Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT06179459
Status:
RECRUITING
Last Update Posted:
2025-11-04
First Post:
2023-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D010192', 'term': 'Pancreatic Pseudocyst'}, {'id': 'D019283', 'term': 'Pancreatitis, Acute Necrotizing'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010181', 'term': 'Pancreatic Cyst'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2032-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-03', 'studyFirstSubmitDate': '2023-12-12', 'studyFirstSubmitQcDate': '2023-12-12', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections.', 'timeFrame': '3 years', 'description': 'Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections.'}], 'secondaryOutcomes': [{'measure': 'Treatment success', 'timeFrame': '6 months', 'description': 'Rate of treatment success, defined as the resolution of pancreatic fluid collection on CT scan in association with clinical resolution of symptoms at 6-months from index intervention.'}, {'measure': 'Number and type of interventions performed', 'timeFrame': '6 months', 'description': 'Number of interventions performed to achieve treatment success'}, {'measure': 'Need for surgical intervention', 'timeFrame': '6 months', 'description': 'Need for any surgical intervention in patients undergoing endoscopic therapy for pancreatic fluid collections.'}, {'measure': 'Technical success of endoscopic interventions in pancreatic fluid collections.', 'timeFrame': '6 months', 'description': 'Technical success of endoscopic interventions in pancreatic fluid collections.'}, {'measure': 'Inflammatory response and organ failure in patients undergoing endoscopic therapy for pancreatic fluid collections.', 'timeFrame': '6 months', 'description': 'Rate of inflammatory response and organ failure in patients undergoing endoscopic therapy for pancreatic fluid collections.'}, {'measure': 'Disease-related adverse events', 'timeFrame': '6 monthts', 'description': 'Rate of disease-related adverse events'}, {'measure': 'Procedure-related adverse events', 'timeFrame': '6 months', 'description': 'Procedure-related adverse events in patients undergoing endoscopic management of pancreatic fluid collection'}, {'measure': 'Timing of intervention', 'timeFrame': '6 months', 'description': 'Intervention at 4 weeks since onset of pancreatitis (traditional approach) versus intervention when the area of necrosis is contained or only partially encapsulated.'}, {'measure': 'Hounsfield units of the pancreatic fluid collection', 'timeFrame': '6 months', 'description': 'Impact of hounsfield units in the necrotic collection on endoscopic intervention'}, {'measure': 'Impact of partial versus full encapsulation of pancreatic fluid collections', 'timeFrame': '6 months', 'description': 'Impact of partial versus full encapsulation of pancreatic fluid collections on endoscopic intervention'}, {'measure': 'Incidence of disconnected pancreatic duct syndrome and sequelae of disconnected pancreatic duct syndrome', 'timeFrame': '3 years', 'description': 'Incidence of disconnected pancreatic duct syndrome and sequelae of disconnected pancreatic duct syndrome'}, {'measure': 'Hospital admission', 'timeFrame': '6 months', 'description': 'Rate of hospital readmissions due to disease-related or procedure-related events in patients undergoing endoscopic therapy for pancreatic fluid collections.'}, {'measure': 'Disease recurrence', 'timeFrame': '3 years', 'description': 'Rate of disease recurrence in patients undergoing endoscopic management of pancreatic fluid collections'}, {'measure': 'Diabetes', 'timeFrame': '3 years', 'description': 'Rate of diabetes'}, {'measure': 'Exocrine pancreatic insufficiency', 'timeFrame': '3 years', 'description': 'Rate of exocrine pancreatic insufficiency'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Pancreatitis', 'Pancreatic Pseudocyst', 'Pancreatic Necrosis']}, 'descriptionModule': {'briefSummary': 'Acute pancreatitis is one of the most common gastrointestinal disorders requiring hospitalization worldwide. Pancreatic fluid collections can occur as a consequence of acute and chronic pancreatitis and can result in significant morbidity and mortality, including significant abdominal pain, gastric outlet obstruction, biliary obstruction, organ failure, persistent unwellness, infection and sepsis.\n\nSymptomatic pancreatic fluid collections require treatment, and endoscopic drainage is considered standard of care. The aim of this study is to evaluate the treatment outcomes in patients undergoing standard of care, endoscopic treatment of pancreatic fluid collections.', 'detailedDescription': 'Acute pancreatitis has an annual incidence of 13-45 cases per 100,000 persons and is one of the most common gastrointestinal disorders requiring hospitalization worldwide. It leads to over a quarter of a million hospital admissions annually in the United States, and inpatient costs exceeding 2.5 billion US dollars. Pancreatic fluid collections can occur as a consequence of acute and chronic pancreatitis and can result in significant morbidity and mortality, including significant abdominal pain, gastric outlet obstruction, biliary obstruction, organ failure, persistent unwellness, infection and sepsis.\n\nSymptomatic pancreatic fluid collections require treatment, and endoscopic drainage is considered standard of care. Endoscopic treatment involves the drainage of the fluid collection into the stomach or duodenum by placement of metal or plastic stents. If clinically indicated, endoscopic necrosectomy is also performed, which is the removal of devitalized pancreatic tissue using the endoscope. Currently the treatment success rate of endoscopic treatment of pancreatic fluid collections exceeds 90%.\n\nThe aim of this study is to evaluate the treatment outcomes in patients undergoing standard of care, endoscopic treatment of pancreatic fluid collections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pancreatic fluid collections', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* All patients undergoing endoscopic treatment of pancreatic fluid collections\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Patients who did not receive endoscopic treatment of pancreatic fluid collections'}, 'identificationModule': {'nctId': 'NCT06179459', 'briefTitle': 'Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections', 'organization': {'class': 'OTHER', 'fullName': 'Orlando Health, Inc.'}, 'officialTitle': 'Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections', 'orgStudyIdInfo': {'id': '22.060.03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Endoscopic management of pancreatic fluid collections', 'type': 'PROCEDURE', 'description': 'Patients with pancreatic fluid collections will be undergoing EUS-guided drainage and/or endoscopic necrosectomy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21806', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ji Young Bang', 'role': 'CONTACT', 'email': 'jiyoung.bang@orlandohealth.com', 'phone': '321-841-2431'}, {'name': 'Barbara J Broome', 'role': 'CONTACT', 'email': 'barbara.broome@orlandohealth.com', 'phone': '321-841-4356'}], 'facility': 'Orlando Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'centralContacts': [{'name': 'Ji Young Bang', 'role': 'CONTACT', 'email': 'jiyoung.bang@orlandohealth.com', 'phone': '321-841-2431'}, {'name': 'Barbara J Broome', 'role': 'CONTACT', 'email': 'barbara.broome@orlandohealth.com', 'phone': '321-841-4356'}], 'overallOfficials': [{'name': 'Ji Young Bang, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orlando Health, Digestive Health Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orlando Health, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}