Quality of Life After Radiofrequency Ablation of Pancreat... | NCT02637596

Studies
Quality of Life After Radiofrequency Ablation of Pancreatic Cancer

NCT02637596

Sponsor

Brno University Hospital

Status

Completed

Last Update Posted

Dec 28, 2015Estimated

Enrollment

1Actual

Phase

Not Applicable

Conditions

Pancreatic Cancer

Interventions

Radiofrequency ablation

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Jan 2014Actual

Completion Date

Dec 2015Actual

First Submitted Date

Dec 18, 2015

First Submission Date that Met QC Criteria

Dec 18, 2015

First Posted Date

Dec 22, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2015

Last Update Posted Date

Dec 28, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jan Hlavsa, Jan Hlavsa MD, PhD, principal investigator, Brno University HospitalPrincipal Investigator

Lead Sponsor

Brno University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Radiofrequency ablation	Procedure	After laparotomy, intraoperative IOUS quided RFA of primary tumor was performed.	RFA group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Measure	Description	Time Frame
Overall Survival		3 years

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jan Hlavsa, MD, PhD	Department of surgery Masaryk University Hospital Brno	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of surgery Masaryk University Hostpital Brno		Brno	Bohunice	62500	Czechia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Publication as manuscript

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000078703	Radiofrequency Ablation

Ancestor Terms

ID	Term
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided