35 Participants NeededMy employer runs this trial

Endoscopic Ultrasound-Guided Chemoablation for Pancreatic Cysts

(ERASE-Chemo Trial)

TO
Overseen ByThe Ohio State University Comprehensive Cancer Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment method for individuals with pancreatic cysts, which can potentially lead to pancreatic cancer. The treatment uses an endoscope (a thin tube with a camera) to deliver chemotherapy drugs, specifically Gemcitabine Hydrochloride and Paclitaxel, directly into the cyst. This aims to destroy abnormal cells while minimizing impact on the rest of the body. Individuals diagnosed with a pancreatic cyst who cannot undergo surgery might be suitable candidates for this trial. This approach could provide a less invasive option for managing these cysts. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of potentially effective therapies.

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 this endoscopic ultrasound-guided chemoablation is safe for treating pancreatic cysts?

Research has shown that EUS-guided chemoablation using gemcitabine and paclitaxel is generally safe for treating pancreatic cysts. One study found that 67% of patients had their cysts completely removed 12 months after treatment. Additionally, long-term results indicated that 87% of patients remained cyst-free for three to five years.

Gemcitabine has proven effective in destroying tumor cells and is considered safe in this procedure. Similarly, paclitaxel is safe for comparable treatments, yielding good results with few serious side effects.

These findings suggest that the treatment is generally well-tolerated, with few negative effects reported. However, as with any medical procedure, risks exist, so discussing these with a doctor is important.12345

Why do researchers think this study treatment might be promising?

Unlike the standard care for pancreatic cysts, which often involves surgical removal or monitoring, the endoscopic ultrasound-guided chemoablation with gemcitabine and paclitaxel offers a minimally invasive approach. Researchers are excited about this treatment because it directly targets the cysts via chemoablation, potentially reducing the need for surgery and its associated risks. This method combines the precision of endoscopic ultrasound with potent anticancer agents delivered directly to the site, which could lead to more effective cyst management and better patient outcomes.

What evidence suggests that EUS-guided chemoablation might be an effective treatment for pancreatic cysts?

Research has shown that endoscopic ultrasound (EUS)-guided chemoablation, using gemcitabine and paclitaxel, holds promise for treating pancreatic cysts. In this trial, participants will undergo EUS-guided chemoablation with these drugs. Studies have found that this method can make the cysts disappear or shrink significantly. Patients receiving this treatment often require fewer medical check-ups, and the cysts are less likely to return or become cancerous. EUS-guided chemoablation is considered safe and effective, offering a less invasive alternative to surgery for managing pancreatic cysts. By delivering gemcitabine and paclitaxel directly into the cysts, this approach targets and kills abnormal cells while minimizing side effects on the rest of the body.12678

Who Is on the Research Team?

SG

Somashekar G Krishna, MD, MPH

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with pancreatic cysts confirmed by specialized imaging and biopsy, who are not candidates for surgery due to age, other health problems (like liver disease or heart/lung issues), or personal choice. Cysts must be at least 1 cm in size.

Inclusion Criteria

I have chosen not to have surgery for my condition.
I have a pancreatic cyst and did not fully respond to previous ablation treatments.
I am not eligible for surgery to treat my condition.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Patients undergo EUS-guided fine needle aspiration and chemoablation with gemcitabine and paclitaxel via intracystic fine needle injection on day 0

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with imaging and possible EUS with or without FNA as clinically indicated

3 years
Every 3-6 or 6-12 months as per standard of care

What Are the Treatments Tested in This Trial?

Interventions

  • Gemcitabine Hydrochloride
  • Paclitaxel

Trial Overview

The study tests a minimally invasive procedure where chemotherapy drugs (gemcitabine and paclitaxel) are injected directly into pancreatic cysts using an endoscope guided by ultrasound. The goal is to destroy abnormal cells while limiting effects on the rest of the body.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)Experimental Treatment10 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

Citations

EUS-Guided Ablation Techniques for Pancreatic Lesions

This review aims to summarize current practices and future directions of EUS-guided ablation for both pancreatic cysts and tumors.

EUS-guided ablation for pancreatic cystic lesions - PMC - NIH

EUS-guided ablation represents an innovative and promising minimally invasive treatment for selected PCL patients, including EUS-guided ...

Endoscopic Ultrasound-Guided Chemoablation for the ...

This phase II trial tests the effect of endoscopic ultrasound (EUS)-guided chemoablation in treating patients with pancreatic cysts.

A Systematic Review and Meta-Analysis

CONCLUSION: The treatment of pancreatic cysts with endoscopic ultrasound ablation results in acceptable levels of complete resolution, and low ...

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.

Endoscopic Ultrasound-Guided Chemoablation for ...

This phase II trial tests the effect of endoscopic ultrasound (EUS)-guided chemoablation in treating patients with pancreatic cysts.

The Safety and Efficacy of an Alcohol-Free Pancreatic Cyst ...

RESULTS: At. 12 months, 67% of patients who underwent alcohol-free EUS- guided cyst chemoablation had complete ablation of cysts compared with 61% of patients ...

Successful EUS-guided pancreatic cyst chemoablation ...

Background and Aims: Endoscopic ultrasound–guided pancreatic cyst chemoablation is safe and effective for appropriately selected patients; however, ...