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临床试验/NCT03236038
NCT03236038已完成不适用

Prevalence of Exocrine Pancreatic Insufficiency in Patients With Decompensated Cirrhosis

Corporacion Parc Tauli1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2017年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
125
试验地点
1
主要终点
Prevalence of exocrine pancreatic insufficiency in decompensated alcoholic cirrhosis

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Prevalence of exocrine pancreatic insufficiency in decompensated alcoholic cirrhosis

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Corporacion Parc Tauli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jordi Sanchez-Delgado

M.D; PhD

Corporacion Parc Tauli

研究点 (1)

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