Acute PancreatitisNCT04553783
Exploration of Blood Biomarkers, Including Whole Blood Viscosity as a Prognostic Factor for Acute Pancreatitis
An observational study of Acute Pancreatitis, run by In Seok Lee at 1 site in South Korea.
Trial summary
This study aims to evaluate the usefulness of blood viscosity as a prognostic factor in patients with acute pancreatitis. The study design is a single-arm prospective cohort observational study. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Acute Pancreatitis
- How many people
- 137 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Mar 2020to May 2023
- 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 19 to 70 years
- All sexes
- Adult, Older adult
Study population: Patients between 19 and 70 years of age with acute pancreatitis, excluding post-ERCP pancreatitis.
Who may be able to join
- Age 19-70 years old
- Acute pancreatitis
Who cannot join
- Post-Endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St. Mary's hospital
Seoul, 06591
Young Hoon Choi, MD, MS, 82-2-2258-6020, crzyzs@naver.com
About this study
This study aims to evaluate the usefulness of blood viscosity as a prognostic factor in patients with acute pancreatitis. The study design is a single-arm prospective cohort observational study. Blood biomarkers including blood viscosity, C-reactive protein, hematocrit, and phosphate are measured and the correlation with the severity of acute pancreatitis will be analyzed.
Read the detailed description
Several scoring systems are used to evaluate the prognosis of acute pancreatitis, but they are rather complicated and clinically less useful. Blood viscosity is associated with hematocrit and inflammatory factors known to be related to the prognosis of acute pancreatitis, and our group's previous study which is not yet published showed that blood viscosity better predicts severe acute pancreatitis than other single factors such as C-reative protein. Therefore, this study aims to prospectively evaluate the usefulness of blood viscosity as a prognostic factor for acute pancreatitis. During the study period, the study is conducted on patients with acute pancreatitis between the ages of 19 and 70, and patients with acute pancreatitis after ERCP are excluded. Blood viscosities at initial and 24 hours after hospitalization, and serum phosphate, which have shown potential as a predictor of severity in post-ERCP pancreatitis in previous studies are measured. The association of these blood biomarkers with the severity of acute pancreatitis will be analyzed and compared with hematocrit, C-reactive protein, etc., which are known as a single prognostic predictor of acute pancreatitis.
- Conditions
- Acute Pancreatitis
- Medical subject headings
- Pancreatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of severity of acute pancreatitis using initial blood viscosity
Evaluate initial blood viscosity as a predictor of the severity of acute pancreatitis
Measured: 48hours after admission
Secondary outcomes (2)
Prediction of severity of acute pancreatitis using blood viscosity change after 24hours
Prediction of severity of acute pancreatitis using blood viscosity change after 24hours
Measured: 24hours after admission
Prediction of severity of acute pancreatitis using serum phosphate
Prediction of severity of acute pancreatitis using serum phosphate
Measured: 48hours after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start10 Mar 2020
- Primary completionMay 2022 (estimated)
- Study completionMay 2023 (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
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- In Seok Lee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, In Seok Lee, Seoul St. Mary's Hospital
- Investigators
- In Seok Lee, MD, PhD, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553783
- Sponsor's protocol ID
- KC20OISI0022
- Status last verified
- Sep 2020
- First submitted
- 3 Jun 2020
- Last updated
- 17 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Blood Biomarkers, Including Whole Blood Viscosity as a Prognostic Factor for Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT04553783
- Acronym / sponsor ID
- KC20OISI0022
- Conditions
- Acute Pancreatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- In Seok LeeUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 17 Sep 2020 (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 aims to evaluate the usefulness of blood viscosity as a prognostic factor in patients with acute pancreatitis. The study design is a single-arm prospective cohort observational study. Blood biomarkers including blood viscosity, C-reactive protein, hematocrit, and phosphate are measured and the correlation with the severity of acute pancreatitis will be analyzed.
Detailed description
Several scoring systems are used to evaluate the prognosis of acute pancreatitis, but they are rather complicated and clinically less useful. Blood viscosity is associated with hematocrit and inflammatory factors known to be related to the prognosis of acute pancreatitis, and our group's previous study which is not yet published showed that blood viscosity better predicts severe acute pancreatitis than other single factors such as C-reative protein. Therefore, this study aims to prospectively evaluate the usefulness of blood viscosity as a prognostic factor for acute pancreatitis. During the study period, the study is conducted on patients with acute pancreatitis between the ages of 19 and 70, and patients with acute pancreatitis after ERCP are excluded. Blood viscosities at initial and 24 hours after hospitalization, and serum phosphate, which have shown potential as a predictor of severity in post-ERCP pancreatitis in previous studies are measured. The association of these blood biomarkers with the severity of acute pancreatitis will be analyzed and compared with hematocrit, C-reactive protein, etc., which are known as a single prognostic predictor of acute pancreatitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients between 19 and 70 years of age with acute pancreatitis, excluding post-ERCP pancreatitis.
Key inclusion criteria (2 listed)
- Age 19-70 years old
- Acute pancreatitis
Key exclusion criteria (1 listed)
- Post-Endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis
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
Prediction of severity of acute pancreatitis using initial blood viscosity
Time frame: 48hours after admission
Evaluate initial blood viscosity as a predictor of the severity of acute pancreatitis
2 secondary outcomes
Prediction of severity of acute pancreatitis using blood viscosity change after 24hours
Time frame: 24hours after admission
Prediction of severity of acute pancreatitis using serum phosphate
Time frame: 48hours after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Individual participant dataSharing planned: No
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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.
In Seok Lee, MD, PhD principal investigator
Seoul St. Mary's Hospital
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 In Seok Lee at 1 site in South Korea.
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 1 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 17 Sep 2020. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Young Hoon Choi, MD, MS (82-2-2258-6020, crzyzs@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of severity of acute pancreatitis using initial blood viscosity (time frame: 48hours after admission). 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 17 Sep 2020.