Clinical trial NCT03772756: EUS-RFA for Unresectable Pancreatic Ductal Adenocarcinoma
Official title: Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Unresectable Pancreatic Adenocarcinoma - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Adenocarcinoma Non-resectable
Keywords: pancreatic adenocarcinoma
radiofrequency ablation
Endoscopic ultrasound
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Change in tumour size as measured on EUS and or CT
timeFrame: 60 days
measure: Change in serum levels of Ca 19-9
timeFrame: 60 days
Secondary outcomes:
measure: Overall survival at 6 months
timeFrame: 6 months
measure: Overall survival at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Jianfeng Yang
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
Study officials:
affiliation: First People's Hospital of Hangzhou
name: Xiaofeng Zhang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.