EUS-guided Laser Ablation in Pancreatic Adenocarcinoma

Catholic University of the Sacred Heart

Status: Terminated

Conditions: Pancreatic Adenocarcinoma; Pancreas Cancer

Treatments: Device: EUS-guided laser ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03784417

EUS-LASER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

EUS-guided laser ablation

Experimental group

Description:

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.

Treatment:

Device: EUS-guided laser ablation