Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT05051358
Status:
UNKNOWN
Last Update Posted:
2023-05-26
First Post:
2021-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-25', 'studyFirstSubmitDate': '2021-09-03', 'studyFirstSubmitQcDate': '2021-09-10', 'lastUpdatePostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Procedure', 'timeFrame': 'Upto 2 years', 'description': 'Technical and clinical success rates'}, {'measure': 'Safety of procedure', 'timeFrame': 'Upto 2 years', 'description': 'Type, frequency and intensity of adverse events'}], 'secondaryOutcomes': [{'measure': 'Cost Effectiveness', 'timeFrame': 'Upto 2 years', 'description': 'Total cost associated with procedures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Therapeutic Endoscopic Ultrasound', 'Advanced Endoscopy', 'Therapeutic Endoscopy', 'Interventional Endoscopy', 'Interventional Endoscopic Ultrasound', 'Gastro-Intestinal Disorder', 'Gastrointestinal Disease', 'Gastrointestinal Cancer', 'Gastrointestinal Dysfunction', 'Gastrointestinal Fistula', 'Gastrointestinal Infection', 'Gastrointestinal Injury', 'Pancreatic Disease', 'Bile Duct Diseases']}, 'referencesModule': {'references': [{'pmid': '38713274', 'type': 'DERIVED', 'citation': 'Karanfilian B, Tyberg A, Sarkar A, Shahid HM, Simon A, Reinoso K, Bapaye A, Gandhi A, Gadhikar HP, Dorwat S, Raina H, Ansari J, Nieto J, Qadir N, Porfilio MG, Arevalo-Mora M, Puga-Tejada M, Alcivar-Vasquez J, Robles-Medranda C, Ardengh JC, Bareket R, Liao K, Patel R, Pimpinelli S, Gaidhane M, Kahaleh M. Impact of COVID-19 Infection on Pancreato-Biliary Diseases Requiring Endoscopic Retrograde Cholangiopancreatography. Dig Dis Sci. 2024 Aug;69(8):3015-3018. doi: 10.1007/s10620-024-08454-1. Epub 2024 May 7.'}, {'pmid': '37141073', 'type': 'DERIVED', 'citation': 'Tyberg A, Duarte-Chavez R, Shahid HM, Sarkar A, Simon A, Shah-Khan SM, Gaidhane M, Mohammad TF, Nosher J, Wise SS, Needham V, Kheng M, Lajin M, Sojitra B, Wey B, Dorwat S, Raina H, Ansari J, Gandhi A, Bapaye A, Shah-Khan SM, Krafft MR, Thakkar S, Singh S, Bane JR, Nasr JY, Lee DP, Kedia P, Arevalo-Mora M, Del Valle RS, Robles-Medranda C, Puga-Tejada M, Vanella G, Ardengh JC, Bilal M, Giuseppe D, Arcidiacono PG, Kahaleh M. Endoscopic Ultrasound-Guided Gallbladder Drainage Versus Percutaneous Drainage in Patients With Acute Cholecystitis Undergoing Elective Cholecystectomy. Clin Transl Gastroenterol. 2023 Jun 1;14(6):e00593. doi: 10.14309/ctg.0000000000000593.'}, {'pmid': '36730114', 'type': 'DERIVED', 'citation': 'Tyberg A, Sarkar A, Shahid HM, Shah-Khan SM, Gaidhane M, Simon A, Eisenberg IA, Lajin M, Karagyozov P, Liao K, Patel R, Zhao E, Martinez MG, Artifon EL, Lino AD, Vanella G, Arcidiacono PG, Kahaleh M. EUS-Guided Biliary Drainage Versus ERCP in Malignant Biliary Obstruction Before Hepatobiliary Surgery: An International Multicenter Comparative Study. J Clin Gastroenterol. 2023 Oct 1;57(9):962-966. doi: 10.1097/MCG.0000000000001795.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this retrospective chart-review registry study is to evaluate the safety profile, efficacy profile and cost-effectiveness of the various therapeutic endoscopic ultrasound (EUS) procedures (for benign and malignant gastrointestinal disorders).\n\n1. To assess the clinical and technical success rates of EUS-Guided interventions\n2. To document the impact of therapeutic EUS procedures on the management of gastrointestinal disorders including malignancies through cost effective analyses.\n3. Compare endoscopic interventions to non-endoscopic interventions for the same clinical indications and evaluate safety and efficacy.', 'detailedDescription': 'Our tertiary-care institution performs clinically-indicated therapeutic Endoscopic Ultrasound (TEUS) guided interventions, including biliary and pancreatic drainage, for both malignant and benign gastrointestinal indications in more than 2000 patients annually.\n\nProcedures such as biliary and/or pancreatic sphincterotomy, stents placement (metallic or plastic) and removal for revision, cysts and pseudocysts drainage are conducted in patients suffering from pancreatico-biliary disorders, gastrointestinal disorders and esophageal disorders.\n\nTEUS procedures are less invasive approach than surgery. Moreover, they can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.\n\nThey improve quality of life and extend survival duration.\n\nCurrently, there is limited multi-center data on therapeutic endoscopy clinical outcomes and standardized treatment algorithms in western populations. Due to continuing variations in therapeutic EUS procedures, as well as introduction of some TEUS procedure accessories; it is necessary to periodically evaluate the efficacy and safety of specific TEUS procedures and accessories for several indications to check for improved clinical outcomes.\n\nEvaluation of these clinical details would help us compare them to conventional treatment modalities within our current facility and scope of practice; and consequently, help us identify safe and cost-effective treatment techniques, develop treatment algorithms and improve clinical management of patients at RWJMS and other tertiary-care centers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications\n\nExclusion Criteria:\n\n* Subjects not undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications'}, 'identificationModule': {'nctId': 'NCT05051358', 'acronym': 'TEUS Registry', 'briefTitle': 'Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry Study', 'organization': {'class': 'OTHER', 'fullName': 'Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University'}, 'officialTitle': 'Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry', 'orgStudyIdInfo': {'id': 'Pro2020002795'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects undergoing Therapeutic Endoscopic Ultrasound', 'description': 'Procedures that will be captured include:\n\nEUS- ERCP, Endoscopic Hepatology - EUS, EUS-Coils placement, EUS Glue injection, EUS-Fiducial placement, EUS-Neurolysis, EUS-Stent placement, EUS-alcohol injection, EUS-guided Ablation, EUS-guided anastomosis, EUS Guided ERCP for gallbladder, pancreatic duct or biliary duct drainage, EUS guided - Hemostasis, EUS guided- Therapy for cancer or premalignant lesion (Injection, neurolysis, fiducial, aspiration, RFA ), EUS - Fluid Collection, abscess or cavity drainage, EUS - Guided Ductal Drainage, EUS - Guided Anastomosis', 'interventionNames': ['Procedure: Therapeutic Endoscopic Ultrasound']}], 'interventions': [{'name': 'Therapeutic Endoscopic Ultrasound', 'type': 'PROCEDURE', 'description': 'Therapeutic Endoscopic Ultrasound or Interventional Endoscopy for Gastrointestinal Indications', 'armGroupLabels': ['Subjects undergoing Therapeutic Endoscopic Ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Michel Kahaleh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will not be made available to other out-of-site researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}