Status:
TERMINATED
EUS-guided Laser Ablation in Pancreatic Adenocarcinoma
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Pancreatic Adenocarcinoma
Pancreas Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
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 qu...
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 di...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03784417
Start Date
October 15 2019
End Date
December 15 2021
Last Update
February 28 2022
Active Locations (2)
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1
Fondazione Policlinico Universitario Agostino Gemelli
Roma, RM, Italy, 00168
2
Universita' Cattolica del Sacro Cuore
Rome, Italy, 00136