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

Trial Summary

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 data supports the effectiveness of the treatment Endoscopic Ultrasound-Guided Radiofrequency Ablation for Pancreatic Cancer?

Research shows that Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA) is a promising and less invasive treatment for pancreatic cancer, with studies reporting a 100% technical success rate and suggesting it may be a safe and effective alternative for managing certain patients. ^{1 2 3 4 5}

Is EUS-guided radiofrequency ablation generally safe for humans?

Research on EUS-guided radiofrequency ablation (EUS-RFA) for pancreatic conditions suggests it is generally safe, with studies focusing on its feasibility and safety. However, like any medical procedure, there are potential risks, including infections, bleeding, and pancreatitis (inflammation of the pancreas). ^{1 2 6 7 8}

How is the treatment Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA) different from other treatments for pancreatic cancer?

Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA) is unique because it uses a special probe to deliver heat directly to the tumor through an endoscope, which is a flexible tube inserted into the body, allowing for precise targeting of the cancerous tissue. This method is particularly useful for patients with tumors that cannot be surgically removed, offering a minimally invasive option compared to traditional surgery. ^{1 2 9 10 11}

What is the purpose of this trial?

This clinical trial evaluates the safety and effectiveness of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) for the management of patients with pancreatic tumors (including cysts) performed during recommended surveillance endoscopic ultrasound examinations. Pancreatic tumors (cysts) can progress to pancreatic cancer at rate of more than 25% per year risk. Pancreatic cancer is a fatal disease that is difficult to diagnose at an early stage, and the five-year survival rate is currently less than 10%. It is projected to be the second leading cause of cancer-related mortality by the year 2030. A procedure known as radiofrequency ablation may help. Radiofrequency ablation is an established way to treat benign and cancerous tumors in the human body. In the last 5 years, radiofrequency ablation has been applied to treat precancerous tumors (including cysts) in the pancreas. This procedure implements a medical technology that destroys tumors in a much less invasive way compared to traditional surgical removal. By delivering a high-frequency alternating current, radiofrequency ablation uses electrical energy and heat to destroy cancer cells. Radiofrequency ablation is being recognized as a management option in patients with high-risk pancreatic tumors (cysts) but are not deemed surgical candidates. While surgical removal offers a chance of cure, pancreatic surgeries have 20-40% morbidity rate (short and long-term complication) and a 1-2% mortality rate in patients who are surgical candidates. Furthermore, radiofrequency ablation can potentially decrease the need for frequent imaging/surveillance of the pancreatic tumor (cyst). In patients with immediate prohibitive, but reversible risks for surgery, radiofrequency ablation of a high-risk tumors (cysts) can potentially prevent further progression of the lesion and bridge the time before the need for surgical resection.

Research Team

Somashekar G. Krishna, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

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

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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]

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]

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]

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]

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 (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]

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]

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]

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]

References

1. China 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. [2021]

2. Romania 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. [2019]

3. China pubmed.ncbi.nlm.nih.gov

Clinical outcomes of EUS-guided radiofrequency ablation for unresectable pancreatic cancer: A prospective observational study. [2022]

4. Egypt pubmed.ncbi.nlm.nih.gov

Endoscopic Ultrasound-Guided Radiofrequency Ablation of the Pancreatic Tumors: A Promising Tool in Management of Pancreatic Tumors. [2018]

5. China pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided ablation of solid pancreatic lesions: A systematic review of early outcomes with pooled analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound guided radiofrequency ablation, for pancreatic cystic neoplasms and neuroendocrine tumors. [2020]

7. United States 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). [2023]

8. China pubmed.ncbi.nlm.nih.gov

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

9. Germany pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided lymph node ablation with a novel radiofrequency ablation probe: feasibility study in an acute porcine model. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

EUS-guided radiofrequency ablation of the porcine pancreas. [2016]

11. United States pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound radiofrequency ablation of pancreatic insulinoma in elderly patients: Three case reports. [2022]