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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment EUS-guided radiofrequency ablation for pancreatic cysts?

Research shows that EUS-guided ablation of pancreatic cysts, which is a minimally invasive technique, has short-term success rates of 33% to 79% in resolving cysts as seen on CT scans. This suggests that EUS-guided radiofrequency ablation could be effective in treating pancreatic cysts. ^{1 2 3 4 5}

Is EUS-guided radiofrequency ablation for pancreatic cysts safe?

EUS-guided radiofrequency ablation (EUS-RFA) for pancreatic cysts has been studied for safety, with research indicating it is generally safe, though some risks of adverse events exist. A large French study found it to be a potentially safe option for treating pancreatic neoplasms (abnormal tissue growths), but like any medical procedure, there are risks involved. ^{4 5 6 7 8}

How is EUS-guided RFA treatment for pancreatic cysts different from other treatments?

EUS-guided RFA (radiofrequency ablation) for pancreatic cysts is unique because it is a minimally invasive procedure that uses heat to destroy cyst tissue, unlike traditional surgery which involves removing part of the pancreas and carries higher risks. This treatment is performed using an endoscopic ultrasound to guide a needle to the cyst, offering a less invasive option with potentially fewer complications. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Long-term follow-up of pancreatic cysts that resolve radiologically after EUS-guided ethanol ablation. [2022]

2. China pubmed.ncbi.nlm.nih.gov

Thermal ablation of pancreatic cyst with a prototype endoscopic ultrasound capable radiofrequency needle device: A pilot feasibility study. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Pancreatic Cysts after Endoscopic Ultrasonography-Guided Ethanol and/or Paclitaxel Ablation Therapy: Another Mimic of Pancreatic Pseudocysts. [2022]

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

Systemic effect of endoscopic ultrasonography-guided pancreatic cyst ablation with ethanol and paclitaxel. [2021]

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

Endoscopic ultrasound-guided ablation therapy for pancreatic cysts. [2020]

6. United States 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. [2022]

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

EUS-guided fine needle aspiration of pancreatic cysts: a retrospective analysis of complications and their predictors. [2022]

8. 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]