EUS-Guided RFA for Pancreatic Cysts

(ERASE Trial)

Overseen By Megan E Fry, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

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

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating pancreatic cysts, which are fluid-filled sacs in the pancreas that can sometimes pose risks. The trial examines the safety and effectiveness of EUS-guided radiofrequency ablation (RFA). This technique targets the cysts without requiring surgery. Individuals with pancreatic cysts who cannot undergo surgery and have had medical evaluations may qualify for this trial. Researchers will monitor participants for three years after treatment to track progress. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new treatment options for pancreatic cysts.

Do I need to stop my current medications for the trial?

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 EUS-guided radiofrequency ablation is safe for pancreatic cystic lesions?

Research has shown that a new treatment called EUS-guided radiofrequency ablation (RFA) holds promise for safely treating pancreatic cysts. This method, less invasive than traditional surgery, can effectively shrink pancreatic growths. For instance, one study found that it significantly reduced cyst size and improved genetic markers related to tumors.

Another study confirmed that EUS-RFA works well for different types of pancreatic growths, especially certain tumors. Patients who received this treatment often needed fewer follow-up visits, indicating a lower risk of complications.

While these results are encouraging, it's important to remember that this procedure is still under study. However, current research reports positive safety information, with no major issues observed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about EUS-guided radiofrequency ablation (RFA) for treating pancreatic cysts because it offers a minimally invasive alternative to surgery. Unlike traditional treatments that might require extensive surgical procedures, this method uses an endoscopic ultrasound (EUS) to precisely deliver radiofrequency energy to the cyst, potentially reducing recovery time and risks associated with surgery. This approach specifically targets high-risk branch duct IPMNs, aiming to ablate the cystic lesions directly, which could improve outcomes without the need for more invasive interventions.

What evidence suggests that EUS-guided radiofrequency ablation is effective for pancreatic cysts?

Research has shown that EUS-guided radiofrequency ablation (RFA), the treatment under study in this trial, offers a promising approach for pancreatic cysts. One study found that EUS-RFA significantly reduced cyst size and the presence of KRAS mutations, important indicators of treatment success. Another study reported that patients did not experience a return of cysts or develop related cancers after treatment, allowing for fewer medical check-ups. While research continues, these findings suggest that EUS-RFA can be an effective and minimally invasive option for treating potentially dangerous pancreatic cysts. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am older than 18 years.

Estimated life expectancy of at least 1 year

Exclusion Criteria

I am unable to care for myself and spend most of my time in bed or a chair.

My pancreatic cyst has been confirmed as cancerous with signs of spreading.

I have not had acute pancreatitis in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3-6 months

1 visit (in-person)

Pre-treatment/Baseline

Standard of care practices for management of PCNs including imaging and laboratory tests

Up to 6 months

Multiple visits (in-person) for imaging and tests

Treatment

EUS-guided RFA of pancreatic cystic lesions with pre-procedure prophylaxis and post-procedure monitoring

1 day

1 visit (in-person, inpatient admission for overnight observation)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up every 3-12 months based on cyst size

3 years

Regular visits (in-person) for imaging and physical examinations

What Are the Treatments Tested in This Trial?

Interventions

• EUS-guided radiofrequency ablation of pancreatic cyst

Trial Overview 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.

How Is the Trial Designed?

Group I: EUS-guided radiofrequency ablation of pancreatic cystic lesion(s) Experimental Treatment 2 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).

EUS-guided radiofrequency ablation of pancreatic cyst is already approved in United States for the following indications:

Approved in United States as EUS-RFA for:

• Pancreatic cystic neoplasms (PCNs)
• High-risk pancreatic cysts

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

In a study of 10 patients undergoing EUS-guided pancreatic cyst ablation, the peak plasma concentration of paclitaxel was low (up to 17.10 ng/mL), indicating minimal systemic absorption of the drug after local injection.

The procedure was generally safe, with only mild side effects reported, such as abdominal pain in five patients and vomiting in one, suggesting that the treatment is well-tolerated with rare systemic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic effect of endoscopic ultrasonography-guided pancreatic cyst ablation with ethanol and paclitaxel. Oh, HC., Seo, DW., Kim, SH., et al.[2021]

In a study of 146 patients undergoing EUS-guided FNA, the overall adverse event (AE) rate was low at 3.4%, with slightly higher rates in patients with pancreatic cysts (5.5%) compared to solid lesions (1.4%).

Most AEs were mild to moderate and occurred within the first 48 hours, indicating that EUS-FNA is a safe and effective procedure for both pancreatic cysts and solid lesions, warranting close monitoring immediately after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of EUS-guided FNA of pancreatic cystic and solid lesions by using the lexicon proposed in an ASGE workshop: a prospective and comparative study. Rodríguez-D'Jesús, A., Fernández-Esparrach, G., Marra-Lopez, C., et al.[2022]

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]

In a study of 12 patients with pancreatic cysts that had resolved after EUS-guided ethanol lavage, 75% showed no recurrence of cysts during follow-up CT scans conducted a median of 26 months later, indicating durable resolution of the cysts.

The study highlights the effectiveness of EUS-guided ethanol ablation for treating pancreatic cysts, particularly mucinous cysts, but emphasizes the need for longer follow-up to confirm long-term outcomes and consider patients as 'cured.'

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up of pancreatic cysts that resolve radiologically after EUS-guided ethanol ablation. DeWitt, J., DiMaio, CJ., Brugge, WR.[2022]

Endoscopic ultrasound-guided ablation (EUS-A) therapy effectively reduces the residual neoplastic lining in pancreatic cysts, with 67% of cases showing minimal residual epithelial cells after treatment, indicating its potential as a safe option for patients not suitable for surgery.

Histopathological analysis revealed distinctive features such as diffuse egg shell-like calcification and ovarian-type stroma in cysts post-ablation, which can aid in accurate diagnosis of pancreatic cystic tumors even without prior knowledge of EUS-A treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pancreatic Cysts after Endoscopic Ultrasonography-Guided Ethanol and/or Paclitaxel Ablation Therapy: Another Mimic of Pancreatic Pseudocysts. An, S., Sung, YN., Kim, SJ., et al.[2022]

EUS-guided fine-needle aspiration (FNA) of pancreatic cysts has a low complication rate of 2.2%, with complications including pancreatitis and abdominal pain, but no specific patient or cyst characteristics were found to predict these complications.

The study reviewed data from 603 patients over a period from March 1996 to October 2003, indicating that EUS FNA is a safe procedure for pancreatic cysts, with complication rates comparable to those for solid pancreatic lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EUS-guided fine needle aspiration of pancreatic cysts: a retrospective analysis of complications and their predictors. Lee, LS., Saltzman, JR., Bounds, BC., et al.[2022]

Endoscopic ultrasound (EUS)-guided fine-needle aspiration is a minimally invasive technique for managing pancreatic cystic tumors, allowing for both diagnosis and treatment through cyst ablation.

This review highlights the safety and feasibility of EUS-guided cyst ablation, addressing the clinical outcomes and technical considerations necessary for effective management of potentially malignant pancreatic cysts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided ablation therapy for pancreatic cysts. Cho, MK., Choi, JH., Seo, DW.[2020]

A novel radiofrequency ablation device connected to a standard electrosurgical unit effectively ablated pancreatic cysts in a preclinical model, requiring temperatures of at least 60°C to effectively target mucosal crypts.

The study demonstrated that higher temperatures led to greater tissue reduction, with a safe upper limit of 97°C, suggesting this method could provide a low-cost and convenient alternative to traditional pancreatectomy for treating pancreatic cysts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermal ablation of pancreatic cyst with a prototype endoscopic ultrasound capable radiofrequency needle device: A pilot feasibility study. Moris, M., Atar, M., Kadayifci, A., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9914142/

A Review on Endoscopic Ultrasound-Guided ... EUS-RFA offers a minimally invasive and potentially definitive means to treat pancreatic neuroendocrine tumors and precancerous pancreatic cystic lesions.

2. journals.lww.com journals.lww.com/ajg/fulltext/2024/10001/s4_safety_and_efficacy_of_endoscopic.5.aspx

S4 Safety and Efficacy of Endoscopic Ultrasound-Guided... This first prospective trial of EUS-RFA for BD-IPMNs demonstrates a high proportion of clinically significant responses in cyst volume and KRAS mutation burden.

3. giejournal.org giejournal.org/article/S0016-5107(23)03152-8/fulltext

Successful EUS-guided pancreatic cyst chemoablation ... All patients were successfully reduced to annual or less surveillance without recurrence or the development of cyst-associated malignancy.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1521691825000137

Reducing the incidence of pancreatic cancer through ... Currently, the literature on using EUS guided RFA ablation in the management of pancreatic cysts is sparse and studies are emerging in assessing the efficacy ...

5. ijgii.org ijgii.org/journal/view.html?doi=10.18528/ijgii220027

Endoscopic ultrasound-guided ablation of pancreatic cystic ... The results of cystic fluid analysis showed promising results for the efficacy of EUS-guided ablation with ethanol and paclitaxel even for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9257535/

Efficacy and safety of endoscopic ultrasound-guided ... This study demonstrates that EUS-RFA is an effective treatment modality for pancreatic lesions, especially functional neuroendocrine tumors such as insulinomas.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016510723025701

Comparison of outcomes of EUS-guided ablation and ... EUS-REL was associated with a significantly lower 10-year cumulative incidence rate of BD-IPMN progression and a lower tendency of SR, whereas its 10-year OS ...