Main objectiveTo investigate feasibility and safety of tumor ablation using IRE in patients with irresectable locally advanced pancreatic head carcinomas.Secondary objective(s)To investigate tumor downstaging efficacy, pain perception and hospital…
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
Safety and feasibility of the procedure
Secondary outcome
Tumor downstaging
VAS pain score
Hospital stay (days)
Immunological effects
Background summary
In the Netherlands neoadjuvant treatment for T3 or T4 tumors in patients free
of distant metastasis is not a standard therapy. In the near future the
PREOPANC trial will evaluate radiochemotherapy for borderline resectabel
pancreatic head adenocarcinomas. Involvement of venous structures (beside
complete thrombosis with portal hypertension) is not regard as an absolute
contraindication for explorative laparotomy. Involvement of the superior
mesenteric artery, celiac trunc or hepatic arteries is. Therefore a significant
number of patients undergo an laparotomy without performing a pancreatic head
resection. Mostly a biliary and gastrointestinal bypass is provided.
Postoperatively chemotherapy is regarded as an adjunct to palliative treatment.
When patients are postoperatively without clinical symptoms chemotherapy is not
regarded as providing significant benefit.
Study objective
Main objective
To investigate feasibility and safety of tumor ablation using IRE in patients
with irresectable locally advanced pancreatic head carcinomas.
Secondary objective(s)
To investigate tumor downstaging efficacy, pain perception and hospital stay in
patients following IRE of irresectable locally advanced pancreatic head
carcinomas .
Study design
Patients with pancreatic head carcinoma with involvement of venous structures
to an extent that explorative laparotomy is warranted are eligible for IRE
treatment when during laparotomy the tumor is proven to be irresectable. We
anticipate to include 15 patients in 12 months.
Intervention
Irreversible electroporation (IRE) is a new ablation technique [Rubinsky 2007,
Lee 2010]. By changing the electric potential across the cell membrane, the
lipid bilayer is disrupted and becomes porous. With high voltages this process
is irreversible leading by apoptosis to cell death. IRE is already effective at
settings before heat is produced. Therefore it is defined as a non-thermal
ablation technique were heatsink and direct thermal damage is not an issue. IRE
is also shown to spare connective tissue architecture, leaving the
architecture of bile ducts and other vital structures intact. This will allow
ablations of tumors with close relation to vital structures.
Study burden and risks
Because of a possible advatage for survival, the minimal risk of IRE, as well
as de CT-scans, is considerd acceptable. The CT-scans that are to be made, (5
for a 9month survival and a maximum of 9 for a 2 year survival) is not
considered to be a risk, and is considered to be an acceptabel burden. The
follow-up scans are stopped when there is progression of disease. The
questionnaires and the venal punctions are not considered to be a risk, nor a
burden.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
Pre-operative inclusion criteria
• 18 years of age
• Tumor in the pancreas suspected for adenocarcinoma according to diagnostic set in the national guideline*
• Based on preoperative imaging the tumor is judged as resectable in the multidisciplinary meeting, but is also shown to have at least abutment of a venous vascular structure (portal vein, superior mesenteric vein) (see table 1 in Appendix A)
• Tumor size must be < 4 cm at the time of IRE treatment and must be measurable
• Karnofsky Performance Status score of >70% or ECOG of 0 to 1
• INR < 1.3
• ANC > 1.5x109/L
• Hemoglobin >6mmol/L
• Platelets > 100x109/L
• Renal function: eGFR >50ml/min
• Bilirubin level <250mmol/L
• Willing and able to comply with the protocol requirements
• Able to comprehend and have signed an Informed Consent Form (ICF) to participate in the study
* Suspected tumor in the pancreas on US and CT/MR, or, if necessary, followed by endoscopic ultrasound or ERCP with or without cytological and/or histological diagnosis (www.oncoline.nl/pancreascarcinoom).;Per-operative inclusion criteria
• Unresectable during intraoperative ultra sound investigation after minimal surgical exploration:
• Extensive tumor growth around superior mesenteric vein and their side-branches (see table 2 in Appendix A).
• Involvement of arterial structures (see table 2 in Appendix A)
• Per-operative diagnosis confirmed by frozen section analysis
Exclusion criteria
• Contraindications for laparotomy or IRE
• Resectable at laparotomy
• Evidence of distant metastases (pre or per-operative) including cytological proven N2 metastases
• Stenosis >50% of Common Hepatic Artery and/or Celiac Trunc
• Inability to stop anticoagulant therapy for 7 days prior to and 7 days post treatment with the NanoKnife System
• Known history of contrast allergy that cannot be medically managed
• Women who are pregnant or currently breast feeding
• Women of child bearing potential who are not willing to use hormonal contraception or intrauterine device (IUD) during the study
• Have a cardiac pacemaker or defibrillator
• Have metal parts in the vicinity of lesions to be ablated at the time of treatment with the NanoKnife System
• Recent history of myocardial infarction (within the past 3 months)
• Patients with a history of Epilepsy
• Patients with a current history of clinically significant Cardiac Arrhythmia
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL45048.058.13 |