EUS-RFA for Unresectable Pancreatic Ductal Adenocarcinoma

Zhejiang University

Status: Completed

Conditions: Pancreatic Adenocarcinoma Non-resectable

Treatments: Radiation: chemoradiotherapy; Procedure: Endoscopic ultrasound guided radiofrequency ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03772756

2018-139-01

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 38 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

EUS-RFA group

Experimental group

Description:

Patients in EUS-RFA group will undergo endoscopic ultrasound guided radiofrequency ablation(EUS-RFA ) and chemoradiotherapy

Treatment:

Procedure: Endoscopic ultrasound guided radiofrequency ablation

Radiation: chemoradiotherapy

control group

Active Comparator group

Description:

the control group will receive chemoradiotherapy only

Treatment:

Radiation: chemoradiotherapy