Clinical trial NCT03075592: Post-ERCP Pancreatitis Severity Indication (PEPSI) Study
Official title: Post-ERCP Pancreatitis Severity Indication (PEPSI) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatitis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 48
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 14 years of age and older, ERCP candidates.

Brief summary: This study plans to directly address the problem of post-ERCP pancreatitis to gauge the various factors involved in its development and genetic variability in the immune response to an isolated pancreatic insult. In addition, the investigators hope to study markers of the early immune response to this injury and to develop a risk-assessment model.

Detailed description: Endoscopic Retrograde Cholangiopancreaticography (ERCP) is an important diagnostic and therapeutic tool in the management of pancreatic and biliary diseases. However, it carries up to 10% risk of developing acute pancreatitis, 10% of which will be severe. Current models to predict the severity of acute pancreatitis are incomplete and unable to prognosticate early in the course of the disease because they are based on biomarkers of late immune response. Recent findings suggest that polymorphisms in the gene coding for MCP-1 (Monocyte Chemotactic Protein-1) play an important role in the early immune response leading to either mild versus severe acute pancreatitis of various etiologies.

This study plans to directly address the problem of post-ERCP pancreatitis to gauge the various factors involved in its development and genetic variability in the immune response to an isolated pancreatic insult. In addition, we hope to study markers of the early immune response to this injury and to develop a risk-assessment model.

Eligibility criteria: Inclusion Criteria:

1. All people presenting for ERCP procedures.
2. Males and females of 14 years of age and older.
3. Willingness to participate in the study and sign the informed consent. (Children will require a representative to sign the informed consent).
4. People in whom therapeutic pancreatic interventions are planned during the ERCP procedure.
5. Intact papilla

Exclusion Criteria:

1. Persons unwilling to sign the informed consent
2. Disorientation secondary to irreversible organic brain damage.
3. Hemoglobin of less than 11 gm/dl in children of 10 years of age to puberty and hemoglobin of 12 gm/dl in pubertal males and females.
4. Mean corpuscular volume (MCV) of less than 77 in all children of 18 years or younger.
5. ERCP scheduled for stent change
6. Previous diagnosis of pancreatic cancer or cholangiocarcinoma
7. History of chronic pancreatitis
8. Active Acute Pancreatitis prior to ERCP (typical pain and amylase or lipase \>3 times UNL)or smoldering pancreatitis
9. History of Recurrent Acute Pancreatitis with chronic pain between acute attacks of \>5/10 more than 3 days per week.
10. Previous sphincterotomy
11. Post surgical anatomy
12. History of organ transplant
13. On medications for the treatment of HIV

Primary outcomes:
measure: Number of patients who develop post ERCP pancreatitis as assessed by their clinical course
timeFrame: 1 year
Secondary outcomes:
measure: Number of patients with high serum amylase and cytokine levels as assessed by their clinical data.
timeFrame: 1 year
measure: Genetic markers that cause patients to develop post ERCP pancreatitis as identified by their genes
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University
name: Georgios I Papachristou, MD
role: STUDY_CHAIR
References: