PancreatitisPEPSINCT03075592
Post-ERCP Pancreatitis Severity Indication (PEPSI) Study
An observational study of Pancreatitis, run by University of Pittsburgh.
Trial summary
This study plans to directly address the problem of post-ERCP pancreatitis to gauge the various factors involved in its development and genetic variability in the immune response to an isolated pancreatic insult. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Pancreatitis
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 22 Apr 2009to 22 Nov 2019
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients 14 years of age and older, ERCP candidates.
Who may be able to join
- All people presenting for ERCP procedures.
- Males and females of 14 years of age and older.
- Willingness to participate in the study and sign the informed consent. (Children will require a representative to sign the informed consent).
- People in whom therapeutic pancreatic interventions are planned during the ERCP procedure.
- Intact papilla
Who cannot join
- Persons unwilling to sign the informed consent
- Disorientation secondary to irreversible organic brain damage.
- Hemoglobin of less than 11 gm/dl in children of 10 years of age to puberty and hemoglobin of 12 gm/dl in pubertal males and females.
- Mean corpuscular volume (MCV) of less than 77 in all children of 18 years or younger.
- ERCP scheduled for stent change
- Previous diagnosis of pancreatic cancer or cholangiocarcinoma
Show all 13Show fewer
- History of chronic pancreatitis
- Active Acute Pancreatitis prior to ERCP (typical pain and amylase or lipase >3 times UNL)or smoldering pancreatitis
- History of Recurrent Acute Pancreatitis with chronic pain between acute attacks of >5/10 more than 3 days per week.
- Previous sphincterotomy
- Post surgical anatomy
- History of organ transplant
- On medications for the treatment of HIV
About this study
This study plans to directly address the problem of post-ERCP pancreatitis to gauge the various factors involved in its development and genetic variability in the immune response to an isolated pancreatic insult. In addition, the investigators hope to study markers of the early immune response to this injury and to develop a risk-assessment model.
Read the detailed description
Endoscopic Retrograde Cholangiopancreaticography (ERCP) is an important diagnostic and therapeutic tool in the management of pancreatic and biliary diseases. However, it carries up to 10% risk of developing acute pancreatitis, 10% of which will be severe. Current models to predict the severity of acute pancreatitis are incomplete and unable to prognosticate early in the course of the disease because they are based on biomarkers of late immune response. Recent findings suggest that polymorphisms in the gene coding for MCP-1 (Monocyte Chemotactic Protein-1) play an important role in the early immune response leading to either mild versus severe acute pancreatitis of various etiologies.
This study plans to directly address the problem of post-ERCP pancreatitis to gauge the various factors involved in its development and genetic variability in the immune response to an isolated pancreatic insult. In addition, we hope to study markers of the early immune response to this injury and to develop a risk-assessment model.
- Conditions
- Pancreatitis
- 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 |
|---|---|---|
| ERCP candidates | ERCP candidates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who develop post ERCP pancreatitis as assessed by their clinical course
Develop a multi-factorial mathematical risk model that will help predict the exact risk for pancreatitis-associated complications of ERCP and to help power and structure future interventional studies.
Measured: 1 year
Secondary outcomes (2)
Number of patients with high serum amylase and cytokine levels as assessed by their clinical data.
Determine the relationship between pre and post-ERCP serum amylase and cytokine levels including IL-6, IL-8, CRP and MCP-1 and other injury or inflammatory markers as biomarkers of genetic polymorphisms in the corresponding genes.
Measured: 1 year
Genetic markers that cause patients to develop post ERCP pancreatitis as identified by their genes
Determine if genetic polymorphisms of Monocyte Chemotactic Protein-1 (MCP-1) confer an increased risk for post-ERCP (Endoscopic Retrograde Cholangio- Pancreaticography) acute pancreatitis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start22 Apr 2009
- Primary completion22 Nov 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Papachristou, University of Pittsburgh
- Investigators
- Georgios I Papachristou, MD, Study chair, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075592
- Sponsor's protocol ID
- IRB0609028
- Acronym
- PEPSI
- Status last verified
- Dec 2019
- First submitted
- 2 Feb 2017
- Last updated
- 18 Dec 2019
- 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 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-ERCP Pancreatitis Severity Indication (PEPSI) Study
- ClinicalTrials.gov ID
- NCT03075592
- Acronym / sponsor ID
- PEPSI / IRB0609028
- Conditions
- Pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 22 Apr 2009 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 9 Mar 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.
This study plans to directly address the problem of post-ERCP pancreatitis to gauge the various factors involved in its development and genetic variability in the immune response to an isolated pancreatic insult. In addition, the investigators hope to study markers of the early immune response to this injury and to develop a risk-assessment model.
Detailed description
Endoscopic Retrograde Cholangiopancreaticography (ERCP) is an important diagnostic and therapeutic tool in the management of pancreatic and biliary diseases. However, it carries up to 10% risk of developing acute pancreatitis, 10% of which will be severe. Current models to predict the severity of acute pancreatitis are incomplete and unable to prognosticate early in the course of the disease because they are based on biomarkers of late immune response. Recent findings suggest that polymorphisms in the gene coding for MCP-1 (Monocyte Chemotactic Protein-1) play an important role in the early immune response leading to either mild versus severe acute pancreatitis of various etiologies.
This study plans to directly address the problem of post-ERCP pancreatitis to gauge the various factors involved in its development and genetic variability in the immune response to an isolated pancreatic insult. In addition, we hope to study markers of the early immune response to this injury and to develop a risk-assessment model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERCP candidates | – | –ERCP candidates |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients 14 years of age and older, ERCP candidates.
Key inclusion criteria (5 listed)
- All people presenting for ERCP procedures.
- Males and females of 14 years of age and older.
- Willingness to participate in the study and sign the informed consent. (Children will require a representative to sign the informed consent).
- People in whom therapeutic pancreatic interventions are planned during the ERCP procedure.
- Intact papilla
Key exclusion criteria (13 listed)
- Persons unwilling to sign the informed consent
- Disorientation secondary to irreversible organic brain damage.
- Hemoglobin of less than 11 gm/dl in children of 10 years of age to puberty and hemoglobin of 12 gm/dl in pubertal males and females.
- Mean corpuscular volume (MCV) of less than 77 in all children of 18 years or younger.
- ERCP scheduled for stent change
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 patients who develop post ERCP pancreatitis as assessed by their clinical course
Time frame: 1 year
Develop a multi-factorial mathematical risk model that will help predict the exact risk for pancreatitis-associated complications of ERCP and to help power and structure future interventional studies.
2 secondary outcomes
Number of patients with high serum amylase and cytokine levels as assessed by their clinical data.
Time frame: 1 year
Genetic markers that cause patients to develop post ERCP pancreatitis as identified by their genes
Time frame: 1 year
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 18 Dec 2019.
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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.
Georgios I Papachristou, MD study chair
Ohio State University
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis, run by University of Pittsburgh.
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 5 inclusion and 13 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 18 Dec 2019. 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 patients who develop post ERCP pancreatitis as assessed by their clinical course (time frame: 1 year). 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 18 Dec 2019.