Phase II Study: Radiofrequency Ablation of Locally Advanced Pancreatic Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- UMC Utrecht
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Safety
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Patients with distant metastases
- •Portal vein thrombosis seen on CT preoperatively
Arms & Interventions
radiofrequency ablation
Intervention: radiofrequency ablation (RFA) (Procedure)
Outcomes
Primary Outcomes
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
- CA19-9 response(2 years after RFA procedure)
- Chemotherapy(2 years)
- length hospital stay(3 months)
- progression free survival(2 years after RFA procedure)
- survival(2 years after RFA procedure)
- VAS pain score(3 months)
Investigators
R. van Hillegersberg
Professor in surgery
UMC Utrecht