Endoscopic Ultrasound-Guided Radiofrequency Ablation for Pancreatic Cancer

(ERASE Trial)

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Benign PCL, Malignant PCN, Acute pancreatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 year

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) for individuals with high-risk pancreatic cysts that could become cancerous. The goal is to determine if this less invasive method can safely and effectively destroy these cysts without surgery. This trial may suit individuals with a pancreatic cyst at least 2 cm in size with concerning features, who cannot or choose not to undergo surgery due to other health issues or personal preference. As an unphased trial, it provides an opportunity to explore innovative treatment options for those seeking alternatives to surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this endoscopic ultrasound-guided radiofrequency ablation is safe for pancreatic tumors?

Research has shown that endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) is generally safe for treating pancreatic issues. Studies have found that patients typically tolerate EUS-RFA well, with most experiencing only mild side effects, if any.

A review of multiple studies on EUS-RFA concluded that it is a safe procedure for pancreatic cancer. It is practical to perform and has not raised major safety concerns in patients with advanced pancreatic cancer.

In summary, EUS-RFA is considered a safe treatment option for managing pancreatic tumors and growths. It uses electrical energy and heat to target and destroy cancer cells, offering a less invasive alternative to surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA) is unique because it combines advanced imaging and targeted therapy to tackle pancreatic cancer. Unlike traditional treatments like surgery, chemotherapy, or radiation, EUS-RFA uses high-frequency radio waves delivered directly to the tumor through an endoscope, which is a flexible tube inserted through the mouth. This allows for precise destruction of cancer cells with minimal damage to surrounding tissues. Researchers are excited about this technique as it offers a less invasive option with potentially fewer side effects and quicker recovery times, while also allowing for repeated treatments if necessary.

What evidence suggests that endoscopic ultrasound-guided radiofrequency ablation is effective for pancreatic cancer?

Research has shown that endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA), the treatment under study in this trial, offers a promising option for pancreatic tumors, particularly for patients unable to undergo surgery. Studies have found that EUS-RFA effectively targets and destroys cancer cells using electrical energy and heat. This method is less invasive than traditional surgery, resulting in fewer complications. While surgery remains the best option for many, EUS-RFA provides a valuable alternative for those who cannot have surgery. Early reports suggest that EUS-RFA can halt the progression of high-risk tumors and reduce the need for frequent check-ups. ^{1 3 6 7 8}

Who Is on the Research Team?

Somashekar G. Krishna, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Capable of giving written informed consent

You are expected to live for at least 1 more year.

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

Exclusion Criteria

Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it unsafe for the patient to participate in the study

I cannot have general anesthesia as determined by a pre-op assessment.

My pancreatic cyst is not cancerous, confirmed by specific tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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.

1 year

Multiple visits for EUS-RFA and imaging assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up every 3-6 months for cysts >= 3 cm or every 6-12 months for cysts < 3 cm for up to 3 years.

3 years

Regular follow-up visits every 3-12 months

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic Ultrasound-Guided Radiofrequency Ablation

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (EUS-RFA) Experimental Treatment 7 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.

Endoscopic Ultrasound-Guided Radiofrequency Ablation is already approved in United States, European Union for the following indications:

Approved in United States as EUS-RFA for:

• Pancreatic neuroendocrine tumors
• Cystic pancreatic neoplasms
• Unresectable pancreatic cancer

Approved in European Union as EUS-RFA for:

• Pancreatic neuroendocrine tumors
• Cystic pancreatic neoplasms
• Locally advanced pancreatic cancer

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

EUS-guided radiofrequency ablation (EUS-RFA) was found to be feasible and effective in creating a necrotic lesion in the pancreas of 10 adult mini pigs, with an average ablation diameter of 23.0 mm.

The procedure showed a good safety profile, as no major complications occurred and all pigs survived without distress for 7 days post-procedure, indicating potential for further research in human applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EUS-guided radiofrequency ablation of the porcine pancreas. Kim, HJ., Seo, DW., Hassanuddin, A., et al.[2016]

Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) was successfully performed in 8 out of 9 patients with pancreatic neoplasms, demonstrating a 100% feasibility rate.

The procedure showed no major adverse events during a mean follow-up of 6 months, indicating it is a safe option for treating pancreatic tumors, although mild abdominal pain was reported in three patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EUS-guided Radiofrequency Ablation (EUS-RFA) of Solid Pancreatic Neoplasm Using an 18-gauge Needle Electrode: Feasibility, Safety, and Technical Success. Crinò, SF., D'Onofrio, M., Bernardoni, L., et al.[2019]

Endoscopic ultrasound (EUS) guided fine-needle aspiration (FNA) is a safe and accurate method for diagnosing intrathoracic and intraabdominal conditions, but it carries a low risk of adverse events such as perforation, infections, and bleeding.

The review highlights specific risks associated with EUS FNA, including complications like pancreatitis and bile duct leaks, and offers strategies to minimize these risks during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Basic techniques in endoscopic ultrasound-guided fine needle aspiration for solid lesions: Adverse events and avoiding them. Fujii, LL., Levy, MJ.[2021]

A systematic review of 14 studies involving 120 patients undergoing endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) for pancreatic solid masses showed a high technical success rate of 99.0%.

The procedure demonstrated a low overall adverse event rate of 8.0%, with serious adverse events occurring in only 1.0% of cases, and no reported mortality, indicating that EUS-RFA is a safe and feasible treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided ablation of solid pancreatic lesions: A systematic review of early outcomes with pooled analysis. Spadaccini, M., Di Leo, M., Iannone, A., et al.[2022]

EUS-guided radiofrequency ablation (RFA) has shown clinical success in treating insulinomas in three elderly patients, leading to symptom relief and no need for medications after 24 months of follow-up.

The procedure was performed safely with only one minor adverse event (intraprocedural bleeding), suggesting that EUS-RFA is a viable alternative to surgery for patients unfit for surgical intervention, although further studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound radiofrequency ablation of pancreatic insulinoma in elderly patients: Three case reports. Rossi, G., Petrone, MC., Capurso, G., et al.[2022]

The study demonstrated that endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA) can safely and effectively ablate mediastinal lymph nodes in a porcine model, with no complications observed during the procedure.

A total of 18 lymph nodes were successfully ablated, achieving a mean necrosis diameter of 5.5 mm, indicating that this technique could be a promising option for future clinical applications in treating lymph node tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided lymph node ablation with a novel radiofrequency ablation probe: feasibility study in an acute porcine model. Sethi, A., Ellrichmann, M., Dhar, S., et al.[2014]

In a study of 100 patients undergoing EUS-guided radiofrequency ablation (EUS-RFA) for pancreatic neoplasms, the procedure demonstrated a good safety profile with no procedure-related deaths and a total of 22 adverse events reported.

The study found that 60.2% of patients achieved complete tumor response, particularly for small neuroendocrine neoplasms (NENs) and tumors less than 20 mm in size, indicating EUS-RFA is an effective treatment option for certain pancreatic tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for EUS-guided radiofrequency ablation adverse events in patients with pancreatic neoplasms: a large national French study (RAFPAN study). Napoléon, B., Lisotti, A., Caillol, F., et al.[2023]

Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) was successfully performed on 11 patients with unresectable pancreatic cancer, demonstrating technical feasibility and safety with no major adverse events reported.

After treatment, some patients showed promising results, including decreased tumor sizes and lower serum CA19-9 levels, suggesting short-term efficacy of this approach in managing pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided radiofrequency ablation of unresectable pancreatic cancer with low ablation power and multiple applications: a preliminary study of 11 patients. Wang, J., Wang, Y., Zhao, Y., et al.[2021]

Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) has shown a 100% technical success rate in treating pancreatic neoplasms, making it a highly effective option for patients.

While there are some reported complications associated with EUS-RFA, serious life-threatening outcomes are rare, suggesting that it is a safe alternative to more invasive surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Ultrasound-Guided Radiofrequency Ablation of the Pancreatic Tumors: A Promising Tool in Management of Pancreatic Tumors. Changela, K., Patil, R., Duddempudi, S., et al.[2018]

Endoscopic ultrasound (EUS) radiofrequency ablation (RFA) using a novel monopolar probe was successfully performed on 8 patients with pancreatic neoplasms, showing promising results in terms of safety and feasibility, with no major complications observed.

Among patients with cystic neoplasms, 2 out of 6 experienced complete resolution of their cysts, while others showed an average size reduction of 48.4%, indicating the potential efficacy of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound guided radiofrequency ablation, for pancreatic cystic neoplasms and neuroendocrine tumors. Pai, M., Habib, N., Senturk, H., et al.[2020]

EUS-guided radiofrequency ablation (EUS-RFA) is a safe and technically feasible treatment for patients with unresectable pancreatic cancer, with only a 3.74% rate of early procedure-related adverse events.

In a study of 22 patients, EUS-RFA combined with chemotherapy resulted in a median overall survival of 24.03 months and a median progression-free survival of 16.37 months, suggesting potential benefits in survival outcomes for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of EUS-guided radiofrequency ablation for unresectable pancreatic cancer: A prospective observational study. Oh, D., Seo, DW., Song, TJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11449472/

Endoscopic Ultrasound-Guided Radiofrequency Ablation ... Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) has been proposed as a treatment for patients who are unfit for surgery or with inoperable PDAC.

2. nature.com nature.com/articles/s41598-022-20316-2

Endoscopic ultrasound-guided radiofrequency ablation ... The aim of this study is to report safety-profile, feasibility and outcomes of EUS-RFA for advanced PDAC.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05916846

Study Details | NCT05916846 | Evaluation of Endoscopic ... This clinical trial evaluates the safety and effectiveness of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) for the management of patients ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.e16276

Efficacy and the safety of endoscopic ultrasound guided ... The primary outcomes were the technical (TS) and clinical success rate (CS) of the EUS-RFA procedure, while the secondary outcome was the adverse events (AEs) ...

5. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2024.1367068/full

Outcomes of endoscopic ultrasound-guided ablation and ... EUS-guided ablation is associated with a lower AE rate and a shorter length of hospital stay, but a higher recurrence rate for the treatment of insulinoma ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36192558/

Endoscopic ultrasound-guided radiofrequency ablation ... The aim of this study is to report safety-profile, feasibility and outcomes of EUS-RFA for advanced PDAC. Prospective review of patients with ...

7. asco.org asco.org/abstracts-presentations/ABSTRACT362694

Efficacy and the safety of endoscopic ultrasound guided ... Efficacy and the safety of endoscopic ultrasound guided radiofrequency ablation of pancreatic cancer: A systematic review and meta-analysis. download.

8. mdpi.com mdpi.com/2075-4418/15/4/437

Endoscopic Ultrasound-Guided Radiofrequency Ablation ... EUS-RFA is a technically feasible and safe procedure for treating uPDAC or mPDAC and is under investigation for use in resectable PDAC.