Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04743323
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-31
First Post:
2021-02-04
Brief Title:
A Case-CrossovEr Study deSign to Inform Tailored Interventions to Prevent Disease Progression in Acute Pancreatitis
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
A Case-CrossovEr Study deSign to Inform Tailored Interventions to Prevent Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACCESS-AP
Brief 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
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 hisher 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
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 hisher 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 7W81XWH1910888 | OTHER_GRANT | Department of Defense | None |