Acute PancreatitisPAPPEINCT03063398
Post Acute Pancreatitis Pancreatic Exocrine Insufficiency
An observational study of Acute Pancreatitis, run by Ohio State University at 3 sites in United States.
Trial summary
This study is a proposed a comprehensive prospective assessment of exocrine pancreatic insufficiency (EPI), nutritional status, and quality of life (QOL) during the early re-feeding phase, at 3 months, and 12 months following an AP attack. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- How many people
- 196 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Jun 2017to 30 Jun 2024
- 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: Men and women, at least 18 years of age, admitted at the University of Pittsburgh Medical Center with an AP attack defined as the presence of 2 or more of the following criteria: * Abdominal pain consistent with the disease, * Serum amylase and/or lipase greater than three times the upper limit of normal, and or * Characteristic findings from abdominal imaging (i.e. demonstrating pancreatic edema, peripancreatic fat stranding or complications or acute pancreatitis)
Who may be able to join
- Men and women, at least 18 years of age, admitted at the University of Pittsburgh Medical Center with an AP attack defined as the presence of 2 or more of the following criteria:
- Abdominal pain consistent with the disease,
- Serum amylase and/or lipase greater than three times the upper limit of normal, and or
- Characteristic findings from abdominal imaging (i.e. demonstrating pancreatic edema, peripancreatic fat stranding or complications or acute pancreatitis)
Who cannot join
- Known or newly diagnosed chronic pancreatitis based on cross sectional imaging findings
- Pre-existing exocrine pancreatic insufficiency (meaning EPI present before the onset of AP; development of EPI during early refeeding is not an exclusion criterion)
- History of gastric or pancreatic resection
- History of small bowel disease (celiac disease, or Crohn's disease)
- History of pancreatic malignancy
- History of gastroparesis
- History of cystic fibrosis
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21225
The Ohio State University
Columbus, Ohio, 43210
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
About this study
Official title: PAPPEI: Post Acute Pancreatitis Pancreatic Exocrine Insufficiency
This study is a proposed a comprehensive prospective assessment of exocrine pancreatic insufficiency (EPI), nutritional status, and quality of life (QOL) during the early re-feeding phase, at 3 months, and 12 months following an AP attack.
Read the detailed description
This study is a proposed a comprehensive prospective assessment of exocrine pancreatic insufficiency (EPI), nutritional status, and quality of life (QOL) during the early re-feeding phase, at 3 months, and 12 months following an AP attack. A blood sample will be collected for measurement of nutritional markers and a fecal sample for elastase-1, and data regarding demographics, etiology, history of previous pancreatitis episodes, and their hospital course (imaging findings, interventions, length of stay, intensive care admission, and severity based on the Revised Atlanta Classification) will be obtained from medical records at hospital discharge. Subsequently, each subject will be prospectively followed at 3 months and 1 year after hospital discharge. In each follow-up, he/she will be asked to answer a questionnaire focusing on symptoms of exocrine pancreatic insufficiency and quality of life. Furthermore, blood and stool samples will be collected at the 3 and 12-month follow up for measurement of nutritional markers and fecal elastase-1 levels.
Based on available literature and our own data, we hypothesize that a significant fraction of AP patients develop EPI that may persist up to 1 year after the discharge, and result in nutritional deficiencies and impaired QOL. This study will help to clarify the incidence, natural history and duration of EPI, as well as identify subgroups of patients at high risk of EPI after AP. It will serve as the basis for the design of future randomized controlled trials of pancreatic enzyme replacement following AP. This is a novel proposal by an investigator with extensive experience and a well-established record in AP research from an internationally known pancreas center of excellence. The methodological strength of our proposal lies on its prospective nature, the 1-year follow up with serial assessments of EPI, nutritional status and QOL, and the detailed phenotypical characterization of the AP patient cohort.
Primary endpoints
- Measure the incidence of exocrine pancreatic insufficiency at 12 months after an attack of AP.
Secondary endpoints
- Identify subgroups of patients at risk for EPI at 12 months after an attack of AP based on severity classification, etiology, and demographics.
- Measure the incidence of transient (present at 3 but no at 12 months) and persistent (present both at 3 and 12 months after AP) exocrine pancreatic insufficiency following an AP attack.
- Measure the incidence of nutritional deficiencies, and impaired quality of life at 3 and 12 months from an attack of AP.
- Assess whether EPI is associated with nutritional deficiencies or impaired quality of life at 3 and 12 months from an AP attack.
- Conditions
- Acute Pancreatitis
- Being tested
- No intervention, this is an observational study
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, this is an observational studyDiagnostic test
Assessment for exocrine pancreatic insufficiency
| Study group | Role | What they receive |
|---|---|---|
| Patients after acute pancreatitis | Such patients will be followed and assessed for the development of Exocrine Pancreatic Insufficiency. 'No intervention, this is an observational study. Receives: Diagnostic Test: No intervention, this is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exocrine pancreatic insufficiency at 12 months
Fecal elastase-1 levels EPI below 200 mcg/g stool,
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start21 Jun 2017
- Primary completion1 Feb 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Principal investigator, George Papachristou, Ohio State University
- Investigators
- Georgios I Papachristou, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063398
- Sponsor's protocol ID
- STUDY19080096
- Acronym
- PAPPEI
- Status last verified
- Jul 2024
- First submitted
- 2 Feb 2017
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: In the future, the data may be shared with other entities. If so, the research data/documents will be coded and subject identifiers removed prior to access by the external persons.
Publications
Bejjani J, Culp S, Nikahd M, Phillips AE, Singh V, Roberts KM, Abu-El-Haija M, Krishna SG, Ramsey ML, Lahooti A, Lee PJ, Hart PA, Papachristou GI. Symptom Burden After Acute Pancreatitis and Its Correlation With Exocrine Pancreatic Function: A Multicenter Prospective Study. Clin Transl Gastroenterol. 2025 Feb 1;16(2):e00799. doi: 10.14309/ctg.0000000000000799.
PubMed 39679584Phillips AE, Bejjani J, Culp S, Chennat J, Lee PJ, Machicado JD, Singh VK, Afghani E, Ramsey ML, Paragomi P, Stello K, Nikahd M, Hart PA, Papachristou GI. Prevalence of exocrine pancreatic insufficiency at 12 months after acute pancreatitis: a prospective, multicentre, longitudinal cohort study. EClinicalMedicine. 2024 Aug 2;75:102774. doi: 10.1016/j.eclinm.2024.102774. eCollection 2024 Sep.
PubMed 39210941Bejjani J, Papachristou GI, Dungan K, Evans Phillips A, Singh V, Toledo FG, Han S, Krishna SG, Lahooti A, Lee PJ, Machicado JD, Nikahd M, Paragomi P, Ramsey M, Yadav D, Culp S, Hart PA. Incident diabetes following acute pancreatitis in a multicenter prospective observational cohort. Pancreatology. 2023 Dec;23(8):900-903. doi: 10.1016/j.pan.2023.10.009. Epub 2023 Oct 10.
PubMed 37839923Paragomi P, Phillips AE, Machicado JD, Lahooti A, Kamal A, Afghani E, Pothoulakis I, Reynolds SL, Mays M, Conwell DL, Lara LF, Singh VK, Papachristou GI. Post-Acute Pancreatitis Pancreatic Exocrine Insufficiency: Rationale and Methodology of a Prospective, Observational, Multicenter Cohort Study. Pancreas. 2021 Feb 1;50(2):147-152. doi: 10.1097/MPA.0000000000001743.
PubMed 33565790
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAPPEI: Post Acute Pancreatitis Pancreatic Exocrine Insufficiency
- ClinicalTrials.gov ID
- NCT03063398
- Acronym / sponsor ID
- PAPPEI / STUDY19080096
- Conditions
- Acute Pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 24 Feb 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 is a proposed a comprehensive prospective assessment of exocrine pancreatic insufficiency (EPI), nutritional status, and quality of life (QOL) during the early re-feeding phase, at 3 months, and 12 months following an AP attack.
Detailed description
This study is a proposed a comprehensive prospective assessment of exocrine pancreatic insufficiency (EPI), nutritional status, and quality of life (QOL) during the early re-feeding phase, at 3 months, and 12 months following an AP attack. A blood sample will be collected for measurement of nutritional markers and a fecal sample for elastase-1, and data regarding demographics, etiology, history of previous pancreatitis episodes, and their hospital course (imaging findings, interventions, length of stay, intensive care admission, and severity based on the Revised Atlanta Classification) will be obtained from medical records at hospital discharge. Subsequently, each subject will be prospectively followed at 3 months and 1 year after hospital discharge. In each follow-up, he/she will be asked to answer a questionnaire focusing on symptoms of exocrine pancreatic insufficiency and quality of life. Furthermore, blood and stool samples will be collected at the 3 and 12-month follow up for measurement of nutritional markers and fecal elastase-1 levels.
Based on available literature and our own data, we hypothesize that a significant fraction of AP patients develop EPI that may persist up to 1 year after the discharge, and result in nutritional deficiencies and impaired QOL. This study will help to clarify the incidence, natural history and duration of EPI, as well as identify subgroups of patients at high risk of EPI after AP. It will serve as the basis for the design of future randomized controlled trials of pancreatic enzyme replacement following AP. This is a novel proposal by an investigator with extensive experience and a well-established record in AP research from an internationally known pancreas center of excellence. The methodological strength of our proposal lies on its prospective nature, the 1-year follow up with serial assessments of EPI, nutritional status and QOL, and the detailed phenotypical characterization of the AP patient cohort.
Primary endpoints
- Measure the incidence of exocrine pancreatic insufficiency at 12 months after an attack of AP.
Secondary endpoints
- Identify subgroups of patients at risk for EPI at 12 months after an attack of AP based on severity classification, etiology, and demographics.
- Measure the incidence of transient (present at 3 but no at 12 months) and persistent (present both at 3 and 12 months after AP) exocrine pancreatic insufficiency following an AP attack.
- Measure the incidence of nutritional deficiencies, and impaired quality of life at 3 and 12 months from an attack of AP.
- Assess whether EPI is associated with nutritional deficiencies or impaired quality of life at 3 and 12 months from an AP attack.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients after acute pancreatitis | – | Diagnostic Test: No intervention, this is an observational studySuch patients will be followed and assessed for the development of Exocrine Pancreatic Insufficiency. 'No intervention, this is an observational study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women, at least 18 years of age, admitted at the University of Pittsburgh Medical Center with an AP attack defined as the presence of 2 or more of the following criteria: * Abdominal pain consistent with the disease, * Serum amylase and/or lipase greater than three times the upper limit of normal, and or * Characteristic findings from abdominal imaging (i.e. demonstrating pancreatic edema, peripancreatic fat stranding or complications or acute pancreatitis)
Key inclusion criteria (4 listed)
- Men and women, at least 18 years of age, admitted at the University of Pittsburgh Medical Center with an AP attack defined as the presence of 2 or more of the following criteria:
Key exclusion criteria (7 listed)
- Known or newly diagnosed chronic pancreatitis based on cross sectional imaging findings
- Pre-existing exocrine pancreatic insufficiency (meaning EPI present before the onset of AP; development of EPI during early refeeding is not an exclusion criterion)
- History of gastric or pancreatic resection
- History of small bowel disease (celiac disease, or Crohn's disease)
- History of pancreatic malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, this is an observational studyAssessment for exocrine pancreatic insufficiency | Diagnostic test | Patients after acute pancreatitis |
Primary outcome
Exocrine pancreatic insufficiency at 12 months
Time frame: 12 months
Fecal elastase-1 levels EPI below 200 mcg/g stool,
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 16 Jul 2024.
- Derived from this study: PubMed 39679584Bejjani J, Culp S, Nikahd M, Phillips AE, Singh V, Roberts KM, Abu-El-Haija M, Krishna SG, Ramsey ML, Lahooti A, Lee PJ, Hart PA, Papachristou GI. Symptom Burden After Acute Pancreatitis and Its Correlation With Exocrine Pancreatic Function: A Multicenter Prospective Study. Clin Transl Gastroenterol. 2025 Feb 1;16(2):e00799. doi: 10.14309/ctg.0000000000000799.
- Derived from this study: PubMed 39210941Phillips AE, Bejjani J, Culp S, Chennat J, Lee PJ, Machicado JD, Singh VK, Afghani E, Ramsey ML, Paragomi P, Stello K, Nikahd M, Hart PA, Papachristou GI. Prevalence of exocrine pancreatic insufficiency at 12 months after acute pancreatitis: a prospective, multicentre, longitudinal cohort study. EClinicalMedicine. 2024 Aug 2;75:102774. doi: 10.1016/j.eclinm.2024.102774. eCollection 2024 Sep.
- Derived from this study: PubMed 37839923Bejjani J, Papachristou GI, Dungan K, Evans Phillips A, Singh V, Toledo FG, Han S, Krishna SG, Lahooti A, Lee PJ, Machicado JD, Nikahd M, Paragomi P, Ramsey M, Yadav D, Culp S, Hart PA. Incident diabetes following acute pancreatitis in a multicenter prospective observational cohort. Pancreatology. 2023 Dec;23(8):900-903. doi: 10.1016/j.pan.2023.10.009. Epub 2023 Oct 10.
- Derived from this study: PubMed 33565790Paragomi P, Phillips AE, Machicado JD, Lahooti A, Kamal A, Afghani E, Pothoulakis I, Reynolds SL, Mays M, Conwell DL, Lara LF, Singh VK, Papachristou GI. Post-Acute Pancreatitis Pancreatic Exocrine Insufficiency: Rationale and Methodology of a Prospective, Observational, Multicenter Cohort Study. Pancreas. 2021 Feb 1;50(2):147-152. doi: 10.1097/MPA.0000000000001743.
- Individual participant dataSharing planned: Undecided. In the future, the data may be shared with other entities. If so, the research data/documents will be coded and subject identifiers removed prior to access by the external persons.
Related trials for Acute Pancreatitis
Recruiting
Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis
Pancreatitis, Acute
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
Not yet recruiting
Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Post ERCP Pancreatitis, Acute Pancreatitis (AP)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
RecruitingPhase 1/2
Soy Tomato Juice to Improve Outcomes in Pancreatitis
Recurrent Acute Pancreatitis, Chronic Pancreatitis
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 principal investigator
Ohio State University
3 sites 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 Ohio State University at 3 sites in United States.
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 7 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 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
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?
Exocrine pancreatic insufficiency at 12 months (time frame: 12 months). 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 NCT03063398, which also lists 4 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 16 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.