EUS-Guided Cryothermal Ablation in Patients With Stage III Pancreatic Adenocarcinoma (HybridTherm Study)

NACompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

November 11, 2014

Primary Completion Date

December 31, 2018

Study Completion Date

December 31, 2021

Conditions
Pancreatic Adenocarcinoma Non-resectable
Interventions
DEVICE

Cryothermal ablation

Procedures are performed with patients sedated by anaesthesiologists. Device setting and application time are set and recorded on a computer, that analyzes the changes of the tissue's properties. The setting of the maximal application time is based on the results of our previously described ex-vivo and in-vivo studies and is adjusted to the tumour's size, thus ensuring a reduction of procedure-related complications. Application of Power Doppler makes the procedure safer. The HybridTherm probe is guided under real-time EUS into the tumour, and the success of its placement is an index of the treatment's feasibility. The system analyzes the effects on the tissue and EUS records the changes of the tissue, the growing edema around the treated area, and the tissue devitalization.

Trial Locations (1)

20132

Ospedale San Raffaele Irccs, Milan

All Listed Sponsors
lead

IRCCS San Raffaele

OTHER

NCT02336672 - EUS-Guided Cryothermal Ablation in Patients With Stage III Pancreatic Adenocarcinoma (HybridTherm Study) | Biotech Hunter | Biotech Hunter