Safety and Efficacy of EUS-RFA in the Treatment of Pancreatic Lesions: A Prospective Registry

The University of Texas System (UT)

Status: Active, not recruiting

Conditions: Pancreatic Cyst

Treatments: Device: EUS-guided RFA treatment

Study type: Observational

Funder types: Other

Identifiers

NCT07136324

HSC-MS-18-0192

Details and patient eligibility

About

Purpose: The purpose of this registry is to track the clinical outcomes and progression of patients with pancreatic lesions receiving endoscopic ultrasound (EUS)-based radiofrequency ablation (RFA) therapy.

Research Design: This study is a 7-year, single-center prospective registry study with annual follow up. Patients with pancreatic lesions undergoing EUS-guided RFA treatment will be studied. There will be no deviation from standard of care procedures.

Procedures to be Used: Following recruitment into the program, eligible patients will undergo EUS-RFA for the treatment of their pancreatic lesion and/or malignancy as part of their standard of care.

Endoscopic Intervention: The EUS-guided intervention will be performed based on a clinical decision. The data will be collected for research purposes. Briefly, the procedure involves advancing a 19-gauge EUS-RFA catheter into the target lesion under EUS-guidance. RFA energy is then applied in 2-10 cycles with each cycle lasting about 10 to 30 seconds and the power setting ranging from 10 to 30 Watts. The same physician who performs the initial EUS-RFA procedure will be responsible for subsequent EUS-RFA procedures.

Risks and Potential Benefits: This is a minimal-risk study with associated physical risks being those part of routine standard of care. Additional risks associated with this study include the possible loss of confidentiality if the patient data or information is inadvertently disclosed outside of this study, risks associated with obtaining blood samples, and risks associated with obtaining tissue samples via biopsy. However, all information will be kept strictly confidential and will be used only for research purposes by the listed investigators. Patients will not receive any additional benefit from the study aside from those received as part of standard of care.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of any pancreatic premalignant lesion and/or pancreatic malignancy

Exclusion criteria

1. Patients with co-existing malignancies of other organs (or a prior history of such)
2. Patients unable to provide informed consent
3. Patients unable to complete follow-up

Trial design

100 participants in 1 patient group

Patients with pancreatic lesions

Description:

Patients with pancreatic lesions undergoing EUS-guided RFA treatment. Patients of either gender that are 18 years of age or older.

Treatment:

Device: EUS-guided RFA treatment