pancreatic cancer, pancreatic adenocarcinoma, local ablative therapy, irreversible electroporation alvleesklierkanker, pancreascarcinoom, lokale ablatietherapie, irreversibele electroporatie
Conditions
Interventions
Patients who are deemed eligible for the procedure undergo the same work-up, treatment and follow-up as is currently the case for patients with potential resectable pancreatic cancer and patients unde
Sponsors
AMC Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: • Age 18 years or older • Capable of providing written and oral informed consent • Physically fit to undergo explorative laparotomy • Pancreatic cancer confirmed with pathology (either pre- or intraoperative, pathological diagnosis must be either pancreatic adenocarcinoma or non-intestinal cholangiocarcinoma located in the pancreas) and non-resectability because of locally advanced growth (stage III) confirmed during surgical exploration • One of the following: o Potentially resectable pancreatic cancer based on imaging and planned for surgical exploration with intend for resection, this includes 2 groups of patients  Patients with resectable disease at primary evaluation but are considered non-resectable during surgical exploration  Patients with initially non-resectable disease because of locally advanced pancreatic cancer without metastases, who have stable or regressive (non-metastasized) disease after 3 months of chemotherapy o Locally advanced pancreatic cancer based on imaging without options for non-operative drainage of stomach and bile ducts and therefore planned for surgical exploration with intend for bypass surgery
Exclusion criteria
Exclusion criteria: • Resectable pancreatic cancer during explorative laparotomy • Presence of metastatic disease (peritoneal, liver or other) • Pathological diagnosis of intestinal-type cholangiocarcinoma • History of cardiac arrhythmia’s o Sinus tachycardia (BPM>100) o Sick sinus syndrome o Sinoatrial exit block o AV block o Sinus node reentry o Presence of a pacemaker or defibrillator • Recent history of myocardial infarction • History of epilepsy • Partial portal vein thrombosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the effect of IRE on severe morbidity and mortality occurring until 90 days after IRE treatment. Severe morbidity is defined as defined as Clavien-Dindo score 3 or more. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are the success rate of completing IRE procedure, duration of IRE procedure, intraprocedural complications, the impact of IRE on functional recovery, hospital stay, adverse events, need for re-interventions and readmissions and, effects on survival rates (2-year survival, median survival, progression free survival). Other study parameters are baseline characteristics | — |
Contacts
Public ContactMarc G.H. Besselink
PO Box 22660 ADDRESS G04.196
Outcome results
None listed