EUS-RFA for Unresectable Pancreatic Ductal Adenocarcinoma

Pancreatic Adenocarcinoma Non-resectable Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03772756
• Other study ID #: 2018-139-01
• Status: Completed
• Phase: N/A
• Start date: December 20, 2018
• Est. completion date: August 16, 2021

Study information

• Verified date: August 2021
• Source: First People's Hospital of Hangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 16, 2021
• Est. primary completion date: August 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma Non-resectable

Intervention

Procedure:
• Endoscopic ultrasound guided radiofrequency ablation
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.

Radiation:
• chemoradiotherapy
Receive chemoradiotherapy

Locations

Country	Name	City	State
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang
China	Jianfeng Yang	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

References & Publications (1)

Gaidhane M, Smith I, Ellen K, Gatesman J, Habib N, Foley P, Moskaluk C, Kahaleh M. Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA) of the Pancreas in a Porcine Model. Gastroenterol Res Pract. 2012;2012:431451. doi: 10.1155/2012/431451. Epub 2012 Sep 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Overall survival at 6 months	Survival rate 6 months after EUS-RFA	6 months
Secondary	Overall survival at 12 months	Survival rate 12 months after EUS-RFA	12 months