Non-Invasive Pancreas Ablation Using Histotripsy: Pre-clinical Safety Study in an In Vivo Porcine Model.

Area of Science:

• Medical Engineering
• Oncology
• Gastroenterology

Background:

• Pancreatic cancer has a poor prognosis due to late diagnosis.
• Current treatments have limited efficacy, with a 5-year survival rate of 12.5%.
• Histotripsy, an FDA-approved focused ultrasound therapy for liver tumors, is being explored for other applications.

Purpose of the Study:

• To investigate the feasibility of pancreas ablation using ultrasound-guided histotripsy in a porcine model.
• To assess the safety and efficacy of histotripsy for pancreatic tissue ablation.

Main Methods:

• Nine pigs underwent ultrasound-guided histotripsy targeting the pancreas.
• Treatments were guided by real-time ultrasound imaging.
• Post-procedure analysis included gross morphology, histology, and CT imaging at 1 and 5 weeks.

Main Results:

• Histotripsy successfully targeted the pancreas in 6 out of 9 subjects.
• Lesion dimensions were consistent with the planned treatment volume.
• Observed lesion size reduction at 5 weeks ranged from 49% to 100% in three subjects.
• Histotripsy was generally well-tolerated, with two cases of potential pancreatitis.
• Three pigs experienced bowel damage due to poor ultrasound visualization, leading to off-target effects.

Conclusions:

• Ultrasound-guided histotripsy is a viable approach for pancreatic treatment.
• Clear visualization of the pancreas during treatment is crucial for safety and efficacy.
• Further research is needed to optimize targeting and minimize off-target effects.