Back to resultsEUS-RFA for Unresectable Pancreatic Ductal Adenocarcinoma
Primary Purpose
Pancreatic Adenocarcinoma Non-resectable
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endoscopic ultrasound guided radiofrequency ablation
chemoradiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Adenocarcinoma Non-resectable focused on measuring pancreatic adenocarcinoma, radiofrequency ablation, Endoscopic ultrasound
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
Sites / Locations
- Jianfeng Yang
- Hangzhou First People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EUS-RFA group
control group
Arm Description
Patients in EUS-RFA group will undergo endoscopic ultrasound guided radiofrequency ablation(EUS-RFA ) and chemoradiotherapy
the control group will receive chemoradiotherapy only
Outcomes
Primary Outcome Measures
Change in tumour size as measured on EUS and or CT
The tumor size was compared before and after 60 days EUS-RFA
Change in serum levels of Ca 19-9
Serum levels of Ca 19-9 was compared before and after 60 days EUS-RFA
Secondary Outcome Measures
Overall survival at 6 months
Survival rate 6 months after EUS-RFA
Overall survival at 12 months
Survival rate 12 months after EUS-RFA
Full Information
NCT ID
NCT03772756
First Posted
December 9, 2018
Last Updated
August 27, 2021
Sponsor
First People's Hospital of Hangzhou
1. Study Identification
Unique Protocol Identification Number
NCT03772756
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
August 16, 2021 (Actual)
Study Completion Date
August 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First People's Hospital of Hangzhou
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma Non-resectable
Keywords
pancreatic adenocarcinoma, radiofrequency ablation, Endoscopic ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EUS-RFA group
Arm Type
Experimental
Arm Description
Patients in EUS-RFA group will undergo endoscopic ultrasound guided radiofrequency ablation(EUS-RFA ) and chemoradiotherapy
Arm Title
control group
Arm Type
Active Comparator
Arm Description
the control group will receive chemoradiotherapy only
Intervention Type
Procedure
Intervention Name(s)
Endoscopic ultrasound guided radiofrequency ablation
Other Intervention Name(s)
EUS-RFA
Intervention Description
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
Radiation
Intervention Name(s)
chemoradiotherapy
Intervention Description
Receive chemoradiotherapy
Primary Outcome Measure Information:
Title
Change in tumour size as measured on EUS and or CT
Description
The tumor size was compared before and after 60 days EUS-RFA
Time Frame
60 days
Title
Change in serum levels of Ca 19-9
Description
Serum levels of Ca 19-9 was compared before and after 60 days EUS-RFA
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Overall survival at 6 months
Description
Survival rate 6 months after EUS-RFA
Time Frame
6 months
Title
Overall survival at 12 months
Description
Survival rate 12 months after EUS-RFA
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zhang
Organizational Affiliation
First People's Hospital of Hangzhou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jianfeng Yang
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
31006
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
23049547
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.
Results Reference
background
Learn more about this trial
EUS-RFA for Unresectable Pancreatic Ductal Adenocarcinoma
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