Acute PancreatitisNCT06464887
A Predictive Model for Recurrent Acute Pancreatitis
An observational study of Acute Pancreatitis, run by Qinghao Wang.
Trial summary
The goal of this observational study is to learn about recurrent acute pancreatitis (RAP) .The main questions it aims to answer are: 1. What are the risk factors for RAP? 2. How to predict RAP? All patients with acute pancreatitis will be given standardized treatment for the condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- How many people
- 659 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Jun 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We collected data from the Medical Information Mart for Intensive Care-IV (MIMIC-IV) database and from patients with acute pancreatitis in the Department of Gastroenterology of Clinical Medical College of Yangzhou University between January 2016 and December 2017, forming the primary and validation cohort, respectively.
Who may be able to join
- Meeting the diagnostic criteria of acute pancreatitis (AP)
- Age ≥18 years
- Systematic examination and diagnostic information were available after admission
Who cannot join
- Not the first episode of AP
- The duration of hospital stay was less than 24 hours
- Died within the first episode of AP
- A history of chronic pancreatitis or tumor
- Pregnancy
About this study
Official title: Construction and Validation of an Early Prediction Nomogram for Recurrent Acute Pancreatitis Based on the MIMIC Database
The goal of this observational study is to learn about recurrent acute pancreatitis (RAP) .The main questions it aims to answer are:
- What are the risk factors for RAP?
- How to predict RAP?
All patients with acute pancreatitis will be given standardized treatment for the condition.
The researchers will compare the RAP group with the non-RAP group to find the risk factors for RAP.
Read the detailed description
Investigators retrospectively collected data from the Medical Information Mart for Intensive Care-IV (MIMIC-IV) database and from patients with acute pancreatitis (AP) in the Department of Gastroenterology of Clinical Medical College of Yangzhou University between January 2016 and December 2017, forming the primary and validation cohort, respectively.
- Conditions
- Acute Pancreatitis
- Keywords
- Recurrent acute pancreatitis, Prediction
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Recurrent acute pancreatitis | Not described | |
| Non-recurrent acute pancreatitis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience Recurrent Acute Pancreatitis
Recurrent acute pancreatitis was defined as two or more confirmed episodes of acute pancreatitis, excluding chronic pancreatitis, with an interval of more than 3 months between attacks, and complete resolution of symptoms during the inter-episodic periods.
Measured: From admission to 3 years after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Jan 2016
- Primary completion31 Dec 2017
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Retrospective
- Enrolment
- 659 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qinghao Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qinghao Wang, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464887
- Sponsor's protocol ID
- 20200047
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Johnson AEW, Bulgarelli L, Shen L, Gayles A, Shammout A, Horng S, Pollard TJ, Hao S, Moody B, Gow B, Lehman LH, Celi LA, Mark RG. MIMIC-IV, a freely accessible electronic health record dataset. Sci Data. 2023 Jan 3;10(1):1. doi: 10.1038/s41597-022-01899-x.
PubMed 36596836Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
PubMed 23100216
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Validation of an Early Prediction Nomogram for Recurrent Acute Pancreatitis Based on the MIMIC Database
- ClinicalTrials.gov ID
- NCT06464887
- Acronym / sponsor ID
- 20200047
- Conditions
- Acute Pancreatitis
- Keywords
- Recurrent acute pancreatitis, Prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 659 participants (actual)
- Lead sponsor
- Qinghao WangUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 18 Jun 2024 (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 goal of this observational study is to learn about recurrent acute pancreatitis (RAP) .The main questions it aims to answer are:
- What are the risk factors for RAP?
- How to predict RAP?
All patients with acute pancreatitis will be given standardized treatment for the condition.
The researchers will compare the RAP group with the non-RAP group to find the risk factors for RAP.
Detailed description
Investigators retrospectively collected data from the Medical Information Mart for Intensive Care-IV (MIMIC-IV) database and from patients with acute pancreatitis (AP) in the Department of Gastroenterology of Clinical Medical College of Yangzhou University between January 2016 and December 2017, forming the primary and validation cohort, respectively.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recurrent acute pancreatitis | – | – |
| Non-recurrent acute pancreatitis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We collected data from the Medical Information Mart for Intensive Care-IV (MIMIC-IV) database and from patients with acute pancreatitis in the Department of Gastroenterology of Clinical Medical College of Yangzhou University between January 2016 and December 2017, forming the primary and validation cohort, respectively.
Key inclusion criteria (3 listed)
- Meeting the diagnostic criteria of acute pancreatitis (AP)
- Age ≥18 years
- Systematic examination and diagnostic information were available after admission
Key exclusion criteria (5 listed)
- Not the first episode of AP
- The duration of hospital stay was less than 24 hours
- Died within the first episode of AP
- A history of chronic pancreatitis or tumor
- Pregnancy
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
Number of Participants Who Experience Recurrent Acute Pancreatitis
Time frame: From admission to 3 years after discharge.
Recurrent acute pancreatitis was defined as two or more confirmed episodes of acute pancreatitis, excluding chronic pancreatitis, with an interval of more than 3 months between attacks, and complete resolution of symptoms during the inter-episodic periods.
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 24 Jun 2024.
- Background: PubMed 36596836Johnson AEW, Bulgarelli L, Shen L, Gayles A, Shammout A, Horng S, Pollard TJ, Hao S, Moody B, Gow B, Lehman LH, Celi LA, Mark RG. MIMIC-IV, a freely accessible electronic health record dataset. Sci Data. 2023 Jan 3;10(1):1. doi: 10.1038/s41597-022-01899-x.
- Background: PubMed 23100216Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by Qinghao Wang.
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 3 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 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of Participants Who Experience Recurrent Acute Pancreatitis (time frame: From admission to 3 years after discharge.). 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 NCT06464887, which also lists 2 linked publications.
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 24 Jun 2024.