Pancreatitis, AcuteACCESS-APNCT04743323
A Case-CrossovEr Study deSign to Inform Tailored Interventions to Prevent Disease Progression in Acute Pancreatitis
An observational study of Pancreatitis, Acute and Alcohol Drinking, run by Cedars-Sinai Medical Center at 5 sites in United States.
Trial summary
The Purpose of this study is to investigate changes in alcohol consumption in the period leading up to the onset of pancreatitis and compare that to levels of drinking during asymptomatic periods. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatitis, Acute, Alcohol Drinking, Health Behavior
- How many people
- 160 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jun 2020to 1 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults that consume alcohol who are hospitalized for acute pancreatitis.
Who may be able to join
- Aged 18-75 years at the time of eligibility assessment
- Currently hospitalized with Acute Pancreatitis (AP) per Revised Atlanta Classification, which requires two of the following evidence of pancreatitis:
- Abdominal pain consistent with AP (acute onset of a persistent, severe, epigastric pain often radiating to the back)
- Serum lipase activity (or amylase activity) at least three times greater than the upper limit of normal
- Characteristic findings of AP on computed tomography (CT), magnetic resonance imaging (MRI) or transabdominal ultrasonography
- Alcohol Use Disorders Identification Test Consumption (AUDIT-C) alcohol consumption score of ≥3
Who cannot join
- Pancreatitis presumed to be related to: gallstones, medication, trauma, autoimmune pancreatitis, post-ERCP pancreatitis, pancreatic ductal adenocarcinoma, suspected cystic neoplasm, neuroendocrine tumors, and other uncommon tumors.
- Chronic pancreatitis with calcification(s).
- Pancreatic cancer or pancreatic metastasis from other malignancies.
- History of pancreas transplant or pancreatectomy
- Current medical or psychiatric illnesses that in the investigator's opinion would compromise their ability to tolerate study procedures or participate in longitudinal follow up.
- Currently incarcerated.
- Known current pregnancy.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Ohio State University
Columbus, Ohio, 43210
University of Southern California
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90034
Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California, 90034
University of Pittsburg
Pittsburgh, Pennsylvania, 15260
About this study
Official title: A Case-CrossovEr Study deSign to Inform Tailored Interventions to Prevent Disease
The Purpose of this study is to investigate changes in alcohol consumption in the period leading up to the onset of pancreatitis and compare that to levels of drinking during asymptomatic periods.
Read the detailed description
There is no question that long-term heavy consumption of alcohol leads to increased risk of recurrent acute and chronic pancreatitis. While many patients and providers assume that heavy episodic alcohol consumption leads to acute pancreatitis, it is yet unknown whether 'binge' drinking truly causes pancreatitis and if so, what the relevant timing and duration of hazardous alcohol consumption is. Because of the lack of clarity on the transient effects of alcohol on acute pancreatitis, patients and providers are left with an uncertain disease progression and lack of tailored alcohol reduction recommendations.
Our study aims to investigate changes in alcohol consumption in the period leading up to the onset of pancreatitis and compare that to levels of drinking during asymptomatic periods. This epidemiologic design is called the case-crossover study, in which the diseased person serves as his/her own control. This study design has advantages over typical case-control studies in that factors that do not change within the individual, such as sex, race, genetic risks, will not interfere with evaluating the causal role of heavy episodic drinking on pancreatitis.
Participants in this study will undergo detailed interview on recent and lifetime alcohol consumption and other correlated health behaviors while they are hospitalized. Blood and urine will be collected during the hospitalization. After discharge, they will be interviewed again for any changes in alcohol consumption and blood and urine will be collected during a standard of care visit. The investigators will chart the progression of their disease through quarterly check-up by phone and through the medical records.
Ultimately, the investigators aim to generate data that will empower patients and providers to develop tailored regimens for prevention of recurrent acute pancreatitis, that will have lasting beneficial effects in averting irreversible damage to the pancreas.
- Conditions
- Pancreatitis, Acute, Alcohol Drinking, Health Behavior
- Medical subject headings
- Pancreatitis, Alcohol Drinking, Health Behavior
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 |
|---|---|---|
| Study Participants | Participants will be recruited whilst hospitalized for an acute episode of pancreatitis. They will be interviewed about their health behaviors including alcohol consumption during the two weeks immediately preceding the onset of pancreatitis. Blood and urine bio-specimens will be collected at this time. Following discharge from hospital (5-26 weeks) the same participant will be interviewed again during an asymptomatic control period and blood and urine bio-specimens will be collected. This study will compare the participant's exposure immediately preceding the onset of pancreatitis to that of an asymptomatic control period from the same participant. Participants will be followed for 24 months via review of their medical records every 6 months to assess any recurrent disease or progression of disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Consumption
Compare alcohol consumption prior to an attack of Acute Pancreatitis to that during an asymptomatic control period. Alcohol consumption will be measured by a 48-hour recall questionnaire, and timeline follow-back instrument.
Measured: Between 5-26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start1 Jun 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatitis, AcuteStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, University of Pittsburgh, Alcohol Research Group, Ohio State University, VA Greater Los Angeles Healthcare System
- Responsible party
- Principal investigator, Christie Jeon, Cedars-Sinai Medical Center
- Investigators
- Christie Y Jeon, ScD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743323
- Sponsor's protocol ID
- STUDY00000364
- Other IDs
- 7W81XWH1910888
- Acronym
- ACCESS-AP
- Status last verified
- Aug 2023
- First submitted
- 4 Feb 2021
- Last updated
- 31 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cherpitel CJ, Ye Y, Bond J, Borges G, Macdonald S, Stockwell T, Room R, Sovinova H, Marais S, Giesbrecht N. Validity of self-reported drinking before injury compared with a physiological measure: cross-national analysis of emergency-department data from 16 countries. J Stud Alcohol Drugs. 2007 Mar;68(2):296-302. doi: 10.15288/jsad.2007.68.296.
PubMed 17286349Jeon CY, Papachristou GI, Pisegna JR, Pendergast FJ, Lin YC, Cherpitel CJ, Ye Y, Pandol SJ, Yadav D. A Case-CrossovEr study deSign to inform tailored interventions to prevent disease progression in Acute Pancreatitis (ACCESS-AP) - study design and population. Pancreatology. 2021 Oct;21(7):1231-1236. doi: 10.1016/j.pan.2021.06.007. Epub 2021 Jun 24.
PubMed 34229971Jeon CY, Adeniran E, Stewart C, Papachristou GI, Pisegna JR, Kuc AA, Buxbaum JL, Pandol SJ, Yadav D. Female patients delay seeking medical care with alcohol-associated acute pancreatitis. Pancreatology. 2023 Nov;23(7):761-766. doi: 10.1016/j.pan.2023.08.001. Epub 2023 Aug 5.
PubMed 37567847
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-CrossovEr Study deSign to Inform Tailored Interventions to Prevent Disease
- ClinicalTrials.gov ID
- NCT04743323
- Acronym / sponsor ID
- ACCESS-AP / STUDY00000364
- Conditions
- Pancreatitis, Acute, Alcohol Drinking, Health Behavior
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense, University of Pittsburgh, Alcohol Research Group, Ohio State University, VA Greater Los Angeles Healthcare System
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 8 Feb 2021 (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 Purpose of this study is to investigate changes in alcohol consumption in the period leading up to the onset of pancreatitis and compare that to levels of drinking during asymptomatic periods.
Detailed description
There is no question that long-term heavy consumption of alcohol leads to increased risk of recurrent acute and chronic pancreatitis. While many patients and providers assume that heavy episodic alcohol consumption leads to acute pancreatitis, it is yet unknown whether 'binge' drinking truly causes pancreatitis and if so, what the relevant timing and duration of hazardous alcohol consumption is. Because of the lack of clarity on the transient effects of alcohol on acute pancreatitis, patients and providers are left with an uncertain disease progression and lack of tailored alcohol reduction recommendations.
Our study aims to investigate changes in alcohol consumption in the period leading up to the onset of pancreatitis and compare that to levels of drinking during asymptomatic periods. This epidemiologic design is called the case-crossover study, in which the diseased person serves as his/her own control. This study design has advantages over typical case-control studies in that factors that do not change within the individual, such as sex, race, genetic risks, will not interfere with evaluating the causal role of heavy episodic drinking on pancreatitis.
Participants in this study will undergo detailed interview on recent and lifetime alcohol consumption and other correlated health behaviors while they are hospitalized. Blood and urine will be collected during the hospitalization. After discharge, they will be interviewed again for any changes in alcohol consumption and blood and urine will be collected during a standard of care visit. The investigators will chart the progression of their disease through quarterly check-up by phone and through the medical records.
Ultimately, the investigators aim to generate data that will empower patients and providers to develop tailored regimens for prevention of recurrent acute pancreatitis, that will have lasting beneficial effects in averting irreversible damage to the pancreas.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Participants | – | –Participants will be recruited whilst hospitalized for an acute episode of pancreatitis. They will be interviewed about their health behaviors including alcohol consumption during the two weeks immediately preceding the onset of pancreatitis. Blood and urine bio-specimens will be collected at this time. Following discharge from hospital (5-26 weeks) the same participant will be interviewed again during an asymptomatic control period and blood and urine bio-specimens will be collected. This study will compare the participant's exposure immediately preceding the onset of pancreatitis to that of an asymptomatic control period from the same participant. Participants will be followed for 24 months via review of their medical records every 6 months to assess any recurrent disease or progression of disease. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults that consume alcohol who are hospitalized for acute pancreatitis.
Key inclusion criteria (6 listed)
- Aged 18-75 years at the time of eligibility assessment
- Currently hospitalized with Acute Pancreatitis (AP) per Revised Atlanta Classification, which requires two of the following evidence of pancreatitis:
- Alcohol Use Disorders Identification Test Consumption (AUDIT-C) alcohol consumption score of ≥3
Key exclusion criteria (7 listed)
- Pancreatitis presumed to be related to: gallstones, medication, trauma, autoimmune pancreatitis, post-ERCP pancreatitis, pancreatic ductal adenocarcinoma, suspected cystic neoplasm, neuroendocrine tumors, and other uncommon tumors.
- Chronic pancreatitis with calcification(s).
- Pancreatic cancer or pancreatic metastasis from other malignancies.
- History of pancreas transplant or pancreatectomy
- Current medical or psychiatric illnesses that in the investigator's opinion would compromise their ability to tolerate study procedures or participate in longitudinal follow up.
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
Alcohol Consumption
Time frame: Between 5-26 weeks
Compare alcohol consumption prior to an attack of Acute Pancreatitis to that during an asymptomatic control period. Alcohol consumption will be measured by a 48-hour recall questionnaire, and timeline follow-back instrument.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Background: PubMed 17286349Cherpitel CJ, Ye Y, Bond J, Borges G, Macdonald S, Stockwell T, Room R, Sovinova H, Marais S, Giesbrecht N. Validity of self-reported drinking before injury compared with a physiological measure: cross-national analysis of emergency-department data from 16 countries. J Stud Alcohol Drugs. 2007 Mar;68(2):296-302. doi: 10.15288/jsad.2007.68.296.
- Background: PubMed 34229971Jeon CY, Papachristou GI, Pisegna JR, Pendergast FJ, Lin YC, Cherpitel CJ, Ye Y, Pandol SJ, Yadav D. A Case-CrossovEr study deSign to inform tailored interventions to prevent disease progression in Acute Pancreatitis (ACCESS-AP) - study design and population. Pancreatology. 2021 Oct;21(7):1231-1236. doi: 10.1016/j.pan.2021.06.007. Epub 2021 Jun 24.
- Results publication: PubMed 37567847Jeon CY, Adeniran E, Stewart C, Papachristou GI, Pisegna JR, Kuc AA, Buxbaum JL, Pandol SJ, Yadav D. Female patients delay seeking medical care with alcohol-associated acute pancreatitis. Pancreatology. 2023 Nov;23(7):761-766. doi: 10.1016/j.pan.2023.08.001. Epub 2023 Aug 5.
- 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.
Christie Y Jeon, ScD principal investigator
Cedars-Sinai Medical Center
5 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, Acute and Alcohol Drinking, run by Cedars-Sinai Medical Center at 5 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 6 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: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Results are not available in the source record.
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?
Alcohol Consumption (time frame: Between 5-26 weeks). 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 NCT04743323, which also lists 3 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 31 Aug 2023.