Post-ERCP Pancreatitis Severity Indication (PEPSI) Study

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.

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Key information

Conditions

Pancreatitis Digestive System Diseases Pancreatic Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Number of patients who develop post ERCP pancreatitis as assessed by their clinical course

Time frame: 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 outcomes

Number of patients with high serum amylase and cytokine levels as assessed by their clinical data.

Time frame: 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.
Genetic markers that cause patients to develop post ERCP pancreatitis as identified by their genes

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Acronym: PEPSI

Important dates

Study start: 2009
Primary completion: 2019
Study completion: 2019
First posted: Mar 9, 2017
Registry last updated: Dec 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed