Pancreatic adenocarcinoma Pancreatic Cancer
Conditions
Interventions
IRE during open surgery (during the same procedure as intended for resection or
confirmation of unresectability).
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
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) during surgical exploration - One of the following: * Potentially resectable panreatic 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 * Locally advanced pancreatic cancer based on imaging without options for non-operative drainage of stomach and bileducts 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 * Sinus tachycardia (BPM>100) * Sick sinus syndrome * Sinoatrial exit block * AV block * Sinus node reentry * Presence of a pacemaker or defibrillator - Recent history of myocardial infarction - History of epilepsy - Partial portal vein thrombosis - Both narrowing (sclerosis) of the portal vein and a reduced diameter of either the common hepatic artery, celiac trunc or superior mesenteric artery of >50%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Clavien-Dindo score 3 or higher complications, these are defined as complications leading to re-intervention (endoscopic, surgical or radiological), admission to the intensive care unit, or mortality. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: success rate of completing the procedure, duration of the procedure, intraprocedural complications, time to functional recovery, length of hospital stay, complications, readmissions, ablation effect as recorded on cross-sectional imaging, and survival (2 year survival, median survival, progression free survival). | — |
Countries
Netherlands
Outcome results
None listed