Overview

A Clinical Study of EUS-RFA for Inoperable Pancreatic Ductal Adenocarcinoma

Status:
Not yet recruiting
Trial end date:
2022-01-01
Target enrollment:
108
Participant gender:
All
Summary
To assess if endoscopic ultrasound-guided radiofrequency ablation application in patients with inoperable pancreatic cancer confers survival benefit when compared to patients receiving standard medical care.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Criteria
Inclusion Criteria:

- Patients above 18 years of age.

- A cytological / histological diagnosis of inoperable PDAC based on multidisciplinary
review of cross-sectional imaging and cytology / histology results.

- Patients ought to be fit enough to be considered for the study (ECOG performance
status 0, 1 or 2)

- Patients who have commenced chemotherapy are not excluded from the study

- Patients capable of giving informed consent

- Negative blood pregnancy test for women of childbearing potential

- Willingness and ability to comply with all protocol requirements including scheduled
visits, treatment plans, laboratory tests and other study procedures.

Exclusion Criteria:

- ECOG performance status 3 or 4

- Life expectancy less than 3 months (including liver metastases, carcinomatosis)

- Prior investigational drugs within the last 30 days

- Known infection with human immunodeficiency virus (HIV)