Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry Study

NCT05051358 | Unknown

• 1 other identifier: Pro2020002795
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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. 1.To assess the clinical and technical success rates of EUS-Guided interventions
2. 2.To document the impact of therapeutic EUS procedures on the management of gastrointestinal disorders including malignancies through cost effective analyses.
3. 3.Compare endoscopic interventions to non-endoscopic interventions for the same clinical indications and evaluate safety and efficacy.

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

Outcome Measures

Primary Outcomes (2)

• Efficacy of Procedure

  Technical and clinical success rates

  Upto 2 years

• Safety of procedure

  Type, frequency and intensity of adverse events

  Upto 2 years

Secondary Outcomes (1)

• Cost Effectiveness

  Upto 2 years

Study Arms (1)

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

Interventions

Therapeutic Endoscopic Ultrasound PROCEDURE

Therapeutic Endoscopic Ultrasound or Interventional Endoscopy for Gastrointestinal Indications

Subjects undergoing Therapeutic Endoscopic Ultrasound

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications

You may qualify if:

• Subjects undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications

You may not qualify if:

• Subjects not undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications

Sponsors & Collaborators

• Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University: lead

Study Sites (1)

Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (3)

• 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: 38713274 DERIVED

• 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: 37141073 DERIVED

• 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.

  PMID: 36730114 DERIVED

MeSH Terms

Conditions

Digestive System Diseases; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Digestive System Fistula; Pancreatic Diseases; Bile Duct Diseases

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Biliary Tract Diseases

Study Officials

• Michel Kahaleh, MD

  Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 21, 2021
• Study Start: February 11, 2021
• Primary Completion: December 10, 2023
• Study Completion: December 10, 2023
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)