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Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry Study

Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05051358
Acronym
TEUS Registry
Enrollment
5000
Registered
2021-09-21
Start date
2021-02-11
Completion date
2023-12-10
Last updated
2023-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Endoscopy, Bile Duct Diseases, Gastrointestinal Cancer, Gastrointestinal Disease, Gastro-Intestinal Disorder, Gastrointestinal Dysfunction, Gastrointestinal Fistula, Gastrointestinal Infection, Gastrointestinal Injury, Interventional Endoscopic Ultrasound, Interventional Endoscopy, Pancreatic Disease, Therapeutic Endoscopic Ultrasound, Therapeutic Endoscopy

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). 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.

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.

Interventions

Therapeutic Endoscopic Ultrasound or Interventional Endoscopy for Gastrointestinal Indications

Sponsors

Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of ProcedureUpto 2 yearsTechnical and clinical success rates
Safety of procedureUpto 2 yearsType, frequency and intensity of adverse events

Secondary

MeasureTime frameDescription
Cost EffectivenessUpto 2 yearsTotal cost associated with procedures

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026