Quality of Life After Radiofrequency Ablation of Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Quality of Life After Intraoperative Radiofrequency Ablation of Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02637596
• Other study ID #: NT 14579-3
• Status: Completed
• Phase: N/A
• First received: December 18, 2015
• Last updated: December 24, 2015
• Start date: February 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Brno University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Radiofrequency ablation
After laparotomy, intraoperative IOUS quided RFA of primary tumor was performed.

Locations

Country	Name	City	State
Czech Republic	Department of surgery Masaryk University Hostpital Brno	Brno	Bohunice

Sponsors (1)

Lead Sponsor	Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Survival		3 years	Yes
Primary	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	3 years	No
Secondary	3- months perioperative morbidity and mortality	Three months morbidity and mortality will be evaluated using Dindo-Clavien classification	3 years	Yes