Acute PancreatitisNCT03566173
Association Between Nonalcoholic Fatty Liver Disease and Acute Pancreatitis
An observational study of Acute Pancreatitis and Nonalcoholic Fatty Liver Disease, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
The early evaluation of AP severity are vital. Previous studies have shown non-alcoholic fatty liver disease (NAFLD) is associated with severity of acute pancreatitis (AP). This study is aimed to investigate the relationship between NAFLD and AP severity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Pancreatitis, Nonalcoholic Fatty Liver Disease
- How many people
- 1,662 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2018to 15 Apr 2018
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Diagnosis criteria for AP was defined as the presence of at least 2 of the 3 following factors: (1) abdominal pain characteristic of AP; (2) serum amylase and/or lipase levels≥3 times the upper limit of the normal level, and (3) characteristic findings of AP on a CT scanning.
Who may be able to join
- diagnosed with AP
- age >18 years
Who cannot join
- an age of <18 years
- without complete data and CT scans
- previous splenectomy or hepatectomy
- a past history of AP
- an ambiguous pancreatic margin
Trial locations and contacts
1 site in 1 country.
About this study
The early evaluation of AP severity are vital. Previous studies have shown non-alcoholic fatty liver disease (NAFLD) is associated with severity of acute pancreatitis (AP). This study is aimed to investigate the relationship between NAFLD and AP severity.
Read the detailed description
Acute pancreatitis (AP) is a potentially lethal disease capable of wide clinical variation. Severe acute pancreatitis (SAP) is devastating, with a mortality rate ranging from 10% to as high as 85%. So it's important to identify severe patients which require aggressive early treatment and prolonged specialist care. There are a lot of multifactorial scorings and specific laboratory tests in predicting AP severity, such as Ranson's, Acute Physiology and Chronic Health Examination (APACHE)-II, serum Interleukin-6 (IL-6), and C-reactive protein (CRP) level. However, they have limitations in predicting outcomes of AP patients. The biochemical markers are not accurate enough. Ranson's scores were calculated after 48 hours of admission. Their practical utilization as predictors of severity is tough. Novel prognostic biomarker is needed to further develop for prognosis in AP patients.
Nonalcoholic fatty liver disease (NAFLD) refers to fat deposition and oxidative stress of free radicals in hepatocytes. NAFLD is the most common chronic liver disease worldwide. The prevalence averages 30% in developed countries, and estimated to be 10% in developing countries. Its presentation ranges from asymptomatic steatosis to fibrosis, and cirrhosis with 3-5%. It is evident clinically with increased risk of developing obesity, cardiovascular diseases (CVD), hyperlipidaemia, and type 2 diabetes mellitus (T2DM). Acting as an endocrine organ, the liver is the source of adipokines and inflammatory cytokines. Alterations in the production and secretion are increased in patients with NAFLD. It is strongly related to insulin resistance (IR) and metabolic disorders. Previous studies noted that NAFLD is closely related to severity of AP. CT scans are usually performed at admission to diagnose AP severity, which are also helpful to assess NAFLD. It could act as a valuable prognostic factor in AP patients and help to recognize potential severe patients.
However, no clear pathways could explain the association between NAFLD and AP at present. Besides, the data is scarce. More research will pay more attention to this topic. In this study, the investigators investigated the association between NAFLD and AP.
- Medical subject headings
- Pancreatitis, Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparisons of variables (age in years, BMI in kg/m2, pancreas attenuation in HU) on the basis of AP severity
Comparisons of variables on the basis of AP severity by one-way analysis of variance (ANOVA)
Measured: the physical examination data in the year of 2017
Secondary outcomes (1)
Association between NAFLD and severity outcomes in AP patients
Association between liver/spleen attenuation (L/S) ratio in Hounsfield units (HU) and severity outcomes in AP patients by Cox regression analysis
Measured: the physical examination data in the year of 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start10 Mar 2018
- Primary completion1 Apr 2018
- Study completion15 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,662 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Xu, Dr, Principal investigator, Department of gastroenterology,Ningbo No.1 Hospital, Ningbo, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566173
- Sponsor's protocol ID
- Ningbo5
- Status last verified
- Apr 2019
- First submitted
- 25 May 2018
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Nonalcoholic Fatty Liver Disease and Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT03566173
- Acronym / sponsor ID
- Ningbo5
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,662 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 10 Mar 2018 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 15 Apr 2018 (actual)
- First posted
- 25 Jun 2018 (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.
The early evaluation of AP severity are vital. Previous studies have shown non-alcoholic fatty liver disease (NAFLD) is associated with severity of acute pancreatitis (AP). This study is aimed to investigate the relationship between NAFLD and AP severity.
Detailed description
Acute pancreatitis (AP) is a potentially lethal disease capable of wide clinical variation. Severe acute pancreatitis (SAP) is devastating, with a mortality rate ranging from 10% to as high as 85%. So it's important to identify severe patients which require aggressive early treatment and prolonged specialist care. There are a lot of multifactorial scorings and specific laboratory tests in predicting AP severity, such as Ranson's, Acute Physiology and Chronic Health Examination (APACHE)-II, serum Interleukin-6 (IL-6), and C-reactive protein (CRP) level. However, they have limitations in predicting outcomes of AP patients. The biochemical markers are not accurate enough. Ranson's scores were calculated after 48 hours of admission. Their practical utilization as predictors of severity is tough. Novel prognostic biomarker is needed to further develop for prognosis in AP patients.
Nonalcoholic fatty liver disease (NAFLD) refers to fat deposition and oxidative stress of free radicals in hepatocytes. NAFLD is the most common chronic liver disease worldwide. The prevalence averages 30% in developed countries, and estimated to be 10% in developing countries. Its presentation ranges from asymptomatic steatosis to fibrosis, and cirrhosis with 3-5%. It is evident clinically with increased risk of developing obesity, cardiovascular diseases (CVD), hyperlipidaemia, and type 2 diabetes mellitus (T2DM). Acting as an endocrine organ, the liver is the source of adipokines and inflammatory cytokines. Alterations in the production and secretion are increased in patients with NAFLD. It is strongly related to insulin resistance (IR) and metabolic disorders. Previous studies noted that NAFLD is closely related to severity of AP. CT scans are usually performed at admission to diagnose AP severity, which are also helpful to assess NAFLD. It could act as a valuable prognostic factor in AP patients and help to recognize potential severe patients.
However, no clear pathways could explain the association between NAFLD and AP at present. Besides, the data is scarce. More research will pay more attention to this topic. In this study, the investigators investigated the association between NAFLD and AP.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Diagnosis criteria for AP was defined as the presence of at least 2 of the 3 following factors: (1) abdominal pain characteristic of AP; (2) serum amylase and/or lipase levels≥3 times the upper limit of the normal level, and (3) characteristic findings of AP on a CT scanning.
Key inclusion criteria (2 listed)
- diagnosed with AP
- age >18 years
Key exclusion criteria (5 listed)
- an age of <18 years
- without complete data and CT scans
- previous splenectomy or hepatectomy
- a past history of AP
- an ambiguous pancreatic margin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparisons of variables (age in years, BMI in kg/m2, pancreas attenuation in HU) on the basis of AP severity
Time frame: the physical examination data in the year of 2017
Comparisons of variables on the basis of AP severity by one-way analysis of variance (ANOVA)
1 secondary outcome
Association between NAFLD and severity outcomes in AP patients
Time frame: the physical examination data in the year of 2017
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 1 May 2019.
- Individual participant dataSharing planned: No
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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.
Lei Xu, Dr principal investigator
Department of gastroenterology,Ningbo No.1 Hospital, Ningbo, China
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 Acute Pancreatitis and Nonalcoholic Fatty Liver Disease, run by Ningbo No. 1 Hospital at 1 site in China.
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 2 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 1 May 2019. 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 China. 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?
Comparisons of variables (age in years, BMI in kg/m2, pancreas attenuation in HU) on the basis of AP severity (time frame: the physical examination data in the year of 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.