Acute Pancreatitis Targets (APT) Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Number of Participants with severe pancreatitis
Study Overview
Brief Summary
The severity of acute pancreatitis varies considerably from minor symptoms to multi-organ failure. The pathophysiological mechanisms associated with these individual differences in severity are largely unknown. Acute pancreatitis is therefore classified based on clinical characteristics and routine blood samples. Information about pathophysiology and molecular subtypes of acute pancreatitis is needed to develop specific biomarkers and identify new drug targets. The investigators therefore plan to undertake an explorative study, which includes state-of-the-art biochemical assessment of patients with acute pancreatitis including multi-OMICS focusing on transcriptomics and proteomics.
Detailed Description
Introduction Acute pancreatitis is a sudden inflammation of the pancreas with clinical manifestations ranging from a mild self-limiting disease to a severe form with necrosis of the pancreas and multi-organ dysfunction. Population-based cohort studies report a global incidence of 23 to 49 cases per 100,000 per year. In Denmark, more than 4,000 patients are admitted with acute pancreatitis each year. Gallstones and alcohol account for approximately 80% of all cases. Although the clinical characteristics and induction mechanism differ in the two groups, no differences in the inflammatory profile have been identified.
Acute pancreatitis is characterised by an early phase 7-10 days after the onset and a late phase after more than 10-14 days. The early phase is dominated by the host response to the local pancreatic injury leading to systemic inflammation. The late phase is characterized by infected pancreatic or peri-pancreatic necrosis, systemic signs of infection, and possible local complications including splanchnic vein thrombosis. Multi-organ dysfunction may occur in the early as well as the late phase. Although supportive treatment and minimally invasive techniques have improved the overall prognosis, the mortality among patients with severe pancreatitis remains about 10 to 15%. Once persistent multi-organ dysfunction develops, mortality is as high as 30 to 40%.
Following an episode of acute pancreatitis patients are in risk of developing comorbidities. Fifteen percent of the patients will develop diabetes within a year and 10 % will develop chronic pancreatitis after a first episode of acute pancreatitis.
At present time, there are no specific treaments to prevent attacks of acute pancreatitis, nor there are any disease modifying measures. Patients are mainly treated with supportive care which includes close monitoring of organ functions, pain management, fluid resuscitation and nutrition.
Several prognostics scores have been developed to identify patients at risk of developing severe acute pancreatitis. The scores are used in patient triage. Most scores include age and an assessment of the respiratory, circulatory and renal function. Blood glucose, platelets, albumin and calcium are used as markers of third space fluid losses, inflammation, lipolysis/fat necrosis and impaired pancreatic endocrine function. Other clinical variables include obesity, body mass index (BMI) and abdominal fat.
Study Design
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single group
- Primary Purpose
- Basic science
- Masking
- None (open label)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Adult patients (age >18 years) with acute pancreatitis according to the revised Atlanta criteria;12
- Informed consent;
- Known time of debut of symptoms.
Exclusion Criteria
- Chronic pancreatitis;
- Pregnancy;
- Known malignant disease;
- More than 72 hours from debut of symptoms to inclusion.
Arms & Interventions
Intensive monitoring of patients
State of the art biochemical assessment of patients with acute pancreatitis including multi-OMICS focusing on transcriptomics and proteomics.
Intervention: LiDCO (Other)
Outcomes
Primary Outcomes
Number of Participants with severe pancreatitis
Time Frame: 90 days
Development og severe pancreatitis according to standard definitions
Secondary Outcomes
No secondary outcomes reported
Investigators
John Gasdal Karstensen
Associate professor, MD, PhD
Copenhagen University Hospital, Hvidovre
Study Sites (1)
Identifiers
- NCT ID
- NCT04570852
- Other Study IDs
- APT
Dates
- First Submitted
- (6 years ago)
- First Posted
- (6 years ago)
- Primary Completion
- (4 years ago)
- Study Completion
- (3 years ago)
- Last Verified
- (2 years ago)
- Last updated
- (2 years ago)
Regulatory & Sharing
- FDA Regulated Drug
- No
- FDA Regulated Device
- No
- IPD Sharing Plan
- Yes
- Has Results
- No
