EUS-guided Laser Ablation in Pancreatic Adenocarcinoma
- Conditions
- Pancreas CancerPancreatic Adenocarcinoma
- Interventions
- Device: EUS-guided laser ablation
- Registration Number
- NCT03784417
- Lead Sponsor
- Catholic University of the Sacred Heart
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EUS-guided laser ablation 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.
- Primary Outcome Measures
Name Time Method Tumor necrosis induction by EUS-guided laser ablation (LA) - Number of patients with necrosis of the tumor 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 Outcome Measures
Name Time Method Incidence of early and late adverse events after EUS-guided laser ablation (LA) at 7 days and 3 months from the intervention Percentage of early and late adverse events. Early adverse events will be those occurring during the procedure up to the first week after the ablation treatment. Late adverse events will be defined as any adverse event potentially related to the procedure occurring at the site of the primary tumor within 3 months after EUS LA treatment. Adverse events will be considered major if they prevent completion of the scheduled procedure and/or resulted in prolongation of hospital stay, another therapeutic procedure (needing sedation/anesthesia), or subsequent medical consultation. Any potential adverse event such as pancreatitis, burns of the gastric or duodenal walls, bowel injury, or peritonitis will be recorded and graded according to the above-mentioned classification.
Disease response to EUS-guided laser ablation (LA) From date of treatment, every 4 months, assessed until death or up to 2 years Correlation between RNA markers evaluated by TaqMan RNA assay in serum and treatment response
Post-procedural quality of life From date of enrollment (baseline), every 2 months, assessed until death or up to 2 years Change from baseline in quality of life (QOL) scores after treatment evaluated by using the European Organization for Research and Treatment core quality of life questionnaire (EORTC QLQ-C30), version 3.0. EORTC QLQ-C30 questionnaire evaluates 5 functions physical,role,cognitive, emotional, and social), 9 symptoms (fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation, diarrhea, and financial difficulties) and the global health status. Questions regarding functions and symptoms are scored 1 to 4, with higher values representing a worse outcomes. Questions regarding global health status are scored 1 to 7, with higher values representing better outcomes.
Progression-free-survival (PFS) From date of enrollment assessed until death or up to 2 years PFS defined as the time from the date of trial entry until disease progression or relapse.
Overall survival From date of enrollment assessed until death or up to 2 years Overall survival defined as the length of time (in days) between the treatment date and the date of death.
Trial Locations
- Locations (2)
Fondazione Policlinico Universitario Agostino Gemelli
🇮🇹Roma, RM, Italy
Universita' Cattolica del Sacro Cuore
🇮🇹Rome, Italy