Impact of Margin-accentuation IRE in Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— IRE Marg  

Official title:

Impact of Margin-accentuation IRE in Pancreatic Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02952859
• Other study ID #: IRE Marg
• Status: Terminated
• Start date: January 2017
• Est. completion date: February 25, 2020

Study information

• Verified date: February 2020
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pancreatic cancer is the fourth leading cause of cancer deaths overall and second after colon and rectum cancer among gastrointestinal cancers in Western countries. In Switzerland, 1,172 new pancreatic cancer patients were diagnosed in 2012. Unfortunately, only about 20% of pancreatic cancer patients present at a disease state that allows surgical resection while 30% have locally advanced, unresectable disease and 50% show distant metastases. While the latter two are currently treated in a palliative setting with median survival of at most 6-12 months, patients who undergo tumor resection with curative intentions also achieve only 5-year survival rates of 20-25% in best hands. The reasons for this poor outcome are thought to be chemoresistance, early establishment of metastatic disease, and importantly, high rates of R1 resections. Up to 80% of pancreatic resections have positive resection margins which are often found within the vascular groove and/or at the retroperitoneal margin, close to the superior mesenteric artery. This high rate of positive margins is only found after meticulous pathological work-up and is normally not detected after standard assessment of the specimen. However, the clinical importance of the high positivity of resection margin is even more highlighted as patients undergoing portal vein resection despite negativity of portal vein invasion after regular pathological work-up show significantly better survival compared to patients without portal vein resection. In sum, given the overall poor prognosis despite tumor resection, auxiliary treatment strategies to improve long-term outcomes are desperately needed. Over the last 5 years, irreversible electroporation (IRE) emerged as a non-thermal ablative modality that allows local tumor destruction with sparing vital structures like arteries, venous vessels, as well as the bile and pancreatic duct. There is increasing evidence that IRE for locally unresectable pancreatic cancer is effective with an increase in local progression free survival , distant progression free survival and overall survival compared to historic controls.Data on margin accentuation IRE are sparse while in a recent study published by Martin et al showed that margin accentuation among patients with borderline resectable disease can be performed safe and efficacious if the treatment can be performed "with a high degree of technical ability and skill set".

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: February 25, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with histology proven or highly suspected potentially resectable or borderline resectable pancreatic cancer will be included.

• Age = 18 years

• Able to undergo general anesthesia (ASA = 3)

• Performance status ECOG <=2 (Eastern Cooperative Oncology Group)

• Life expectancy of at least 6 months

• Resectable or borderline resectable proven pancreatic adenocarcinoma of the pancreas

Exclusion Criteria:

• Cardiac conduction abnormalities (AV conduction abnormalities)

• History of epilepsy

• Recent history of myocardial infarction (2 months)

• Evidence of distant metastasis (e.g. liver, lung, peritoneum)

• Informed consent cannot be given by the patient

• Known hypersensitivity to the IRE electrodes (stainless steel 304L)

• Women of childbearing potential who are pregnant, breast feeding, or not taking an adequate method of contraception at the time of procedure

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• Irreversible electroporation

Locations

Country	Name	City	State
Switzerland	Inselhospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from diagnosis to death for any reason	Postoperative complications	6 weeks
Primary	Time from diagnosis to death for any reason	Local and distal recurrence, cancer specific survival	3 months
Primary	Time from diagnosis to death for any reason	Local and distal recurrence, cancer specific survival	6 months
Primary	Time from diagnosis to death for any reason	Local and distal recurrence, cancer specific survival	9 months