AzTrials
AzTrials

Exocrine Pancreatic Insufficiency(EPIIHC)NCT03236038

Prevalence of Exocrine Pancreatic Insufficiency in Patients With Decompensated Cirrhosis

An observational study of Exocrine Pancreatic Insufficiency, run by Corporacion Parc Tauli at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Exocrine Pancreatic Insufficiency
What is being tested?
Labeled triolein urea breath test
How many people
125 participants
Where
1 siteSpain
Study dates
1 Oct 2017to 31 Dec 2019
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with decompensated liver cirrhosis and who are admitted to hospital for this reason. Patients will be included prospectively and consecutively.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Parc Tauli Hospital

    Barcelona, 28208

Other trials in Spain

About this study

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.

Read more

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

Read the detailed description

Exocrine pancreatic insufficiency (EPI) is defined as the inability of the pancreas to perform a normal digestive function. Habitually, it occurs as a result of a severe reduction in the secretion of pancreatic enzymes, although - less frequently - it may be due to the inability of these enzymes to perform their function. Clinically, it has a very broad spectrum of presentation with abdominal discomforts, malnutrition, chronic diarrhea and, in severe cases, steatorrhea. It must be said, however, that it is not until the disease is very evolved with a pancreatic function very deteriorated (more than 90%) that steatorrhea becomes clinically evident. In addition, the onset of symptoms triggered by the intake of fats makes these patients adapt their diet, often unconsciously, so it is not uncommon to find patients with EPI and constipation.

To establish the diagnosis of IPE, different clinical tests are used. There are direct methods or invasive (secretin stimulation test, secretin-cerulein Lundh test) and noninvasive or indirect methods (coefficient of fat absorption, fecal elastase, fecal chymotrypsin activity, the pancreoleuril test, test with paraaminobenzoic acid and marked triolein test) are, in general, more accessible to the usual clinical practice.

Regarding etiology, the most frequent cause of EPI is chronic pancreatitis, an entity that is closely linked to chronic alcohol consumption. On the one hand, it should be noted that alcohol is a common etiologic factor to both pathogenesis of pancreatic and liver affections. On the other hand, it is well known that the liver and pancreas have a close relationship with regard to their anatomy and physiology. The pancreatic duct and the coledocus bind to the level of the Vater papilla, so that their contents are mixed.

Patients with EPI have severe malnutrition, a factor which increases the morbidity and mortality. Therefore, adequately replacing nutritional deficits by enzyme replacement therapy contributes significantly to decrease the complications, the hospital stays and the mortality. It could increase the quality of life of the patients. In addition, patients suffering from liver cirrhosis have other complications arising from malnutrition, as ascites that could be benefited from the improvement of the nutritional profile by enzyme replacement therapy detected in case of EPI. That is why we believe that our study could contribute to improving patient management with decompensated liver cirrhosis.

The objective of the study is to assess the prevalence of exocrine pancreatic insufficiency EPI in patients with decompensated alcoholic liver cirrhosis.

This is an epidemiological, unicentral, cross-sectional study that will be carried out within the hospital setting from October '17 to October'19.

Patients diagnosed with liver cirrrhosis and enter the hepatology unit for clinical decompensation (sd hepatorenal, ascitic decompensation, hepatic encephalopathy, gastrointestinal bleeding stable) will be included .

The investigators will collect demographic, epidemiology, analytic and clinical data. Anthropometric parameters such as tricipital fold, weight and size, will also be measured, which will allow the calculation of body mass index (BMI).

In order to diagnose the presence of IPE, the breath test with triolein marked with 13C (Pancreo-Kit®) will be performed. The study consists of a delay of 8 hours (overnight) and later obtaining a basal sample through exhalation of air in a tube. Subsequently, a substrate (foods with marked triolein) will be administered to the patient and after 30 minutes, it will have to exhale air in a tube every 30 minutes for a total of 6 hours, thus obtaining a total of 13 samples.

Blood tests will also be performed on all patients to assess their nutritional status (Hg, albumin, prealbumin, total proteins, cholesterol (HDL / LDL), bilirubin, prothrombin time, triglycerides, liposoluble Vitamins A, D, E and K; Vitamins B1, B12; calcium, phosphorus and magnesium), Hb glucose and collect a sample of solid stool isolated for the determination of the fecal elastase.

Being tested
Labeled triolein urea breath test
Keywords
exocrine pancreatic insufficiency, liver cirrhosis, decompensated cirrhosis, malnutrition, prevalence
Medical subject headings
Exocrine Pancreatic Insufficiency, Liver Cirrhosis, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Labeled triolein urea breath testDiagnostic test

    Also called fecal elastase

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2017
  2. Study start1 Oct 2017
  3. Primary completion1 Oct 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
125 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03236038
Sponsor's protocol ID
2017536
Acronym
(EPIIHC)
Status last verified
Dec 2020
First submitted
25 Jul 2017
Last updated
9 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 24713840

Questions about this trial

What is this clinical trial studying?

An observational study of Exocrine Pancreatic Insufficiency, run by Corporacion Parc Tauli at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03236038, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in