EUS-RFA for Unresectable Pancreatic Ductal Adenocarcinoma

Study Overview
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Brief Summary
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the study evaluate the efficacy and safety of EUS-RFA using Habib EUS-RFA catheter with a prospective randomised trial in patients with inoperable PDAC.

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 ablation (RFA) has been developed in our unit and used in patients with unresectable bile duct and pancreatic head adenocarcinomas presenting with biliary obstruction. Various techniques of EUS-guided tumour ablation have been described, including RF ablation, photodynamic therapy, laser ablation, and ethanol injection. Endoscopic ultrasound guided RFA (EUS-RFA) of the pancreatic head using Habib EUS-RFA catheter through a 19-gauge needle was well tolerated in 5 Yucatan pigs and with minimum amount of pancreatitis .

Official Title
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Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Unresectable Pancreatic Adenocarcinoma - a Randomised Controlled Trial

Conditions
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Pancreatic Adenocarcinoma Non-resectable

Intervention / Treatment
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* Procedure: Endoscopic ultrasound guided radiofrequency ablation
* Radiation: chemoradiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in the age group 20 to 80 years A cytological or histological diagnosis of inoperable PDAC based on multidisciplinary review of cross sectional imaging and cytology or histology results. Patients who have been deemed unfit for surgical resection of the PDAC subjects who are fit for surgical resection but have declined surgery will also be considered for the study PDAC patients presenting with jaundice to be considered after a successful biliary drainage Patients ought to be fit enough to be considered for the study (ECOG performance status 0, 1 or 2) Patients capable of giving informed consent Exclusion Criteria: Inability to give informed consent Pregnancy or breast feeding ECOG performance status 3 or 4 Life expectancy less than 3 months Patients with distant metastases or malignant ascites

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EUS-RFA group<br>Patients in EUS-RFA group will undergo endoscopic ultrasound guided radiofrequency ablation(EUS-RFA ) and chemoradiotherapy | Procedure: Endoscopic ultrasound guided radiofrequency ablation<br>* Endoscopic ultrasound guided radiofrequency ablation （EUS-RFA） will be done in 3 different sessions with 2 weeks interval between each session on Day 1, Day 15 and Day 30. Each session will involve multiple applications of EUS-RFA (up to 10) with RF setting of 25 Watts over 90 seconds for each application.<br>* Other names: EUS-RFA;Radiation: chemoradiotherapy<br>* Receive chemoradiotherapy<br>|
| Active Comparator: control group<br>the control group will receive chemoradiotherapy only | Radiation: chemoradiotherapy<br>* Receive chemoradiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tumour size as measured on EUS and or CT | The tumor size was compared before and after 60 days EUS-RFA | 60 days | 
| Change in serum levels of Ca 19-9 | Serum levels of Ca 19-9 was compared before and after 60 days EUS-RFA | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival at 6 months | Survival rate 6 months after EUS-RFA | 6 months | 
| Overall survival at 12 months | Survival rate 12 months after EUS-RFA | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic adenocarcinoma, radiofrequency ablation, Endoscopic ultrasound