Prevalence of Exocrine Pancreatic Insufficiency in Patients With Decompensated Cirrhosis

NCT03236038 | Completed

• 1 other identifier: 2017536
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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

Conditions

Exocrine Pancreatic Insufficiency

Keywords

exocrine pancreatic insufficiency; liver cirrhosis; decompensated cirrhosis; malnutrition; prevalence

Outcome Measures

Primary Outcomes (1)

• Prevalence of exocrine pancreatic insufficiency in decompensated alcoholic cirrhosis

  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.

  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).

Interventions

Labeled triolein urea breath test DIAGNOSTIC_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.

Also known as: fecal elastase

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with histological diagnosis of CH or by clinical, analytical, ecographic or fibroscan criteria.
• Patients with decompensated HC (ascites, hepatic hydrothorax, hepatorenal syndrome, digestive bleeding due to portal hypertension or hepatic encephalopathy.
• Signature of informed consent
• 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)
• Age between 18 and 85 years.

You may not qualify if:

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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Parc Tauli Hospital

Barcelona, 28208, Spain

Location

Related Publications (1)

• Aoufi Rabih S, Garcia Agudo R, Legaz Huidobro ML, Ynfante Ferrus M, Gonzalez Carro P, Perez Roldan F, Ruiz Carrillo F, Tenias Burillo JM. Exocrine pancreatic insufficiency and chronic pancreatitis in chronic alcoholic liver disease: coincidence or shared toxicity? Pancreas. 2014 Jul;43(5):730-4. doi: 10.1097/MPA.0000000000000085.

  PMID: 24713840 RESULT

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency; Liver Cirrhosis; Malnutrition

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Jordi Sánchez-Delgado, M.D; PhD

  Corporació Sanitària Parc Tauli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D; PhD

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: August 1, 2017
• Study Start: October 1, 2017
• Primary Completion: October 1, 2019
• Study Completion: December 31, 2019
• Last Updated: December 9, 2020

Record last verified: 2020-12

Locations

ES (1)