NCT01628458

Brief Summary

The purpose of the study is to determine the safety of radiofrequency ablation of locally advanced pancreatic cancer that can not be surgically removed with the current standard procedures. Complications after the operation will be registered. Moreover a pain score will be determined, length of hospital stay, chemotherapy, survival, progression free survival and a tumour marker.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2012

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

First Submitted

Initial submission to the registry

June 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 26, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

1.8 years

First QC Date

June 20, 2012

Last Update Submit

January 29, 2015

Conditions

Locally Advanced Pancreatic Cancer

Keywords

Pancreatic cancerlocally advancedirresectableRadiofrequencyRFA

Outcome Measures

Primary Outcomes (1)

  • Safety

    The safety will be specified as the percentage of patients with complications directly related to RFA and the routinely performed double-bypass procedure, requiring re-intervention (i.e. endoscopy, radiology, or surgery). This is also known as a complication of grade III or higher in the Clavien-Dindo classification (internationally accepted classification for surgical complications). Moreover all in-hospital complications or complications developed within 30 days after the RFA procedure will be evaluated according to the Clavien-Dindo classification.

    Within 30 days after the RFA procedure

Secondary Outcomes (6)

  • survival

    2 years after RFA procedure

  • VAS pain score

    3 months

  • length hospital stay

    3 months

  • progression free survival

    2 years after RFA procedure

  • CA19-9 response

    2 years after RFA procedure

  • +1 more secondary outcomes

Study Arms (1)

radiofrequency ablation

EXPERIMENTAL
Procedure: radiofrequency ablation (RFA)

Interventions

radiofrequency ablation (RFA)PROCEDURE

RFA with CELON bipolar probes. Settings: Power 30 watts, total energy 15 KJ.

Also known as: CELON Power System, CE mark 0197
radiofrequency ablation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with irresectable locally advanced pancreatic cancer found at laparotomy with histologic diagnosis before start of RFA
  • Patient considered eligible to undergo pancreatic surgery as assessed by the general criteria of the departments of anaesthesiology and surgery of the UMC Utrecht
  • Fully informed written consent given

You may not qualify if:

  • Patients younger than 18 years
  • Pregnancy
  • Patients with distant metastases
  • Portal vein thrombosis seen on CT preoperatively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

Related Publications (2)

  • Cantore M, Girelli R, Mambrini A, Frigerio I, Boz G, Salvia R, Giardino A, Orlandi M, Auriemma A, Bassi C. Combined modality treatment for patients with locally advanced pancreatic adenocarcinoma. Br J Surg. 2012 Aug;99(8):1083-8. doi: 10.1002/bjs.8789. Epub 2012 May 30.

    PMID: 22648697BACKGROUND

  • Girelli R, Frigerio I, Salvia R, Barbi E, Tinazzi Martini P, Bassi C. Feasibility and safety of radiofrequency ablation for locally advanced pancreatic cancer. Br J Surg. 2010 Feb;97(2):220-5. doi: 10.1002/bjs.6800.

    PMID: 20069610BACKGROUND

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

  • Richard van Hillegersberg, Professor

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in surgery

Study Record Dates

First Submitted

June 20, 2012

First Posted

June 26, 2012

Study Start

September 1, 2012

Primary Completion

July 1, 2014

Study Completion

November 1, 2014

Last Updated

February 2, 2015

Record last verified: 2015-01

Locations

NL(1)