Acute PancreatitisNCT03482921
Body Parameters as an Independent Predictor of Acute Pancreatitis
An observational study of Acute Pancreatitis, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
This study is to assess the predictive significance of visceral adipose tissue (VAT) and visceral adipose tissue /skeletal muscle tissue ratio (VAT/SMT ratio) for the prognosis in acute pancreatitis (AP) patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Pancreatitis
- How many people
- 1,662 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 22 Mar 2018
- How long will I take part?
- 7 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 100 years
- All sexes
- 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
- age<18years
- missing data in the electronic medical record
- history of AP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Body Parameters as an Independent Predictor of Acute Pancreatitis: A Propensity Score-matched Case-control Study
This study is to assess the predictive significance of visceral adipose tissue (VAT) and visceral adipose tissue /skeletal muscle tissue ratio (VAT/SMT ratio) for the prognosis in acute pancreatitis (AP) patients.
Read the detailed description
Acute pancreatitis (AP) is a sudden inflammation of the pancreas. However, one-fifth of patients may develop severe complications with a mortality between 10%-20% It remains a difficulty to find an effective method for prediction of severity of AP at early stage.
It is well-established that obesity (defined as body mass index[BMI]>30kg/m2 by the World Health Organization) is a risk factor for AP and increases the incidence of systemic complication, motality. There are a lot of parameters related to saropenic obesity, including areas of visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), skeletal muscle tissue (SMT), and VAT/SMT ratio. it is unclear which parameter is the best predictor of severe AP. Thus, this study is aimed to investigate the association between these parameters and AP severity and find the best predictor of AP.
- Conditions
- Acute Pancreatitis
- Medical subject headings
- Pancreatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparisons of variables according to AP severity
Comparisons of variables according to AP severity by one-way analysis of variance (ANOVA) and Likelihood Ratio
Measured: the physical examination data in the year of 2017
Relationships between VAT and severity outcomes Relationships between VAT and severity outcomes Relationships between VAT and severity outcomes Relationships between body parameters and severity outcomes
Relationships between VAT and severity outcomes by Likelihood Ratio
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 posted29 Mar 2018
- Study start1 Dec 2017
- Primary completion12 Feb 2018
- Study completion22 Mar 2018
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 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
- 7 Years
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
- NCT03482921
- Sponsor's protocol ID
- Ningbo4
- Status last verified
- Mar 2018
- First submitted
- 23 Mar 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xie J, Xu L, Pan Y, Li P, Liu Y, Pan Y, Xu L. Impact of visceral adiposity on severity of acute pancreatitis: a propensity score-matched analysis. BMC Gastroenterol. 2019 Jun 13;19(1):87. doi: 10.1186/s12876-019-1015-z.
PubMed 31195984
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Parameters as an Independent Predictor of Acute Pancreatitis: A Propensity Score-matched Case-control Study
- ClinicalTrials.gov ID
- NCT03482921
- Acronym / sponsor ID
- Ningbo4
- Conditions
- Acute Pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,662 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 12 Feb 2018 (actual)
- Study completion
- 22 Mar 2018 (actual)
- First posted
- 29 Mar 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.
This study is to assess the predictive significance of visceral adipose tissue (VAT) and visceral adipose tissue /skeletal muscle tissue ratio (VAT/SMT ratio) for the prognosis in acute pancreatitis (AP) patients.
Detailed description
Acute pancreatitis (AP) is a sudden inflammation of the pancreas. However, one-fifth of patients may develop severe complications with a mortality between 10%-20% It remains a difficulty to find an effective method for prediction of severity of AP at early stage.
It is well-established that obesity (defined as body mass index[BMI]>30kg/m2 by the World Health Organization) is a risk factor for AP and increases the incidence of systemic complication, motality. There are a lot of parameters related to saropenic obesity, including areas of visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), skeletal muscle tissue (SMT), and VAT/SMT ratio. it is unclear which parameter is the best predictor of severe AP. Thus, this study is aimed to investigate the association between these parameters and AP severity and find the best predictor of AP.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 7 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- 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 (3 listed)
- age<18years
- missing data in the electronic medical record
- history of AP
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 according to AP severity
Time frame: the physical examination data in the year of 2017
Comparisons of variables according to AP severity by one-way analysis of variance (ANOVA) and Likelihood Ratio
Relationships between VAT and severity outcomes Relationships between VAT and severity outcomes Relationships between VAT and severity outcomes Relationships between body parameters and severity outcomes
Time frame: the physical examination data in the year of 2017
Relationships between VAT and severity outcomes by Likelihood Ratio
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 29 Mar 2018.
- Derived from this study: PubMed 31195984Xie J, Xu L, Pan Y, Li P, Liu Y, Pan Y, Xu L. Impact of visceral adiposity on severity of acute pancreatitis: a propensity score-matched analysis. BMC Gastroenterol. 2019 Jun 13;19(1):87. doi: 10.1186/s12876-019-1015-z.
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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, 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 3 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 29 Mar 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?
Comparisons of variables according to AP severity (time frame: the physical examination data in the year of 2017). The study lists 2 primary outcomes in all. 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 NCT03482921, 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 29 Mar 2018.