AcuteNCT06653205
Prediction of Acute Pancreatitis Outcome
An observational study of Acute and Pancreatitis, run by Assiut University.
Trial summary
Aim of study prediction of acute pancreatitis outcome by using cheap and available laboratory resources Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute, Pancreatitis
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patient complaint of abdominal pain ,more than 18 years old,not known to have liver ,renal or malignant disease, typical abdominal ultrasound and computed tomography with findings of acute pancreatitis
Who may be able to join
- Patients age >18 years old Serum amylase >3 times the upper limit of normal. abdominal pain consistent with acute pancreatitis. Typical abdominal ultrasonography and tomography findings in the routine imaging of the patients were accepted as acute pancreatitis.
- Patient complaint of abdominal pain -
Who cannot join
- liver diseases patients renal diseases patients malignancy patients
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Systemic Inflammation Response Index and Systemic Immune Inflammation Index and Prediction of Clinical Outcome in Acute Pancreatitis
Aim of study prediction of acute pancreatitis outcome by using cheap and available laboratory resources
Read the detailed description
Acute pancreatitis (AP) is a sudden inflammation of the pancreas that can vary from mild, self-resolving episodes to severe, potentially fatal conditions(1). Clinically, AP is classified into mild acute pancreatitis and severe acute pancreatitis (SAP), and SAP patients are described by multi-organ failure and high mortality rates(2). The mortality rate of acute pancreatitis varies, ranging from 3% in cases of mild edematous pancreatitis to as high as 20% in patients with pancreatic necrosis(3).The progression of AP can lead to systemic complications, making early prediction of clinical outcomes essential for effective management(4).
In recent years, there has been growing interest in identifying reliable biomarkers that can predict the severity and outcomes of acute pancreatitis(5). Systemic inflammation is a key factor in the pathophysiology of acute pancreatitis, often leading to systemic inflammatory response syndrome (SIRS) and subsequent organ dysfunction(6). Consequently, assessing systemic inflammation has become a crucial aspect of managing AP patients(7).
The Systemic Inflammation Response Index (SIRI) is recognized in the literature as an inflammatory marker that combines routine blood parameters, such as neutrophils, monocytes, and lymphocytes(8). Both SIRI and the Systemic Immune Inflammation Index (SII) are emerging as novel biomarkers for systemic inflammation(9). SIRI is calculated using neutrophil, monocyte, and lymphocyte counts, while SII is based on platelet, neutrophil, and lymphocyte counts(10)
- Conditions
- Acute, Pancreatitis
- Keywords
- Acute pancreatitis, Outcome
- Medical subject headings
- Pancreatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality and severity of acute pancreatitis
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
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 AcuteStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Ayman Wahba, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653205
- Sponsor's protocol ID
- Acute pancreatitis outcome
- Status last verified
- Oct 2024
- First submitted
- 20 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Biyik M, Biyik Z, Asil M, Keskin M. Systemic Inflammation Response Index and Systemic Immune Inflammation Index Are Associated with Clinical Outcomes in Patients with Acute Pancreatitis? J Invest Surg. 2022 Aug;35(8):1613-1620. doi: 10.1080/08941939.2022.2084187. Epub 2022 Jun 5.
PubMed 35855674
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Inflammation Response Index and Systemic Immune Inflammation Index and Prediction of Clinical Outcome in Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT06653205
- Acronym / sponsor ID
- Acute pancreatitis outcome
- Conditions
- Acute, Pancreatitis
- Keywords
- Acute pancreatitis, Outcome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 Oct 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.
Aim of study prediction of acute pancreatitis outcome by using cheap and available laboratory resources
Detailed description
Acute pancreatitis (AP) is a sudden inflammation of the pancreas that can vary from mild, self-resolving episodes to severe, potentially fatal conditions(1). Clinically, AP is classified into mild acute pancreatitis and severe acute pancreatitis (SAP), and SAP patients are described by multi-organ failure and high mortality rates(2). The mortality rate of acute pancreatitis varies, ranging from 3% in cases of mild edematous pancreatitis to as high as 20% in patients with pancreatic necrosis(3).The progression of AP can lead to systemic complications, making early prediction of clinical outcomes essential for effective management(4).
In recent years, there has been growing interest in identifying reliable biomarkers that can predict the severity and outcomes of acute pancreatitis(5). Systemic inflammation is a key factor in the pathophysiology of acute pancreatitis, often leading to systemic inflammatory response syndrome (SIRS) and subsequent organ dysfunction(6). Consequently, assessing systemic inflammation has become a crucial aspect of managing AP patients(7).
The Systemic Inflammation Response Index (SIRI) is recognized in the literature as an inflammatory marker that combines routine blood parameters, such as neutrophils, monocytes, and lymphocytes(8). Both SIRI and the Systemic Immune Inflammation Index (SII) are emerging as novel biomarkers for systemic inflammation(9). SIRI is calculated using neutrophil, monocyte, and lymphocyte counts, while SII is based on platelet, neutrophil, and lymphocyte counts(10)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient complaint of abdominal pain ,more than 18 years old,not known to have liver ,renal or malignant disease, typical abdominal ultrasound and computed tomography with findings of acute pancreatitis
Key inclusion criteria (2 listed)
- Patients age >18 years old Serum amylase >3 times the upper limit of normal. abdominal pain consistent with acute pancreatitis. Typical abdominal ultrasonography and tomography findings in the routine imaging of the patients were accepted as acute pancreatitis.
- Patient complaint of abdominal pain -
Key exclusion criteria (2 listed)
- liver diseases patients renal diseases patients malignancy patients
- -
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
Mortality and severity of acute pancreatitis
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Background: PubMed 35855674Biyik M, Biyik Z, Asil M, Keskin M. Systemic Inflammation Response Index and Systemic Immune Inflammation Index Are Associated with Clinical Outcomes in Patients with Acute Pancreatitis? J Invest Surg. 2022 Aug;35(8):1613-1620. doi: 10.1080/08941939.2022.2084187. Epub 2022 Jun 5.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute and Pancreatitis, run by Assiut University.
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 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: opening soon, as of the sponsor's last update on 22 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mina Ayman Wahba, Resident physician (+2001208790328, Mena.16266257@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality and severity of acute pancreatitis (time frame: Baseline). 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 NCT06653205, 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 22 Oct 2024.