NCT02637596

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable pancreatic-cancer

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
Last Updated

December 28, 2015

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

December 18, 2015

Last Update Submit

December 24, 2015

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 3- months perioperative morbidity and mortality

    3 years

Other Outcomes (1)

  • Overall Survival

    3 years

Study Arms (1)

RFA group

EXPERIMENTAL

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

Interventions

Radiofrequency ablationPROCEDURE

After laparotomy, intraoperative IOUS quided RFA of primary tumor was performed.

Also known as: RFA
RFA group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically proved locally advanced or metastatic pancreatic cancer. Patients with histologically proved resectable pancreatic cancer with low Karnofsky index.
  • informed consent

You may not qualify if:

  • cystic tumor
  • age under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of surgery Masaryk University Hostpital Brno

Brno, Bohunice, 62500, Czechia

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Jan Hlavsa, MD, PhD

    Department of surgery Masaryk University Hospital Brno

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jan Hlavsa MD, PhD, principal investigator

Study Record Dates

First Submitted

December 18, 2015

First Posted

December 22, 2015

Study Start

February 1, 2013

Primary Completion

January 1, 2014

Study Completion

December 1, 2015

Last Updated

December 28, 2015

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will share

Publication as manuscript

Locations

CZ(1)