Prevalence of Exocrine Pancreatic Insufficiency in Patients With Decompensated Cirrhosis
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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.
Tarixlər
Son Doğrulandı: | 06/30/2017 |
İlk təqdim: | 07/24/2017 |
Təxmini qeydiyyat təqdim edildi: | 07/27/2017 |
İlk Göndərmə: | 07/31/2017 |
Son Yeniləmə Göndərildi: | 07/27/2017 |
Son Yeniləmə Göndərildi: | 07/31/2017 |
Həqiqi Təhsilin Başlama Tarixi: | 09/30/2017 |
Təxmini İlkin Tamamlanma Tarixi: | 09/30/2019 |
Təxmini İşin Tamamlanma Tarixi: | 02/29/2020 |
Vəziyyət və ya xəstəlik
Müdaxilə / müalicə
Diagnostic Test: Labeled triolein urea breath test
Faza
Uyğunluq Kriteriyaları
Təhsil üçün uyğun yaşlar | 18 Years Üçün 18 Years |
Təhsilə Uyğun Cinslər | All |
Nümunə götürmə metodu | Non-Probability Sample |
Sağlam Könüllüləri qəbul edir | Bəli |
Kriteriyalar | 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. |
Nəticə
İlkin nəticə tədbirləri
1. Prevalence of exocrine pancreatic insufficiency in decompensated alcoholic cirrhosis [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).]