Clinical trial NCT05051358: Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry Study
Official title: Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications

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.

Eligibility 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

Primary outcomes:
measure: Efficacy of Procedure
timeFrame: Upto 2 years
measure: Safety of procedure
timeFrame: Upto 2 years
Secondary outcomes:
measure: Cost Effectiveness
timeFrame: Upto 2 years
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
state: New Jersey
Study officials:
affiliation: Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
name: Michel Kahaleh, MD
role: PRINCIPAL_INVESTIGATOR
References: