EUS-RFA for Unresectable Pancreatic Ductal Adenocarcinoma

Not Applicable

Completed

• Conditions: Pancreatic Adenocarcinoma Non-resectable
• Interventions: Radiation: chemoradiotherapy; Procedure: Endoscopic ultrasound guided radiofrequency ablation

• Registration Number: NCT03772756
• Lead Sponsor: First People's Hospital of Hangzhou

Brief Summary

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

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 .

Study Timeline

• Study First Submitted: 2018-12-09
• Study First Submitted QC: 2018-12-09
• Study First Posted: 2018-12-11
• Study Start: 2018-12-20
• Status Verified: 2021-08
• Primary Completion: 2021-08-16
• Study Completion: 2021-08-16
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	chemoradiotherapy	the control group will receive chemoradiotherapy only
EUS-RFA group	chemoradiotherapy	Patients in EUS-RFA group will undergo endoscopic ultrasound guided radiofrequency ablation(EUS-RFA ) and chemoradiotherapy
EUS-RFA group	Endoscopic ultrasound guided radiofrequency ablation	Patients in EUS-RFA group will undergo endoscopic ultrasound guided radiofrequency ablation(EUS-RFA ) and chemoradiotherapy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall survival at 12 months	12 months	Survival rate 12 months after EUS-RFA
Overall survival at 6 months	6 months	Survival rate 6 months after EUS-RFA

Trial Locations

Locations (2)

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

Jianfeng Yang; 🇨🇳 Hangzhou, Zhejiang, China