EUS-RFA for Unresectable Pancreatic Ductal Adenocarcinoma

NCT ID: NCT03772756

Last Updated: 2021-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-20
• Study Completion Date: 2021-08-16

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 .

Conditions

Pancreatic Adenocarcinoma Non-resectable

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EUS-RFA group

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

Group Type: EXPERIMENTAL

Endoscopic ultrasound guided radiofrequency ablation

Intervention Type: PROCEDURE

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.

chemoradiotherapy

Intervention Type: RADIATION

Receive chemoradiotherapy

control group

the control group will receive chemoradiotherapy only

Group Type: ACTIVE_COMPARATOR

chemoradiotherapy

Intervention Type: RADIATION

Receive chemoradiotherapy

Interventions

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.

Intervention Type: PROCEDURE

chemoradiotherapy

Receive chemoradiotherapy

Intervention Type: RADIATION

Other Intervention Names

EUS-RFA

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First People's Hospital of Hangzhou

OTHER

Sponsor Role: lead

Responsible Party

Jianfeng Yang

Associate director of gastroenterology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaofeng Zhang

Role: PRINCIPAL_INVESTIGATOR

First People's Hospital of Hangzhou

Locations

Jianfeng Yang

Hangzhou, Zhejiang, China

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 23049547 (View on PubMed)

Other Identifiers

2018-139-01

Identifier Type: -

Identifier Source: org_study_id