Post-ERCP Pancreatitis Severity Indication (PEPSI) Study

NCT03075592 | Completed

• 1 other identifier: IRB0609028
• Study Type: observational
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatitis

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 year

Secondary Outcomes (2)

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

  1 year

• Genetic markers that cause patients to develop post ERCP pancreatitis as identified by their genes

  1 year

Study Arms (1)

ERCP candidates

ERCP candidates

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients 14 years of age and older, ERCP candidates.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Biospecimen

Retention: SAMPLES WITH DNA

Participant samples will be stored for an indefinite period of time in the Genomics and Proteomics Core Laboratories or in the laboratory of Dr. Whitcomb or appropriate core facility at the University of Pittsburgh. The samples will remain within the research studies of Dr. Whitcomb. Only authorized samples will be made available to other studies following IRB guidelines. The primary investigator, Dr. David Whitcomb, will have control over the blood samples.

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Georgios I Papachristou, MD

  Ohio State University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: March 9, 2017
• Study Start: April 22, 2009
• Primary Completion: November 22, 2019
• Study Completion: November 22, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12