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.
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.
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.
- Conditions
- Exocrine Pancreatic Insufficiency
- 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.
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.
- First posted1 Aug 2017
- Study start1 Oct 2017
- Primary completion1 Oct 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exocrine Pancreatic InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordi Sanchez-Delgado, Corporacion Parc Tauli
- Investigators
- Jordi Sánchez-Delgado, M.D; PhD, Principal investigator, Corporació Sanitària Parc Tauli
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Exocrine Pancreatic Insufficiency in Patients With Decompensated Cirrhosis
- ClinicalTrials.gov ID
- NCT03236038
- Acronym / sponsor ID
- (EPIIHC) / 2017536
- Conditions
- Exocrine Pancreatic Insufficiency
- Keywords
- exocrine pancreatic insufficiency, liver cirrhosis, decompensated cirrhosis, malnutrition, prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Labeled triolein urea breath testAlso: fecal elastaseThe 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. | Diagnostic test | – |
Primary outcome
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Results publication: PubMed 24713840Aoufi 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.
- Individual participant dataSharing planned: Undecided
Related trials for Exocrine Pancreatic Insufficiency
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingPhase 2
Phase 2 Study to Assess the Safety and Efficacy of ANG003
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
RecruitingObservational study
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
Exocrine Pancreatic Insuficiency
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordi Sánchez-Delgado, M.D; PhD principal investigator
Corporació Sanitària Parc Tauli
1 site in 1 country: see every site and its status.
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.