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Trial record 46 of 2871 for:    Pancreatic Cancer

Quality of Life After Radiofrequency Ablation of Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02637596
Recruitment Status : Completed
First Posted : December 22, 2015
Last Update Posted : December 28, 2015
Sponsor:
Information provided by (Responsible Party):
Jan Hlavsa, Brno University Hospital

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

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Procedure: Radiofrequency ablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Quality of Life After Intraoperative Radiofrequency Ablation of Pancreatic Cancer
Study Start Date : February 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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 Name: RFA




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 3- months perioperative morbidity and mortality [ Time Frame: 3 years ]
    Three months morbidity and mortality will be evaluated using Dindo-Clavien classification


Other Outcome Measures:
  1. Overall Survival [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637596


Locations
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Czech Republic
Department of surgery Masaryk University Hostpital Brno
Brno, Bohunice, Czech Republic, 62500
Sponsors and Collaborators
Brno University Hospital
Investigators
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Principal Investigator: Jan Hlavsa, MD, PhD Department of surgery Masaryk University Hospital Brno

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Responsible Party: Jan Hlavsa, Jan Hlavsa MD, PhD, principal investigator, Brno University Hospital
ClinicalTrials.gov Identifier: NCT02637596     History of Changes
Other Study ID Numbers: NT 14579-3
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: December 28, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication as manuscript
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases