Acute PancreatitisNCT03282253
Elevated Stearoyl-CoA Desaturase-1 Expression Predicts the Disease Severity of Severe Acute Pancreatitis
An observational study of Acute Pancreatitis and Organ Failure, Multiple, run by Nanjing University School of Medicine.
Trial summary
In this study, the investgatiors aimed to investigate the associations between serum levels of stearoyl-CoA desaturase-1（SCD-1） and the disease severity as well as the presence of adverse clinical events, such as local complications, organ failure, mortality and so on.In this prospective study, participants were… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pancreatitis, Organ Failure, Multiple
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 30 Jun 2019
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with the diagnosis of acute pancreatitis (Atlanta standard), abdominal pain occurred within one week of admission; we intended to include the severer cases (APACHEII score is more than 8 and Ranson score is greater than 3).
Who may be able to join
- Diagnosis of acute pancreatitis (Atlanta standard), abdominal pain occurred within one week of admission;
- APACHEII score is more than 8 and Ranson score is greater than 3;
- Age 18-75;
- Obtaining informed consent.
Who cannot join
- Pregnancy pancreatitis;
- Patients with the following disease history: severe cardiac, pulmonary, renal, liver function insufficiency or immunodeficiency disease.
About this study
Official title: Elevated Stearoyl-CoA Desaturase-1 Expression Predicts the Disease Severity and Clinical Outcomes of Severe Acute Pancreatitis
In this study, the investgatiors aimed to investigate the associations between serum levels of stearoyl-CoA desaturase-1（SCD-1） and the disease severity as well as the presence of adverse clinical events, such as local complications, organ failure, mortality and so on.In this prospective study, participants were divided into two groups based on serum SCD-1 concentration on admission and prospectively observe the disease severity and clinical outcomes of them.
- Conditions
- Acute Pancreatitis, Organ Failure, Multiple
- Medical subject headings
- Pancreatitis, Multiple Organ Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence rate of infected pancreatic necrosis
Measured: 2-4 week after disease onset
Secondary outcomes (2)
the incidence rate of organ failure
the incidence rate of organ failure (transient or persistent)
Measured: 1-2 week after disease onset
the incidence rate of local complications
acute peripancreatic fluid collections, pancreatic pseudocycts, acute necrotic collections and walled-off necrosis
Measured: 1-2 week after disease onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Jan 2018 (estimated)
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Jun 2019 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiqin Li, Nanjing University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282253
- Sponsor's protocol ID
- ESCDEPDSSAP
- Status last verified
- Nov 2017
- First submitted
- 12 Sep 2017
- Last updated
- 27 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elevated Stearoyl-CoA Desaturase-1 Expression Predicts the Disease Severity and Clinical Outcomes of Severe Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT03282253
- Acronym / sponsor ID
- ESCDEPDSSAP
- Conditions
- Acute Pancreatitis, Organ Failure, Multiple
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 13 Sep 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.
In this study, the investgatiors aimed to investigate the associations between serum levels of stearoyl-CoA desaturase-1（SCD-1） and the disease severity as well as the presence of adverse clinical events, such as local complications, organ failure, mortality and so on.In this prospective study, participants were divided into two groups based on serum SCD-1 concentration on admission and prospectively observe the disease severity and clinical outcomes of them.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with the diagnosis of acute pancreatitis (Atlanta standard), abdominal pain occurred within one week of admission; we intended to include the severer cases (APACHEII score is more than 8 and Ranson score is greater than 3).
Key inclusion criteria (4 listed)
- Diagnosis of acute pancreatitis (Atlanta standard), abdominal pain occurred within one week of admission;
- APACHEII score is more than 8 and Ranson score is greater than 3;
- Age 18-75;
- Obtaining informed consent.
Key exclusion criteria (2 listed)
- Pregnancy pancreatitis;
- Patients with the following disease history: severe cardiac, pulmonary, renal, liver function insufficiency or immunodeficiency disease.
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
the incidence rate of infected pancreatic necrosis
Time frame: 2-4 week after disease onset
2 secondary outcomes
the incidence rate of organ failure
Time frame: 1-2 week after disease onset
the incidence rate of local complications
Time frame: 1-2 week after disease onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
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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 and Organ Failure, Multiple, run by Nanjing University School of Medicine.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Nov 2017. 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?
Results are not available in the source record.
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?
the incidence rate of infected pancreatic necrosis (time frame: 2-4 week after disease onset). 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 27 Nov 2017; AzTrials last refreshed its copy on 31 Oct 2026.