Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-01-16 @ 1:34 AM
Study NCT ID:
NCT03075592
Status:
COMPLETED
Last Update Posted:
2019-12-18
First Post:
2017-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-ERCP Pancreatitis Severity Indication (PEPSI) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-14', 'studyFirstSubmitDate': '2017-02-02', 'studyFirstSubmitQcDate': '2017-03-08', 'lastUpdatePostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who develop post ERCP pancreatitis as assessed by their clinical course', 'timeFrame': '1 year', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Number of patients with high serum amylase and cytokine levels as assessed by their clinical data.', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'Genetic markers that cause patients to develop post ERCP pancreatitis as identified by their genes', 'timeFrame': '1 year', 'description': 'Determine if genetic polymorphisms of Monocyte Chemotactic Protein-1 (MCP-1) confer an increased risk for post-ERCP (Endoscopic Retrograde Cholangio- Pancreaticography) acute pancreatitis.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatitis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients 14 years of age and older, ERCP candidates.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All people presenting for ERCP procedures.\n2. Males and females of 14 years of age and older.\n3. Willingness to participate in the study and sign the informed consent. (Children will require a representative to sign the informed consent).\n4. People in whom therapeutic pancreatic interventions are planned during the ERCP procedure.\n5. Intact papilla\n\nExclusion Criteria:\n\n1. Persons unwilling to sign the informed consent\n2. Disorientation secondary to irreversible organic brain damage.\n3. 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.\n4. Mean corpuscular volume (MCV) of less than 77 in all children of 18 years or younger.\n5. ERCP scheduled for stent change\n6. Previous diagnosis of pancreatic cancer or cholangiocarcinoma\n7. History of chronic pancreatitis\n8. Active Acute Pancreatitis prior to ERCP (typical pain and amylase or lipase \\>3 times UNL)or smoldering pancreatitis\n9. History of Recurrent Acute Pancreatitis with chronic pain between acute attacks of \\>5/10 more than 3 days per week.\n10. Previous sphincterotomy\n11. Post surgical anatomy\n12. History of organ transplant\n13. On medications for the treatment of HIV'}, 'identificationModule': {'nctId': 'NCT03075592', 'acronym': 'PEPSI', 'briefTitle': 'Post-ERCP Pancreatitis Severity Indication (PEPSI) Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Post-ERCP Pancreatitis Severity Indication (PEPSI) Study', 'orgStudyIdInfo': {'id': 'IRB0609028'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ERCP candidates', 'description': 'ERCP candidates'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Georgios I Papachristou, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Georgios Papachristou', 'investigatorAffiliation': 'University of Pittsburgh'}}}}