EUS-RFA for Unresectable Pancreatic Cancer

Study Overview
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Brief Summary
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The clinical application of intraoperative or percutaneous radiofrequency ablation (RFA) for pancreatic ductal adenocarcinoma (PDAC) is limited due to higher mortality and incidence of adverse events. The aim of this study was to evaluate the efficacy and safety of endoscopic ultrasonography-guided RFA (EUS-RFA) for locally advanced, unresectable PDAC. Patients with unresectable PDAC who underwent EUS-RFA were included from September 2013 to June 2016. Pre- and post-procedural clinical data was retrospective collected.

Detailed Description
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evaluate the efficacy and safety of endoscopic ultrasonography-guided RFA (EUS-RFA) for locally advanced, unresectable PDAC.

Official Title
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Efficacy and Safety of Endoscopic Ultrasonography-guided Radiofrequency Ablation in Treatment of Locally Advanced, Unresectable Pancreatic Cancer

Conditions
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Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Procedure: EUS-RFA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 20 to 80 years old. ② unresectable PDAC based on review of abdominal cross-sectional imaging (CT or MRI) and cytology/ histology results. ③Intolerance to chemotherapy due to side effects or patient's comorbidities. Exclusion Criteria: Pregnancy or breast-feeding；②ECOG performance status 3 or 4；③Patients with distant metastases or malignant ascites, life expectancy less than 3 months.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EUS-RFA<br>Patients were placed in the lateral position under deep sedation with supplementary oxygen and electrocardiograph monitoring. The target tumor was identified by EUS, then the biopsy needle stylet was removed and replace with the RFA probe. RF energy was applied for 90-120 seconds at 5 Watts. Wait 1 minute before repositioning the Habib™ EUS RFA needle and repeat procedure as many times as needed to ensure complete ablation of the tumor. EUS-guided celiac plexus neurolysis (EUS-CPN) was performed on patients with intractable upper abdominal pain. | Procedure: EUS-RFA<br>* Use EUS-RFA to treat unresectable pancreatic cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor size | Tumor size | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of CA19-9 | Serum levels of CA19-9 before and after surgery | 2 years | 
| survival rate | including Overall survival | 2 years | 
| Adverse events | Adverse events | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic ductal adenocarcinoma, Unresectable pancreatic cancer, Radiofrequency ablation, Endoscopic ultrasound