Quality of Life After Radiofrequency Ablation of Pancreatic Cancer

December 24, 2015 updated by: Jan Hlavsa, Brno University Hospital

Quality of Life After Intraoperative Radiofrequency Ablation of Pancreatic Cancer

A prospective clinical study evaluating quality of life (QoL) in pancreatic cancer patients treated with intraoperative radiofrequency ablation (RFA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

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

  • Czech Republic
    • Bohunice
      • Brno, Bohunice, Czech Republic, 62500
        • Department of surgery Masaryk University Hostpital Brno

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RFA group
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.
Procedure: Radiofrequency ablation
After laparotomy, intraoperative IOUS quided RFA of primary tumor was performed.
Other Names:
  • RFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life after RFA of pancreatic cancer
Time Frame: 3 years
Quality of life will be evaluated using EORTC C 30 and pan 26 questionaire preoperatively and three months after RFA
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3- months perioperative morbidity and mortality
Time Frame: 3 years
Three months morbidity and mortality will be evaluated using Dindo-Clavien classification
3 years

Other Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

Brno University Hospital

Investigators

  • Principal Investigator: Jan Hlavsa, MD, PhD, Department of surgery Masaryk University Hospital Brno

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

February 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 18, 2015

First Submitted That Met QC Criteria

December 18, 2015

First Posted (Estimate)

December 22, 2015

Study Record Updates

Last Update Posted (Estimate)

December 28, 2015

Last Update Submitted That Met QC Criteria

December 24, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NT 14579-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Publication as manuscript

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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