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

UMC Utrecht

Status and phase: Completed; Phase 2

Conditions: Locally Advanced Pancreatic Cancer

Treatments: Procedure: radiofrequency ablation (RFA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01628458

12-018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

radiofrequency ablation

Experimental group

Treatment:

Procedure: radiofrequency ablation (RFA)