Endoscopic Ultrasound-Guided Chemoablation for the Treatment of Pancreatic Cystic Neoplasms

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center

About this trial

This phase II trial tests the effect of endoscopic ultrasound (EUS)-guided chemoablation in treating patients with pancreatic cysts. 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%. Pancreatic cysts are a common precancerous lesion that may develop into pancreatic cancer. An EUS is a procedure in which an endoscope is inserted into the body. An endoscope is a thin, tube-like instrument that has a light and a lens for viewing. A probe at the end of the endoscope is used to bounce high-energy sound waves (ultrasound) off internal organs to make a picture (sonogram). EUS-guided chemoablation uses a fine needle inserted into the pancreatic cyst to deliver chemotherapy, such as gemcitabine and paclitaxel, directly into the cyst ("intracystic"). Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. An EUS-guided chemoablation, with gemcitabine and paclitaxel, may be an effective minimally invasive strategy to destroy abnormal or precancerous cells while reducing exposure to the rest of the body in patients with pancreatic cysts.

Eligibility criteria

Qualifiers

Age > 18 years

A diagnosis of a pancreatic cystic neoplasm (PCN) confirmed by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) including cyst fluid next-generation sequencing (NGS) and/or EUS-needle based confocal laser endomicroscopy (nCLE) and/or EUS-through the needle biopsy (TTNB)

The pancreatic cystic lesion (PCL) measures at least 1 cm in diameter on CT, MRI/MRCP, or EUS

This cohort may include patients with PCNs previously treated with other ablative modalities include EUS-radiofrequency ablation (RFA) (NCT05961982, institutional review board [IRB]: 2023C0004) or EUS-pulsed electric field (PEF) (IRB 20251089) who have shown either no response or only a partial response to therapy

Disqualifiers

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

Any psychiatric disorder making reliable informed consent impossible

Pregnancy or breast-feeding

Pregnant patients will be excluded due to confounding variables

Trial design

Treatments tested in this trial

  • Ablation Therapy
  • Biospecimen Collection
  • Computed Tomography
  • Electronic Health Record Review
  • Endoscopic Ultrasound
  • Endoscopic Ultrasound-Guided Fine-Needle Aspiration
  • Gemcitabine Hydrochloride
  • Magnetic Resonance Cholangiopancreatography
  • Magnetic Resonance Imaging
  • Paclitaxel

Treatment groups

35 Participants
are divided into 1 treatment group