Post-ERCP Pancreatitis Severity Indication (PEPSI) Study

Completed

• Conditions: Pancreatitis

• Registration Number: NCT03075592
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study Start: 2009-04-22
• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-03-08
• Study First Posted: 2017-03-09
• Primary Completion: 2019-11-22
• Study Completion: 2019-11-22
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-14
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients who develop post ERCP pancreatitis as assessed by their clinical course	1 year	Develop a multi-factorial mathematical risk model that will help predict the exact risk for pancreatitis-associated complications of ERCP and to help power and structure future interventional studies.

Secondary Outcome Measures

Name	Time	Method
Genetic markers that cause patients to develop post ERCP pancreatitis as identified by their genes	1 year	Determine if genetic polymorphisms of Monocyte Chemotactic Protein-1 (MCP-1) confer an increased risk for post-ERCP (Endoscopic Retrograde Cholangio- Pancreaticography) acute pancreatitis.
Number of patients with high serum amylase and cytokine levels as assessed by their clinical data.	1 year	Determine the relationship between pre and post-ERCP serum amylase and cytokine levels including IL-6, IL-8, CRP and MCP-1 and other injury or inflammatory markers as biomarkers of genetic polymorphisms in the corresponding genes.