University Medical Center Utrecht
Utrecht, 3584 CX, Netherlands
NCT Number: NCT01628458
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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Notify Me18 year–80 year
All sexes
Interventional
Phase 2
Utrecht, 3584 CX, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
RFA with CELON bipolar probes. Settings: Power 30 watts, total energy 15 KJ.
Other names: CELON Power System, CE mark 0197
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.
Time frame: 2 years after RFA procedure
Time frame: 3 months
Time frame: 3 months
Time frame: 2 years after RFA procedure
Time frame: 2 years after RFA procedure
Time frame: 2 years
Type, frequency, dosage and duration of chemotherapy will be registered.
UMC Utrecht
Other
Phase II Study: Radiofrequency Ablation of Locally Advanced Pancreatic Cancer
Acronym: RFA of LAPC
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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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