Pancreatic Ductal Adenocarcinoma
Conditions
Brief 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.
Detailed description
The five-year survival for pancreatic ductal adenocarcinoma (PDAC) is less than 5% in spite of the advances in management of cancers in the last few decades. Endobiliary application of radiofrequency (RF) has been developed and used in patients with inoperable bile duct and pancreatic head adenocarcinomas presenting with biliary obstruction. (1, 2) Endoscopic ultrasound (EUS) radiofrequency ablation (RFA) of pancreatic neoplasms has been proven to be well tolerated and safe, inducing a significant reduction in tumour size (3). Various techniques of EUS-guided tumour ablation have been described, including RF ablation, photodynamic therapy, laser ablation, and ethanol injection (4). Kahaleh et al. have demonstrated that Endoscopic ultrasound guided RF ablation (EUS-RFA) of the pancreatic head using Habib EUS-RFA catheter (EMcision Ltd, UK) through a 19-gauge needle was well tolerated in 5 Yucatan pigs and with minimum amount of pancreatitis (5). In a pilot clinical study, Pai et al showed either a complete response or at least a 50% reduction in tumours following application of radiofrequency ablation with the Habib™ EUS-RFA device in a group of eight patients with pancreatic cancers (3).
Interventions
DEVICEEUS-RFA using Habib Tm as a probe
3 EUS-RFA interventions at 1-month interval
PROCEDUREEUS
Standard intervention
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 (Eastern Cooperative Oncology Group) 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 1 month | Duration of survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES) | 1 month | Quality of life questionnaire DDQ15 |
| Pain reduction | 1 month | Likert Scale |
| Tumour Size | 4 months | Measures during follow-upEUS |
| Monitoring of Adverse reactions | At time of death on average 10months | Number of participants with treatment-related adverse events will be recorded |
Countries
Canada
Outcome results
None listed