Non-Alcoholic Fatty Pancreas DiseaseNCT03394378
The Impact of Non-Alcoholic Fatty Pancreas Disease on Outcome of Acute Pancreatitis
An observational study of Non-Alcoholic Fatty Pancreas Disease and Acute Pancreatitis, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
Obesity is a well-established risk factor for acute pancreatitis (AP). As for non-alcoholic fatty pancreas disease (NAFPD), it is evident that it is correlated with obesity. This is apparently the first study evaluating the association between NAFPD and severity of AP after taking into account several covariates. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-Alcoholic Fatty Pancreas Disease, Acute Pancreatitis
- How many people
- 1,662 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2017to 15 Dec 2017
- 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 100 years
- All sexes
- Adult, Older adult
Study population: Diagnosis criteria for AP were 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 normal, and (3) characteristic findings of AP on a CT scan
Who may be able to join
- diagnosed with AP
- age>18y
Who cannot join
- age<18y
- missing data in the electronic medical record
- prior attacks of AP
- without spleen
- with ambiguous pancreatic margin
Trial locations and contacts
1 site in 1 country.
About this study
Obesity is a well-established risk factor for acute pancreatitis (AP). As for non-alcoholic fatty pancreas disease (NAFPD), it is evident that it is correlated with obesity. This is apparently the first study evaluating the association between NAFPD and severity of AP after taking into account several covariates.
Read the detailed description
Acute pancreatitis (AP) is a common disease with a highly variable clinical course, which can range from a mild, self-limited disease to severe disease with a mortality rate of 10-20%. It is vital to distinguish severe cases early because they require more aggressive fluid resuscitation and early nutritional support.
Obesity is a well-established risk factor for acute pancreatitis (AP). It leads to ectopic fat accumulation in visceral organs, such as the liver, skeletal muscles, heart and pancreas.
Assuming that attenuation in the pancreas seen on unenhanced computed tomography (CT) scanning is inversely associated with severe outcomes in AP, we investigated the relationship between NAFPD and severity of AP and the significance of pancreas attenuation for the prognosis and mortality in AP patients. The result of this study suggest that decreased pancreas attenuation and P/S ratio are strong predictors of severe pancreatitis, mortality, systemic complication.
- Medical subject headings
- Pancreatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of characteristics and variables according to severity of AP.
Comparison of characteristics and variables according to severity of AP by One-Way Analysis of variance(ANOVA) and Pearson chi-square test.
Measured: the physical examination data in the year of 2017
The association between pancreas attenuation and ICU transfer, pancreatitis severity, systemic and local complications and prognostic scores (APACHE II scores, Ranson score, BISAP score and SIRS).
The association between pancreas attenuation and ICU transfer, pancreatitis severity, systemic and local complications and prognostic scores (APACHE II scores, Ranson score, BISAP score and SIRS) by Likelihood Ratio test.
Measured: the physical examination data in the year of 2017
BMI adjusted hazard ratios (HRs) and 95% CIs for the relationship between NAFPD and mortality of acute pancreatitis, evaluated by pancreas attenuation (HU), P/S ratio.
BMI adjusted hazard ratios (HRs) and 95% CIs for the relationship between NAFPD and mortality of acute pancreatitis, evaluated by pancreas attenuation (HU), P/S ratio by cox proportional hazards models.
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 posted9 Jan 2018
- Study start6 Nov 2017
- Primary completion3 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Pancreas DiseaseStudies 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
- Cross-sectional
- Enrolment
- 1,662 participants (actual)
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
- NCT03394378
- Sponsor's protocol ID
- Ningbo3
- Status last verified
- Jan 2018
- First submitted
- 3 Jan 2018
- Last updated
- 9 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Non-Alcoholic Fatty Pancreas Disease on Outcome of Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT03394378
- Acronym / sponsor ID
- Ningbo3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,662 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 3 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 9 Jan 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.
Obesity is a well-established risk factor for acute pancreatitis (AP). As for non-alcoholic fatty pancreas disease (NAFPD), it is evident that it is correlated with obesity. This is apparently the first study evaluating the association between NAFPD and severity of AP after taking into account several covariates.
Detailed description
Acute pancreatitis (AP) is a common disease with a highly variable clinical course, which can range from a mild, self-limited disease to severe disease with a mortality rate of 10-20%. It is vital to distinguish severe cases early because they require more aggressive fluid resuscitation and early nutritional support.
Obesity is a well-established risk factor for acute pancreatitis (AP). It leads to ectopic fat accumulation in visceral organs, such as the liver, skeletal muscles, heart and pancreas.
Assuming that attenuation in the pancreas seen on unenhanced computed tomography (CT) scanning is inversely associated with severe outcomes in AP, we investigated the relationship between NAFPD and severity of AP and the significance of pancreas attenuation for the prognosis and mortality in AP patients. The result of this study suggest that decreased pancreas attenuation and P/S ratio are strong predictors of severe pancreatitis, mortality, systemic complication.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Diagnosis criteria for AP were 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 normal, and (3) characteristic findings of AP on a CT scan
Key inclusion criteria (2 listed)
- diagnosed with AP
- age>18y
Key exclusion criteria (5 listed)
- age<18y
- missing data in the electronic medical record
- prior attacks of AP
- without spleen
- with 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
Comparison of characteristics and variables according to severity of AP.
Time frame: the physical examination data in the year of 2017
Comparison of characteristics and variables according to severity of AP by One-Way Analysis of variance(ANOVA) and Pearson chi-square test.
The association between pancreas attenuation and ICU transfer, pancreatitis severity, systemic and local complications and prognostic scores (APACHE II scores, Ranson score, BISAP score and SIRS).
Time frame: the physical examination data in the year of 2017
The association between pancreas attenuation and ICU transfer, pancreatitis severity, systemic and local complications and prognostic scores (APACHE II scores, Ranson score, BISAP score and SIRS) by Likelihood Ratio test.
BMI adjusted hazard ratios (HRs) and 95% CIs for the relationship between NAFPD and mortality of acute pancreatitis, evaluated by pancreas attenuation (HU), P/S ratio.
Time frame: the physical examination data in the year of 2017
BMI adjusted hazard ratios (HRs) and 95% CIs for the relationship between NAFPD and mortality of acute pancreatitis, evaluated by pancreas attenuation (HU), P/S ratio by cox proportional hazards models.
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 Jan 2018.
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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 Non-Alcoholic Fatty Pancreas Disease and Acute Pancreatitis, 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 9 Jan 2018. 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?
Comparison of characteristics and variables according to severity of AP. (time frame: the physical examination data in the year of 2017). The study lists 3 primary outcomes in all. 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 9 Jan 2018.