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

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Phase II Prospective Randomised Clinical Study of Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Inoperable Pancreatic Ductal Adenocarcinoma

Conditions
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Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Device: EUS-RFA using Habib Tm as a probe
* Procedure: EUS


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 radiofrequency ablation procedures<br>Subject will undergo 3 radiofrequency ablation procedures at 1 month intervals (EUS-RFA using Habib Tm as a probe) | Device: EUS-RFA using Habib Tm as a probe<br>* 3 EUS-RFA interventions at 1-month interval<br>|
| Active Comparator: standard medical care<br>Subject will receive standard medical care, including pain relief drugs | Procedure: EUS<br>* Standard intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Duration of survival | 1 month | 
| Survival | Duration of survival | at time of death on average 10months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES) | Quality of life questionnaire DDQ15 | 1 month | 
| Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES) | Quality of life questionnaire DDQ15 | Time of death on average 10 months | 
| Pain reduction | Likert Scale | 1 month | 
| Pain reduction | Likert Scale | Time of death on average 10months | 
| Tumour Size | Measures during follow-upEUS | 4 months | 
| Monitoring of Adverse reactions | Number of participants with treatment-related adverse events will be recorded | At time of death on average 10months |