EUS-guided Laser Complete Ablation of Advanced Pancreatic Ductal Adenocarcinoma: a Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Tumor necrosis induction by EUS-guided laser ablation (LA) - Number of patients with necrosis of the tumor
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histological diagnosis of pancreatic ductal adenocarcinoma
- •Unresectable advanced, non-metastatic Stage III tumor
- •Stable disease without regression or progression after 6 months of chemotherapeutic treatment
- •Locally progressive disease after chemiotherapy, without evidence of metastases
- •Age >18 and <80 years
- •Willing to be followed up c/o the Fondazione Policlinico A. Gemelli University Hospital
- •Signed informed consent
Exclusion Criteria
- •Stage I, Stage II, Stage IV disease
- •Absolute contraindications to general anesthesia or deep sedation
- •Absolute contraindications to perform digestive endoscopy
- •Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)
- •Use of anticoagulants that cannot be discontinued
- •International Normalized Ratio (INR) >1.5 or platelet count <50.000
- •Pregnancy or lactation
- •Unable to sigh informed consent
Arms & Interventions
EUS-guided laser ablation
Laser ablation will be performed using a 1064-nm wavelength laser with the insertion of a 300-μm optical fiber through a 22-gauge needle under endoscopic ultrasonography guidance.
Intervention: EUS-guided laser ablation (Device)
Outcomes
Primary Outcomes
Tumor necrosis induction by EUS-guided laser ablation (LA) - Number of patients with necrosis of the tumor
Time Frame: at 1 month from the intervention
Number of patients with necrosis of the tumor, as demonstrated by the involution of the pancreatic mass on CT scan performed after one month from the treatment
Secondary Outcomes
- Incidence of early and late adverse events after EUS-guided laser ablation (LA)(at 7 days and 3 months from the intervention)
- Disease response to EUS-guided laser ablation (LA)(From date of treatment, every 4 months, assessed until death or up to 2 years)
- Post-procedural quality of life(From date of enrollment (baseline), every 2 months, assessed until death or up to 2 years)
- Progression-free-survival (PFS)(From date of enrollment assessed until death or up to 2 years)
- Overall survival(From date of enrollment assessed until death or up to 2 years)
Investigators
Guido Costamagna
Professor
Catholic University of the Sacred Heart