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Procedure

Endoscopic Ultrasound-Guided Radiofrequency Ablation for Pancreatic Cancer (ERASE Trial)

N/A

Recruiting

Led By Somashekar G Krishna, MD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years

The patient is not a surgical candidate and has had prior attempts at ablation of the PCN by EUS-guided injection of chemotherapy (Ohio State University [OSU] Institutional Review Board [IRB] protocol 2020C0198)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2 and 3 years after eus-rfa

Awards & highlights

ERASE Trial Summary

This trial is testing a less invasive way to treat pancreatic tumors (including cysts) that can progress to cancer, which is difficult to diagnose early and has a low survival rate. Radiofrequency ablation uses electrical energy to destroy cancer cells and could reduce surgery risk.

Who is the study for?

This trial is for adults over 18 who have pancreatic tumors and are not candidates for surgery due to various health risks or personal choice. They must be able to consent, have a life expectancy of at least one year, and women must test negative for pregnancy. It's not suitable for those with severe illnesses, psychiatric disorders that affect consent, recent acute pancreatitis, or certain heart devices.Check my eligibility

What is being tested?

The ERASE Study tests the safety and effectiveness of using radiofrequency ablation guided by endoscopic ultrasound (EUS-RFA) on patients with pancreatic tumors during surveillance exams. This less invasive procedure uses heat from electrical energy to destroy cancer cells in high-risk patients who can't undergo surgery.See study design

What are the potential side effects?

Potential side effects may include discomfort at the treatment site, inflammation of the pancreas (pancreatitis), damage to nearby organs or blood vessels due to heat application, infection risk post-procedure, and possible allergic reactions related to anesthesia used during EUS-RFA.

ERASE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I cannot have surgery and have tried chemotherapy injections for my pancreatic cyst.

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My pancreatic cyst was confirmed with specific advanced tests.

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My pancreatic cyst is at least 2 cm large and has high-risk features.

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I am a woman who can have children and I have a negative pregnancy test.

ERASE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2 and 3 years after eus-rfa

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2 and 3 years after eus-rfa

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 and 3 years after eus-rfa for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA)

Secondary outcome measures

Long-term response to EUS-RFA

Safety of EUS-guided RFA of pancreatic cystic neoplasms at one year

Safety of EUS-guided RFA of pancreatic cystic neoplasms post procedure

ERASE Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (EUS-RFA)Experimental Treatment7 Interventions

Patients undergo standard of care EUS-FNA followed by EUS-RFA on study and may undergo repeat EUS-RFA or EUS-guided chemoablation during surveillance. Patients undergo MRI/MRCP, CT, or EUS-FNA at baseline and at follow-up timepoints.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Cholangiopancreatography

2019

N/A

~230

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Computed Tomography

2017

Completed Phase 2

~2720

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor

320 Previous Clinical Trials

290,135 Total Patients Enrolled

Somashekar G Krishna, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Media Library

Endoscopic Ultrasound-Guided Radiofrequency Ablation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05961982 — N/A

Pancreatic Cancer Research Study Groups: Treatment (EUS-RFA)

Pancreatic Cancer Clinical Trial 2023: Endoscopic Ultrasound-Guided Radiofrequency Ablation Highlights & Side Effects. Trial Name: NCT05961982 — N/A

Endoscopic Ultrasound-Guided Radiofrequency Ablation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05961982 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the number of participants that have been recruited for this clinical trial?

"Affirmative. According to clinicaltrials.gov, this medical experiment was initially posted on April 24th 2023 and is now actively looking for participants. 32 patients are needed from 1 different site in order to complete the trial."

Answered by AI

Is recruitment for this clinical trial still open?

"According to clinicaltrials.gov, this study is currently recruiting participants, with the first posting on April 24th 2023 and the most recent update occurring July 18th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Endoscopic Ultrasound-Guided Radiofrequency Ablation for the Management of Pancreatic Tumors, ERASE Study

Somashekar Krishna 2023. "Evaluation of Endoscopic Ultrasound-Guided Radiofrequency Ablation for the Management of Pancreatic Tumors, ERASE Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05961982.