Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry Study
NCT ID: NCT05051358
Last Updated: 2023-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
5000 participants
OBSERVATIONAL
2021-02-11
2023-12-10
Brief Summary
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1. To assess the clinical and technical success rates of EUS-Guided interventions
2. To document the impact of therapeutic EUS procedures on the management of gastrointestinal disorders including malignancies through cost effective analyses.
3. Compare endoscopic interventions to non-endoscopic interventions for the same clinical indications and evaluate safety and efficacy.
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Detailed Description
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Procedures 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.
TEUS 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.
They improve quality of life and extend survival duration.
Currently, 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.
Evaluation 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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Subjects undergoing Therapeutic Endoscopic Ultrasound
Procedures that will be captured include:
EUS- 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
Therapeutic Endoscopic Ultrasound
Therapeutic Endoscopic Ultrasound or Interventional Endoscopy for Gastrointestinal Indications
Interventions
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Therapeutic Endoscopic Ultrasound
Therapeutic Endoscopic Ultrasound or Interventional Endoscopy for Gastrointestinal Indications
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
OTHER
Responsible Party
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Principal Investigators
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Michel Kahaleh, MD
Role: PRINCIPAL_INVESTIGATOR
Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
Locations
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Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
New Brunswick, New Jersey, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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Pro2020002795
Identifier Type: -
Identifier Source: org_study_id
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