Safety Study of Radiofrequency Ablation of Locally Advanced Pancreatic Cancer (RFA of LAPC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01628458
Recruitment Status : Completed
First Posted : June 26, 2012
Last Update Posted : February 2, 2015
Information provided by (Responsible Party):
R. van Hillegersberg, UMC Utrecht

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.

Condition or disease Intervention/treatment Phase
Locally Advanced Pancreatic Cancer Procedure: radiofrequency ablation (RFA) Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study: Radiofrequency Ablation of Locally Advanced Pancreatic Cancer
Study Start Date : September 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: radiofrequency ablation Procedure: radiofrequency ablation (RFA)
RFA with CELON bipolar probes. Settings: Power 30 watts, total energy 15 KJ.
Other Name: CELON Power System, CE mark 0197

Primary Outcome Measures :
  1. Safety [ Time Frame: Within 30 days after the RFA procedure ]
    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.

Secondary Outcome Measures :
  1. survival [ Time Frame: 2 years after RFA procedure ]
  2. VAS pain score [ Time Frame: 3 months ]
  3. length hospital stay [ Time Frame: 3 months ]
  4. progression free survival [ Time Frame: 2 years after RFA procedure ]
  5. CA19-9 response [ Time Frame: 2 years after RFA procedure ]
  6. Chemotherapy [ Time Frame: 2 years ]
    Type, frequency, dosage and duration of chemotherapy will be registered.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01628458

University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Principal Investigator: Richard van Hillegersberg, Professor UMC Utrecht

Responsible Party: R. van Hillegersberg, Professor in surgery, UMC Utrecht Identifier: NCT01628458     History of Changes
Other Study ID Numbers: 12-018
First Posted: June 26, 2012    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: January 2015

Keywords provided by R. van Hillegersberg, UMC Utrecht:
Pancreatic cancer
locally advanced

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases