EUS-RFA for Unresectable Pancreatic Ductal Adenocarcinoma

August 27, 2021 updated by: Jianfeng Yang, First People's Hospital of Hangzhou

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 31006
        • Hangzhou First People's Hospital
      • Hangzhou, Zhejiang, China, 310006
        • Jianfeng Yang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EUS-RFA group
Patients in EUS-RFA group will undergo endoscopic ultrasound guided radiofrequency ablation(EUS-RFA ) and chemoradiotherapy
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.
Other Names:
  • EUS-RFA
Radiation: chemoradiotherapy
Receive chemoradiotherapy
ACTIVE_COMPARATOR: control group
the control group will receive chemoradiotherapy only
Radiation: chemoradiotherapy
Receive chemoradiotherapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival at 6 months
Time Frame: 6 months
Survival rate 6 months after EUS-RFA
6 months
Overall survival at 12 months
Time Frame: 12 months
Survival rate 12 months after EUS-RFA
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First People's Hospital of Hangzhou

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 20, 2018

Primary Completion (ACTUAL)

August 16, 2021

Study Completion (ACTUAL)

August 16, 2021

Study Registration Dates

First Submitted

December 9, 2018

First Submitted That Met QC Criteria

December 9, 2018

First Posted (ACTUAL)

December 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 27, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-139-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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