PancreatitisNCT03853447
Fibro-inflammatory Progression From Acute to Chronic Pancreatitis
An observational study of Pancreatitis and Acute Pancreatitis, run by Copenhagen University Hospital, Hvidovre at 3 sites in Denmark.
Trial summary
Observational prospective study evaluating the developement of chronic pancreatitis based on imaging modalities as well as biochemical markers of inflammation, fibrosis and oxidative stress. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatitis, Acute Pancreatitis, Recurrent Pancreatitis
- What is being tested?
- Diagnostic imaging
- How many people
- 150 participants
- Where
- 3 sitesDenmark
- Study dates
- 14 Feb 2019to 1 Jan 2041
- 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 70 years
- All sexes
- Adult, Older adult
Study population: Patients with CP, AC pr RAP who are not: 1. Pregnant or lactating patients 2. Contraindications to magnetic resonance imaging (MRI) or endoscopic ultrasound 3. Known chronic liver disease, chronic renal failure, malignancy, chronic inflammatory bowel syndrome, chronic obstructive lung disease, pulmonary fibrosis. 4. Treatment with anti-inflammatory drugs of any kind at the time of inclusion.
Who may be able to join
- Patients with CP (N=50) of any aetiology except gallstone induced CP: CP will be diagnosed based on MANNHEIM criteria .
- Cohort 2: Patients with their first attack of AP of any aetiology except gallstone induced AP (N=50). The revised Atlanta criteria for acute pancreatitis will be used as diagnostic criteria.
- Cohort 3: Patients with RAP (N=50) except gallstone induced RAP. RAP is defined as two or more cases of AP as diagnosed by the revised Atlanta Criteria.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Department of Gastroenterology & Hepatology, Aalborg University Hospital
Aalborg, 9000
Soeren Schou Olesen, PhD, +45 97 66 00 00, soso@dcm.aau.dk
- Recruiting
Abdominal Centre, Bispebjerg University Hospital
Copenhagen, 2200
Lars Nannestad Joergensen, PhD, +45 21 32 02 41, lars.nannestad.joergensen@regionh.dk
- Recruiting
Gastrounit, Copenhagen University Hospital Hvidovre
Hvidovre, Capital Region Denmark, 2650
Lise L Gluud, MD, +4538621964, lise.lotte.gluud.01@regionh.dk
Srdan Novovic, MD, +38623862, srdan.novovic@regionh.dk
About this study
Official title: Characterization of Fibro-inflammation During Progression From Acute to Chronic Pancreatitis
Observational prospective study evaluating the developement of chronic pancreatitis based on imaging modalities as well as biochemical markers of inflammation, fibrosis and oxidative stress.
Read the detailed description
Chronic pancreatitis (CP) represents the end-stage of a continuous disease process evolving from acute pancreatitis (AP), over recurrent acute pancreatitis (RAP). Due to the irreversible nature of CP, early detection and prevention is key. The study uses state-of-the-art imaging modalities as well as biochemical markers of to evaluate fibrosis progression in patients with pancreatitis.
The included participants have either first time AP, RAP, early CP with preserved pancreatic exocrine and endocrine function or end-stage CP with exocrine insufficiency. Included patients will be followed prospectively for 15 years with advanced MRI and contrast enhanced EUS with elastography, assessment of endocrine and exocrine pancreatic function, biochemical and nutritional assessment, and evaluation of pain processing using quantitative sensory testing. Blood for a biobank will be obtained. The purpose of the biobank is to allow analyses of potential biomarkers for the progression of disease eventually leading to CP.
- Conditions
- Pancreatitis, Acute Pancreatitis, Recurrent Pancreatitis, Chronic Pancreatitis, Inflammation, Fibrosis
- Being tested
- Diagnostic imaging
- Medical subject headings
- Pancreatitis, Pancreatitis, Chronic, Inflammation, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic imagingDiagnostic test
Also called MRI and EUS
MRI assessments including magnetic resonance cholangiopancreatography (MRCP) and diffusion weighted imaging (DWI) combined with gold standard EUS
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic imaging | The progression of fibrosis will be assessed based on diagnostic imaging of thre subgroups including
Patients with chronic pancreatitis (CP; N=50) of any aetiology, except gallstones, based on MANNHEIM.
Patients with their first attack of acute pancreatitis (AP; N=50) of any aetiology except gallstones using the revised Atlanta criteria for AP.
Patients with recurrent AP (RAP; N=50) except gallstones, defined as two or more cases of AP as diagnosed by the revised Atlanta Criteria. Receives: Diagnostic Test: Diagnostic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrosis progression on endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI)
Progression of fibrosis in the pancreas based on either EUS or MRI
Measured: 15 years
Secondary outcomes (1)
Lean body mass assessed using bioimpedance
Body composition focusing on lean body mass will be assessed using bioimpedance
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start14 Feb 2019
- Primary completion1 Jan 2040 (estimated)
- Study completion1 Jan 2041 (estimated)
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.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lise Gluud, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853447
- Sponsor's protocol ID
- H-18017281
- Status last verified
- Apr 2020
- First submitted
- 14 Feb 2019
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- 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 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Fibro-inflammation During Progression From Acute to Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT03853447
- Acronym / sponsor ID
- H-18017281
- Conditions
- Pancreatitis, Acute Pancreatitis, Recurrent Pancreatitis, Chronic Pancreatitis, Inflammation, Fibrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 1 Jan 2040 (estimated)
- Study completion
- 1 Jan 2041 (estimated)
- First posted
- 25 Feb 2019 (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.
Observational prospective study evaluating the developement of chronic pancreatitis based on imaging modalities as well as biochemical markers of inflammation, fibrosis and oxidative stress.
Detailed description
Chronic pancreatitis (CP) represents the end-stage of a continuous disease process evolving from acute pancreatitis (AP), over recurrent acute pancreatitis (RAP). Due to the irreversible nature of CP, early detection and prevention is key. The study uses state-of-the-art imaging modalities as well as biochemical markers of to evaluate fibrosis progression in patients with pancreatitis.
The included participants have either first time AP, RAP, early CP with preserved pancreatic exocrine and endocrine function or end-stage CP with exocrine insufficiency. Included patients will be followed prospectively for 15 years with advanced MRI and contrast enhanced EUS with elastography, assessment of endocrine and exocrine pancreatic function, biochemical and nutritional assessment, and evaluation of pain processing using quantitative sensory testing. Blood for a biobank will be obtained. The purpose of the biobank is to allow analyses of potential biomarkers for the progression of disease eventually leading to CP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic imaging | – | Diagnostic Test: Diagnostic imagingThe progression of fibrosis will be assessed based on diagnostic imaging of thre subgroups including Patients with chronic pancreatitis (CP; N=50) of any aetiology, except gallstones, based on MANNHEIM. Patients with their first attack of acute pancreatitis (AP; N=50) of any aetiology except gallstones using the revised Atlanta criteria for AP. Patients with recurrent AP (RAP; N=50) except gallstones, defined as two or more cases of AP as diagnosed by the revised Atlanta Criteria. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with CP, AC pr RAP who are not: 1. Pregnant or lactating patients 2. Contraindications to magnetic resonance imaging (MRI) or endoscopic ultrasound 3. Known chronic liver disease, chronic renal failure, malignancy, chronic inflammatory bowel syndrome, chronic obstructive lung disease, pulmonary fibrosis. 4. Treatment with anti-inflammatory drugs of any kind at the time of inclusion.
Key inclusion criteria (3 listed)
- Patients with CP (N=50) of any aetiology except gallstone induced CP: CP will be diagnosed based on MANNHEIM criteria .
- Cohort 2: Patients with their first attack of AP of any aetiology except gallstone induced AP (N=50). The revised Atlanta criteria for acute pancreatitis will be used as diagnostic criteria.
- Cohort 3: Patients with RAP (N=50) except gallstone induced RAP. RAP is defined as two or more cases of AP as diagnosed by the revised Atlanta Criteria.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Diagnostic imagingAlso: MRI and EUSMRI assessments including magnetic resonance cholangiopancreatography (MRCP) and diffusion weighted imaging (DWI) combined with gold standard EUS | Diagnostic test | Diagnostic imaging |
Primary outcome
Fibrosis progression on endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI)
Time frame: 15 years
Progression of fibrosis in the pancreas based on either EUS or MRI
1 secondary outcome
Lean body mass assessed using bioimpedance
Time frame: 15 years
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 8 Apr 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.
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 Pancreatitis and Acute Pancreatitis, run by Copenhagen University Hospital, Hvidovre at 3 sites in Denmark.
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 3 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 8 Apr 2020. 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 Denmark. 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?
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 Srdan Novovic, PhD (38623862, srdan.novovic@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibrosis progression on endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI) (time frame: 15 years). 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 8 Apr 2020.