Post-ERCP Pancreatitis Severity Indication (PEPSI) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-22

Study Completion Date

2019-11-22

Brief Summary

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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

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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.

Conditions

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Pancreatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ERCP candidates

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Georgios Papachristou

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georgios I Papachristou, MD

Role: STUDY_CHAIR

Ohio State University

Countries

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United States

Other Identifiers

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IRB0609028

Identifier Type: -

Identifier Source: org_study_id