Know Cancer

forgot password

Phase II Study: Radiofrequency Ablation of Locally Advanced Pancreatic Cancer

Phase 2
18 Years
80 Years
Open (Enrolling)
Locally Advanced Pancreatic Cancer

Thank you

Trial Information

Phase II Study: Radiofrequency Ablation of Locally Advanced Pancreatic Cancer

Pancreatic cancer is the fourth leading cause of cancer related death in the Western world.
At time of diagnosis, 20% of patients present with a resectable tumour, 40% with an
irresectable locally advanced tumour (without metastases) and 40% with metastatic disease.
The median survival of patients with irresectable locally advanced pancreatic cancer is only
6 months. Currently, there is no effective treatment for these patients. Therefore, there is
an urgent need for new therapies. Radiofrequency ablation (RFA) is a technique that has been
demonstrated to be effective in the treatment of several irresectable tumours. RFA produces
local tumour destruction through high frequency alternating current flowing from an
electrode implanted directly into the tumour and causing frictional heating. The purpose of
this study is to determine the safety of RFA-pancreas in patients with non-metastasized,
irresectable, locally advanced pancreatic cancer.

Inclusion Criteria:

1. Patients with irresectable locally advanced pancreatic cancer found at laparotomy
with histologic diagnosis before start of RFA

2. Patient considered eligible to undergo pancreatic surgery as assessed by the general
criteria of the departments of anaesthesiology and surgery of the UMC Utrecht

3. Fully informed written consent given

Exclusion Criteria:

1. Patients younger than 18 years

2. Pregnancy

3. Patients with distant metastases

4. Portal vein thrombosis seen on CT preoperatively

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Description:

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.

Outcome Time Frame:

Within 30 days after the RFA procedure

Safety Issue:


Principal Investigator

Richard van Hillegersberg, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMC Utrecht


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

September 2012

Completion Date:

June 2013

Related Keywords:

  • Locally Advanced Pancreatic Cancer
  • Pancreatic cancer
  • locally advanced
  • irresectable
  • Radiofrequency
  • RFA
  • Pancreatic Neoplasms