TEUS Registry: Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry Study
Study Details
Study Description
Brief Summary
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).
-
To assess the clinical and technical success rates of EUS-Guided interventions
-
To document the impact of therapeutic EUS procedures on the management of gastrointestinal disorders including malignancies through cost effective analyses.
-
Compare endoscopic interventions to non-endoscopic interventions for the same clinical indications and evaluate safety and efficacy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
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.
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Procedure: Therapeutic Endoscopic Ultrasound
Therapeutic Endoscopic Ultrasound or Interventional Endoscopy for Gastrointestinal Indications
|
Outcome Measures
Primary Outcome Measures
- Efficacy of Procedure [Upto 2 years]
Technical and clinical success rates
- Safety of procedure [Upto 2 years]
Type, frequency and intensity of adverse events
Secondary Outcome Measures
- Cost Effectiveness [Upto 2 years]
Total cost associated with procedures
Eligibility Criteria
Criteria
Inclusion Criteria:
- Subjects undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications
Exclusion Criteria:
- Subjects not undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University | New Brunswick | New Jersey | United States | 08901 |
Sponsors and Collaborators
- Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
Investigators
- Principal Investigator: Michel Kahaleh, MD, Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro2020002795