Prevalence of Exocrine Pancreatic Insufficiency in Patients With Decompensated Cirrhosis
Condition: Exocrine Pancreatic Insufficiency
MeSH terms: Liver Cirrhosis; Exocrine Pancreatic Insufficiency; Fibrosis
Study type: Observational [Patient Registry]

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
    

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.
    

Intervention name(s): Labeled triolein urea breath test
Intervention type(s): Diagnostic Test
Intervention description(s): 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 intervention name(s): fecal elastase
Observational model: Other
Time perspective: Prospective
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.
      
Keywords: exocrine pancreatic insufficiency; liver cirrhosis; decompensated cirrhosis; malnutrition; prevalence