Back to resultsEUS-RFA for Unresectable Pancreatic Cancer
Primary Purpose
Pancreatic Ductal Adenocarcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EUS-RFA
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Ductal Adenocarcinoma focused on measuring Pancreatic ductal adenocarcinoma, Unresectable pancreatic cancer, Radiofrequency ablation, Endoscopic ultrasound
Eligibility Criteria
Inclusion Criteria:
- age 20 to 80 years old. ② unresectable PDAC based on review of abdominal cross-sectional imaging (CT or MRI) and cytology/ histology results. ③Intolerance to chemotherapy due to side effects or patient's comorbidities.
Exclusion Criteria:
- Pregnancy or breast-feeding；②ECOG performance status 3 or 4；③Patients with distant metastases or malignant ascites, life expectancy less than 3 months.
Sites / Locations
- Hangzhou First People's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EUS-RFA
Arm Description
Patients were placed in the lateral position under deep sedation with supplementary oxygen and electrocardiograph monitoring. The target tumor was identified by EUS, then the biopsy needle stylet was removed and replace with the RFA probe. RF energy was applied for 90-120 seconds at 5 Watts. Wait 1 minute before repositioning the Habib™ EUS RFA needle and repeat procedure as many times as needed to ensure complete ablation of the tumor. EUS-guided celiac plexus neurolysis (EUS-CPN) was performed on patients with intractable upper abdominal pain.
Outcomes
Primary Outcome Measures
Tumor size
Tumor size
Secondary Outcome Measures
Serum levels of CA19-9
Serum levels of CA19-9 before and after surgery
survival rate
including Overall survival
Adverse events
Adverse events
Full Information
NCT ID
NCT04310111
First Posted
March 10, 2020
Last Updated
August 27, 2021
Sponsor
First People's Hospital of Hangzhou
1. Study Identification
Unique Protocol Identification Number
NCT04310111
Brief Title
EUS-RFA for Unresectable Pancreatic Cancer
Official Title
Efficacy and Safety of Endoscopic Ultrasonography-guided Radiofrequency Ablation in Treatment of Locally Advanced, Unresectable Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
July 25, 2021 (Actual)
Study Completion Date
August 25, 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 clinical application of intraoperative or percutaneous radiofrequency ablation (RFA) for pancreatic ductal adenocarcinoma (PDAC) is limited due to higher mortality and incidence of adverse events. The aim of this study was to evaluate the efficacy and safety of endoscopic ultrasonography-guided RFA (EUS-RFA) for locally advanced, unresectable PDAC. Patients with unresectable PDAC who underwent EUS-RFA were included from September 2013 to June 2016. Pre- and post-procedural clinical data was retrospective collected.
Detailed Description
evaluate the efficacy and safety of endoscopic ultrasonography-guided RFA (EUS-RFA) for locally advanced, unresectable PDAC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Ductal Adenocarcinoma
Keywords
Pancreatic ductal adenocarcinoma, Unresectable pancreatic cancer, Radiofrequency ablation, Endoscopic ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EUS-RFA
Arm Type
Experimental
Arm Description
Patients were placed in the lateral position under deep sedation with supplementary oxygen and electrocardiograph monitoring. The target tumor was identified by EUS, then the biopsy needle stylet was removed and replace with the RFA probe. RF energy was applied for 90-120 seconds at 5 Watts. Wait 1 minute before repositioning the Habib™ EUS RFA needle and repeat procedure as many times as needed to ensure complete ablation of the tumor. EUS-guided celiac plexus neurolysis (EUS-CPN) was performed on patients with intractable upper abdominal pain.
Intervention Type
Procedure
Intervention Name(s)
EUS-RFA
Intervention Description
Use EUS-RFA to treat unresectable pancreatic cancer
Primary Outcome Measure Information:
Title
Tumor size
Description
Tumor size
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Serum levels of CA19-9
Description
Serum levels of CA19-9 before and after surgery
Time Frame
2 years
Title
survival rate
Description
including Overall survival
Time Frame
2 years
Title
Adverse events
Description
Adverse events
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 20 to 80 years old. ② unresectable PDAC based on review of abdominal cross-sectional imaging (CT or MRI) and cytology/ histology results. ③Intolerance to chemotherapy due to side effects or patient's comorbidities.
Exclusion Criteria:
Pregnancy or breast-feeding；②ECOG performance status 3 or 4；③Patients with distant metastases or malignant ascites, life expectancy less than 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zhang, M.S
Organizational Affiliation
First People's Hospital of Hangzhou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
31006
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
EUS-RFA for Unresectable Pancreatic Cancer
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