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OpenTrials
Completed

NCT Number: NCT01628458

Safety Study of Radiofrequency Ablation of Locally Advanced Pancreatic Cancer

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Radiofrequency ablation (RFA)

Procedure

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

Other names: CELON Power System, CE mark 0197

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study title

Phase II Study: Radiofrequency Ablation of Locally Advanced Pancreatic Cancer

Acronym: RFA of LAPC

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 26, 2012
Registry last updated
Feb 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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