included consecutively. Exclusion criteria will include prior diagnosis of IPE, suspicion of biliary obstruction, more than 5 dep / d induced by laxatives or liquid stools.

The diagnosis of IPE will be made with the combination of two techniques (13C triolein breath test and fecal elastase).

Demographic, epidemiological data, clinical data as well as anthropometric parameters will be collected. A blood test will also be done to assess nutritional status and associated deficits. A multivariate analysis will be performed to assess the predictive factors of IPE


Condition or disease Intervention/treatment
Exocrine Pancreatic Insufficiency Diagnostic Test: Labeled triolein urea breath test

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 56 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Prevalence of Exocrine Pancreatic Insufficiency in Patients With Decompensated Cirrhosis
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Labeled triolein urea breath test

    The diagnosis of EPI will be made through the combination of two diagnostic tests.

    The labeled triolein breath test will use criteria established by the manufacturer of the product (Pancreo-Kit®) Isomed pharma.

    The fecal elastase test will be performed at our own center (Bioserv Diagnostics (BS-86-01 Elastase Pancreatic ELISA) distributed by Palex Medical.) In those cases where both results are negative, it will be considered that there is no EPI. In cases where both results are positive, the diagnosis of EPI will be performed. If the results are discordant, a Sobel test or feces quantification test will be performed.

    Other Name: fecal elastase


Primary Outcome Measures :
  1. Prevalence of exocrine pancreatic insufficiency in decompensated alcoholic cirrhosis [ Time Frame: This is a prevalence study. Outcome measure will be assessed during patient admision in the hospital. Data will be reported once the inclusion has been completed (2 years). ]

    The diagnosis of EPI will be made through the combination of two diagnostic tests.

    The labeled triolein breath test will use criteria established by the manufacturer of the product (Pancreo-Kit®) Isomed pharma.

    Reference value: Normal: > 29%; Pathological: < 29% of the fat administered

    The fecal elastase test (Bioserv Diagnostics (BS-86-01 Elastase Pancreatic ELISA) distributed by Palex Medical.)

    • A normal result will be considered: 200 to > 500 μg / g
    • Slight exocrine pancreatic insufficiency- Moderate: 100 - 200 μg / g
    • Severe exocrine pancreatic insufficiency: <100 μg / g

    In those cases where both results are negative, it will be considered that there is no EPI. In cases where both results are positive, the diagnosis of EPI will be performed. If the results are discordant, a Sobel test or feces quantification test will be performed.

    Coefficient of fat absorption; Pathological if elimination > 7g of fat / day with a diet of 100g fat / day.




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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with decompensated liver cirrhosis and who are admitted to hospital for this reason. Patients will be included prospectively and consecutively.
Criteria

Inclusion Criteria:

  1. Patients with histological diagnosis of CH or by clinical, analytical, ecographic or fibroscan criteria.
  2. Patients with decompensated HC (ascites, hepatic hydrothorax, hepatorenal syndrome, digestive bleeding due to portal hypertension or hepatic encephalopathy.
  3. Signature of informed consent
  4. Prevision of hospital admission for a minimum of 48 hours (for the correct completion of the marked triolein test and the collection of samples for fecal elastase)
  5. Age between 18 and 85 years.

Exclusion Criteria:

  1. Previous diagnosis of EPI
  2. Suspected biliary tract obstruction
  3. Need for high doses of laxative which makes it impossible to collect faecal samples correctly (> 5 dep / d secondary to laxatives)
  4. Patients who, due to their clinical situation, are unable to collaborate in the labeled triolein breath test
  5. Patients with inability to use the oral route.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03236038


Contacts
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Contact: Jordi S Sánchez-Delgado, M.D; PhD 627907988 jsanchezd@tauli.cat
Contact: Jordi Sánchez-Delgado, M.D; PhD 627907988 jorsandel@yahoo.es

Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
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Principal Investigator: Jordi Sánchez-Delgado, M.D; PhD Corporació Sanitària Parc Tauli

Additional Information:

Publications of Results:
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Responsible Party: Jordi Sanchez-Delgado, M.D; PhD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT03236038     History of Changes
Other Study ID Numbers: 2017536
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jordi Sanchez-Delgado, Corporacion Parc Tauli:
exocrine pancreatic insufficiency
liver cirrhosis
decompensated cirrhosis
malnutrition
prevalence

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Exocrine Pancreatic Insufficiency
Pathologic Processes
Liver Diseases
Digestive System Diseases
Pancreatic Diseases