Chronic PancreatitisNCT04670705
Relationship of CP and AP
An observational study of Chronic Pancreatitis and Acute Pancreatitis, run by Changhai Hospital.
Trial summary
The present study aimed to determine the prevalence of AP attacks before the diagnosis of CP and further identified the potential associated factors for AP episodes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pancreatitis, Acute Pancreatitis
- What is being tested?
- patients' characteristics
- How many people
- 1,022 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Oct 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consequent patients with a diagnosis of CP were enrolled between January 2010 to December 2015 after informed consents obtained.The diagnosis of CP was established based on the findings of computed tomography, magnetic resonance imaging, or endoscopic ultrasound, in accordance with the Asia-Pacific consensus.
Who may be able to join
- Consequent patients with a diagnosis of CP between January 2010 to December 2015
- informed consents provided
Who cannot join
- autoimmune pancreatitis (AIP)
- pancreatic cancer diagnosed within 2 years after the diagnosis of CP
About this study
Official title: The Prevalence of Acute Pancreatitis Episodes Among Patients With Chronic Pancreatitis and the Associated Factors
The present study aimed to determine the prevalence of AP attacks before the diagnosis of CP and further identified the potential associated factors for AP episodes.
- Conditions
- Chronic Pancreatitis, Acute Pancreatitis
- Being tested
- patients' characteristics
- Medical subject headings
- Pancreatitis, Chronic, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients' characteristicsOther
There was no intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
the occurrence of acute pancreatitis
the presence and frequency of acute pancreatitis before diagnosis of CP
Measured: Baseline (before the diagnosis of CP)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study startJan 2010
- Primary completionDec 2015
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Cross-sectional
- Enrolment
- 1,022 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670705
- Sponsor's protocol ID
- AP&CP
- Status last verified
- Dec 2020
- First submitted
- 11 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Acute Pancreatitis Episodes Among Patients With Chronic Pancreatitis and the Associated Factors
- ClinicalTrials.gov ID
- NCT04670705
- Acronym / sponsor ID
- AP&CP
- Conditions
- Chronic Pancreatitis, Acute Pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,022 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 17 Dec 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.
The present study aimed to determine the prevalence of AP attacks before the diagnosis of CP and further identified the potential associated factors for AP episodes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consequent patients with a diagnosis of CP were enrolled between January 2010 to December 2015 after informed consents obtained.The diagnosis of CP was established based on the findings of computed tomography, magnetic resonance imaging, or endoscopic ultrasound, in accordance with the Asia-Pacific consensus.
Key inclusion criteria (2 listed)
- Consequent patients with a diagnosis of CP between January 2010 to December 2015
- informed consents provided
Key exclusion criteria (2 listed)
- autoimmune pancreatitis (AIP)
- pancreatic cancer diagnosed within 2 years after the diagnosis of CP
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 |
|---|---|---|
| patients' characteristicsThere was no intervention. | Other | – |
Primary outcome
the occurrence of acute pancreatitis
Time frame: Baseline (before the diagnosis of CP)
the presence and frequency of acute pancreatitis before diagnosis of CP
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 17 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis and Acute Pancreatitis, run by Changhai Hospital.
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: finished, as of the sponsor's last update on 17 Dec 2020. 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?
the occurrence of acute pancreatitis (time frame: Baseline (before the diagnosis of CP)). 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 Dec 2020.