EUS-RFA for Unresectable Pancreatic Cancer

Not Applicable

Completed

• Conditions: Pancreatic Ductal Adenocarcinoma
• Interventions: Procedure: EUS-RFA

• Registration Number: NCT04310111
• Lead Sponsor: First People's Hospital of Hangzhou

Brief Summary

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

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

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-15
• Study First Posted: 2020-03-17
• Primary Completion: 2021-07-25
• Status Verified: 2021-08
• Study Completion: 2021-08-25
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EUS-RFA	EUS-RFA	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.

Primary Outcome Measures

Name	Time	Method
Tumor size	2 years	Tumor size

Secondary Outcome Measures

Name	Time	Method
Serum levels of CA19-9	2 years	Serum levels of CA19-9 before and after surgery
Adverse events	2 years	Adverse events
survival rate	2 years	including Overall survival

Trial Locations

Locations (1)

Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China