Safety and Efficacy of Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) in the Treatment of Pancreatic Lesions

NCT07737171 | Recruiting DMC FDA Device

• 1 other identifier: HSC-MS-24-1077
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 7-year prospective single-center registry study to assess the safety and efficacy of Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) in the treatment of pancreatic lesions.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Number of participants for whom there is technical success of tumor treatment

  Technical success of tumor treatment is defined as successful delivery of EUS-guided radiofrequency ablation (RFA) energy to the target pancreatic lesion with: * Accurate placement of the RFA probe within the intended lesion under EUS guidance * Completion of the planned ablation cycles * Immediate post-ablation sonographic evidence of treatment effect (e.g., hyperechoic changes within lesion indicating coagulative necrosis)

  From time of the procedure to about 3 months post procedure

Secondary Outcomes (3)

• Number of participants with post-procedure complications observed within 30 days

  from the time of the procedure to 30 days after the procedure

• Reduction in the size of the tumor

  baseline, 3 months, 6 months, 3 years

• Reduction in systemic tumor markers

  baseline, at the time of the first RFA (about 1 month after baseline), at the time of the second RFA (about 2 months after baseline), at the time of the third RFA (about 3 month after baseline)

Study Arms (1)

Adult patients who undergo EUS-RFA for treatment of pancreatic lesions

Device: Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA)

Interventions

Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) DEVICE

EUS-guided Radiofrequency Ablation (RFA) consists of the application of alternating current with a frequency of 350-500 kHz (coincidentally the frequency range of radio broadcasts as well) to the target tissue via a special electrode located at the tip of the endoscope.

Adult patients who undergo EUS-RFA for treatment of pancreatic lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population is recruited from the PI's and Co-I's daily clinic

You may qualify if:

• Diagnosis of any pancreatic pre-malignant lesion and/or pancreatic malignancy
• Patients already undergoing EUS-RFA for treatment of pancreatic lesions clinically

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample - collecting plasma and serum at each Radiofrequency Ablation (RFA)

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Endosonography

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nirav Thosani, MD

  The University of Texas Health Science Center at Houston (UTHealth Houston)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amatullah Alibhai, MBA

CONTACT

713-500-6658; Amatullah.Alibhai@uth.tmc.edu

Nicole Fatheree, BBA

CONTACT

713-500-5669; Nicole.Fatheree@uth.tmc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): April 1, 2033
• Study Completion (Estimated): April 1, 2033
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

US (1)