CLINICAL TRIAL Pre-planning Mathematical Models in EUS-guided Laser Ablation of Pancreatic Lesions (LA-EUS MOD):
Pancreatic ductal adenocarcinoma (PDAC) is the fourth cause of cancer death in Western countries. More than 50% of the patients with PDAC has a local advanced or metastatic disease at the time of the diagnosis. There is a growing interest in the investigation of novel and alternative therapeutic strategies which could be used in synergy with radiotherapy and chemotherapy. These methods include echoendoscopic (EUS) guided locoregional ablation to reduce the tumoral mass.
Laser Ablation is the only ablative technique that allows the use of a thin needle, hence reducing the patient’s discomfort and obtaining a procedure which is less operator-dependent. These features make Laser Ablation a suitable option for treating focal lesions in high-risk areas or in hard-to-reach locations.
In order to perform a study aimed at the complete treatment of the lesion, it is necessary to identify the laser parameters which are specific to the size and location of the lesion.
The present protocol presents a prospective interventional study aimed at the analysis and applicability of predictive mathematical models for the calculation of the optimized and patient-specific laser settings in the ablation of pancreatic lesion by means of a EUS-guided laser procedure.
Details of the phase I clinical trial of the LASER OPTIMAL Project study are available in the public registry clinicaltrials.gov, with the number NCT05549960.
https://clinicaltrials.gov/ct2/show/NCT05549960?term=NCT05549960&draw=2&rank=1
The patient’s recruitment is currently ongoing at Operative Digestive Endoscopy Unit, Campus Bio-Medico University Hospital Foundation.