Post-ERCP Pancreatitis Severity Indication (PEPSI) Study | NCT03075592

Studies
Post-ERCP Pancreatitis Severity Indication (PEPSI) Study

NCT03075592

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Dec 18, 2019Actual

Enrollment

48Actual

Phase

Not provided

Conditions

Pancreatitis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 22, 2009Actual

Primary Completion Date

Nov 22, 2019Actual

Completion Date

Nov 22, 2019Actual

First Submitted Date

Feb 2, 2017

First Submission Date that Met QC Criteria

Mar 8, 2017

First Posted Date

Mar 9, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2019

Last Update Posted Date

Dec 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

48Actual

Label	Type	Description	Intervention Names
ERCP candidates		ERCP candidates

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Number of patients with high serum amylase and cytokine levels as assessed by their clinical data.	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.	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients 14 years of age and older, ERCP candidates.

Sampling Method

Probability Sample

Name	Affiliation	Role
Georgios I Papachristou, MD	Ohio State University	Study Chair

ID	Term
D010195	Pancreatitis

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases

Description

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.