Back to resultsQuality of Life After Radiofrequency Ablation of Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Radiofrequency ablation
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- histologically proved locally advanced or metastatic pancreatic cancer. Patients with histologically proved resectable pancreatic cancer with low Karnofsky index.
informed consent
Exclusion Criteria:
- cystic tumor
age under 18
Sites / Locations
- Department of surgery Masaryk University Hostpital Brno
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RFA group
Arm Description
Twenty-fourth consecutive patients with histologically proved pancreatic cancer [stage IIb (n=4), III (n=15), IV (n=5) ]underwent intraoperative RFA of primary tumor.
Outcomes
Primary Outcome Measures
Quality of life after RFA of pancreatic cancer
Quality of life will be evaluated using EORTC C 30 and pan 26 questionaire preoperatively and three months after RFA
Secondary Outcome Measures
3- months perioperative morbidity and mortality
Three months morbidity and mortality will be evaluated using Dindo-Clavien classification
Full Information
NCT ID
NCT02637596
First Posted
December 18, 2015
Last Updated
December 24, 2015
Sponsor
Brno University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02637596
Brief Title
Quality of Life After Radiofrequency Ablation of Pancreatic Cancer
Official Title
Quality of Life After Intraoperative Radiofrequency Ablation of Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brno University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A prospective clinical study evaluating quality of life (QoL) in pancreatic cancer patients treated with intraoperative radiofrequency ablation (RFA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RFA group
Arm Type
Experimental
Arm Description
Twenty-fourth consecutive patients with histologically proved pancreatic cancer [stage IIb (n=4), III (n=15), IV (n=5) ]underwent intraoperative RFA of primary tumor.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation
Other Intervention Name(s)
RFA
Intervention Description
After laparotomy, intraoperative IOUS quided RFA of primary tumor was performed.
Primary Outcome Measure Information:
Title
Quality of life after RFA of pancreatic cancer
Description
Quality of life will be evaluated using EORTC C 30 and pan 26 questionaire preoperatively and three months after RFA
Time Frame
3 years
Secondary Outcome Measure Information:
Title
3- months perioperative morbidity and mortality
Description
Three months morbidity and mortality will be evaluated using Dindo-Clavien classification
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
Overall Survival
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histologically proved locally advanced or metastatic pancreatic cancer. Patients with histologically proved resectable pancreatic cancer with low Karnofsky index.
informed consent
Exclusion Criteria:
cystic tumor
age under 18
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Hlavsa, MD, PhD
Organizational Affiliation
Department of surgery Masaryk University Hospital Brno
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of surgery Masaryk University Hostpital Brno
City
Brno
State/Province
Bohunice
ZIP/Postal Code
62500
Country
Czech Republic
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Publication as manuscript
Learn more about this trial
Quality of Life After Radiofrequency Ablation of Pancreatic Cancer
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