Irreversible electroporation treatment in patients with pancreatic locally advanced adenocarcinoma

Phase 2

Completed

Conditions: 10017998
Pancreatic adenocarcinoma
Pancreatic Cancer
10017990
10017991

Registration Number: NL-OMON40224

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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

- 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%

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: Clavien-Dindo score 3 or higher complications, these are<br /><br>defined as complications leading to re-intervention (endoscopic, surgical or<br /><br>radiological), admission to the intensive care unit, or mortality. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints: success rate of completing the procedure, duration of the<br /><br>procedure, intraprocedural complications, time to functional recovery, length<br /><br>of hospital stay, complications, readmissions, ablation effect as recorded on<br /><br>cross-sectional imaging, and survival (2 year survival, median survival,<br /><br>progression free survival). </p><br>