NCT03784417

EUS-guided Laser Ablation in Pancreatic Adenocarcinoma

EUS-guided Laser Complete Ablation of Advanced Pancreatic Ductal Adenocarcinoma: a Feasibility Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the possibility of performing local therapy for PDAC using laser ablation of the tumor under ultrasonography (EUS) guidance. Safety of the procedure as well as post procedural quality of life will be also evaluated.

Detailed description

Pancreatic adenocarcinoma (PDAC) is projected to be the second cause of cancer death in Western societies within a decade. Management include chemotherapy and/or radiation therapy, while resectable disease is possible only in 15% of cases. Despite these therapeutic approaches, the survival rate of unresectable pancreatic cancer remains disappointing. Recently, there is a growing interest in the development of alternative therapeutic approaches, which can work in parallel with standard chemoradiation therapy. These methods include intra-lesion injection/instillation of antitumoral agents performed through a laparoscopic approach, or percutaneously or under endoscopic ultrasound (EUS) guidance and tumor volume reduction procedures using ablative techniques. In this context laser ablation has been reported to be effective in inducing coagulative necrosis of the tumour in absence of major adverse events. However, the available studies on the matter are limited by small sample size, lack of extended follow up and informations about the possibility to ablate the entire tumour mass.

Conditions

• Pancreatic Adenocarcinoma
• Pancreas Cancer

Interventions

Type	Name	Description
DEVICE	EUS-guided laser ablation	EUS-guided LA will be performed with an endoscopic ultrasound guided approach using a 1064-nm wavelength laser with the insertion of a 300-μm optical fiber through a 22-gauge flexible needle that is inserted in the working channel of the echoendoscope.

Timeline

• Start date: 2019-10-15
• Primary completion: 2021-12-15
• Completion: 2021-12-15
• First posted: 2018-12-21
• Last updated: 2022-02-28

Locations

2 sites across 1 country: Italy