Clinical trial NCT03784417: EUS-guided Laser Ablation in Pancreatic Adenocarcinoma
Official title: EUS-guided Laser Complete Ablation of Advanced Pancreatic Ductal Adenocarcinoma: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pancreatic Adenocarcinoma
Pancreas Cancer
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tumor necrosis induction by EUS-guided laser ablation (LA) - Number of patients with necrosis of the tumor
timeFrame: at 1 month from the intervention
Secondary outcomes:
measure: Incidence of early and late adverse events after EUS-guided laser ablation (LA)
timeFrame: at 7 days and 3 months from the intervention
measure: Disease response to EUS-guided laser ablation (LA)
timeFrame: From date of treatment, every 4 months, assessed until death or up to 2 years
measure: Post-procedural quality of life
timeFrame: From date of enrollment (baseline), every 2 months, assessed until death or up to 2 years
measure: Progression-free-survival (PFS)
timeFrame: From date of enrollment assessed until death or up to 2 years
measure: Overall survival
timeFrame: From date of enrollment assessed until death or up to 2 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
state: RM
city: Rome
country: Italy
facility: Universita' Cattolica del Sacro Cuore
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli
name: Alberto Larghi, PhD
role: PRINCIPAL_INVESTIGATOR
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