EUS-Guided RFA for Pancreatic Cysts (ERASE Trial)

N/A

Recruiting

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time point 1: immediately post-procedure (after eus-rfa) in endoscopy unit up to 24 hours after procedure; time point 2: at one calendar year after eus-rfa

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a procedure that uses heat to destroy abnormal growths in the pancreas. It targets patients who cannot have surgery due to high risks. The heat is delivered through a special tool inserted via an endoscope. Early results show that this method is safe and feasible for patients who cannot undergo surgery.

Who is the study for?

This trial is for adults over 18 with pancreatic cysts who are high-risk for surgery due to conditions like liver cirrhosis, obesity, heart/lung issues, or by choice. They must have a specific type of cyst at least 2cm large and not be candidates for surgical treatment. Women must test negative for pregnancy.

What is being tested?

The ERASE study tests the safety and effectiveness of using an FDA-cleared device (EUS-RFA probe) to perform radiofrequency ablation on pancreatic cysts in patients unsuitable for surgery. Participants will undergo this procedure and then be monitored regularly over three years.

What are the potential side effects?

Potential side effects may include discomfort at the site of ablation, risk of infection, possible damage to nearby organs or blood vessels if the cyst is close to these structures, pancreatitis, or allergic reactions related to sedation during endoscopic procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at two and three calendar years after eus-rfa

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at two and three calendar years after eus-rfa

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess the efficacy of EUS-RFA post-procedure after one year

Secondary study objectives

Assess the long-term response to EUS-RFA for efficacy of significant and durable ablation response

Incidence of adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: EUS-guided radiofrequency ablation of pancreatic cystic lesion(s)Experimental Treatment2 Interventions

Single arm study. EUS-guided intervention with radiofrequency ablation of pancreatic cystic lesions. Primary population of interest: Branch duct IPMN (intraductal papillary mucinous neoplasm) with high-risk for surgical intervention. The intervention is performed using an FDA-cleared device (EUS-RFA probe).

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