PANFIRE Study: Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma

NCT01939665 | Completed Phase 1 DMC

• 2 other identifiers: NL42888.029.132013/155
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are applied to tumorous tissue. These pulses alter the existing transmembrane potential of the cell membranes, and create 'nanopores', after which the cell dies through loss of homeostasis. The purpose of this study is to investigate the safety of percutaneous IRE in the treatment of patients with locally advanced pancreatic carcinoma (LAPC). Other objectives are feasibility and efficacy of IRE based upon symptomatic response and tumor response. Fourty patients with histologically confirmed locally advanced pancreatic adenocarcinoma (\<5cm) will undergo percutaneous irreversible electroporation of the tumor using CT and ultrasound guidance. After IRE, patients will be carefully monitored and any (serious) adverse events are registered. Follow-up will consist of frequent CT scanning, as well as serum CA19.9 tumor marker. We hypothesize that IRE in the pancreas will induce good symptom palliation and local tumor control, without causing severe complications.

Conditions

Locally Advanced Pancreatic Carcinoma (LAPC); Non-metastasized Unresectable Pancreatic Carcinoma; Pancreatic Cancer

Keywords

Locally advanced pancreatic carcinoma; LAPC; Irreversible electroporation; NanoKnife; IRE; Safety; Efficacy; Non-thermal ablation; Percutaneous ablation; Low Energy Direct Current

Outcome Measures

Primary Outcomes (1)

• Safety (number of adverse events)

  Number of adverse events of IRE-treatment (within 12 months after treatment) are registered and analyzed according to the CTCAE version 4.0. Complications related to IRE are early complications during hospital admission (e.g. bile leak, bowel leak, infection, pancreatitis), or late complications of IRE such as bile duct stenosis that become apparent during follow-up in the year after treatment.

  early: 90 days; late: 12 months

Secondary Outcomes (1)

• Tumor response

  12 months

Study Arms (1)

Irreversible electroporation

EXPERIMENTAL

Single arm study: Percutaneous irreversible electroporation of locally advanced pancreatic carcinoma

Device: NanoKnife "Irreversible electroporation (IRE)"

Interventions

NanoKnife "Irreversible electroporation (IRE)" DEVICE

Tumor ablation with irreversible electroporation with the NanoKnife

Also known as: IRE, NanoKnife

Irreversible electroporation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiologic confirmation of LAPC by at least ceCT of chest and abdomen (with the upper abdomen scanned according to a dedicated 3mm slice multiphase pancreatic tumor protocol), performed maximum 2 weeks prior to the procedure;
• Maximum tumor diameter ≤ 5 cm;
• Histological or cytological confirmation of pancreatic adenocarcinoma;
• Age ≥ 18 years;
• ASA-classification 0 - 3
• Life expectancy of at least 12 weeks;
• Hemoglobin ≥ 5.6 mmol/L;
• Absolute neutrophil count (ANC) ≥ 1,500/mm3;
• Platelet count ≥ 100\*109/l;
• Total bilirubin ≤ 1.5 times the upper limit of normal (ULN);
• ALT and AST ≤ 2.5 x ULN;
• Serum creatinine ≤ 1.5 x ULN or a calculated creatinine clearance ≥ 50 ml/min;
• Prothrombin time or INR \< 1.5 x ULN;
• Activated partial thromboplastin time \< 1.25 x ULN (therapeutic anticoagulation therapy is allowed if this treatment can be interrupted as judged by the treating physician);
• Written informed consent;

You may not qualify if:

• Resectable pancreatic adenocarcinoma as discussed by our multidisciplinary hepatobiliary team;
• Extrapancreatic metastases;
• Successful down staging after (radio)chemotherapy from previous unresectable/borderline tumor to resectable tumor;
• Stage IV pancreatic carcinoma;
• History of epilepsy;
• History of cardiac disease:
• Congestive heart failure \>NYHA class 2;
• Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening);
• Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers for antihypertensive regimen are permitted);
• Uncontrolled hypertension. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen;
• Compromised liver function (e.g. signs of portal hypertension, INR \> 1,5 without use of anticoagulants, ascites);
• Uncontrolled infections (\> grade 2 NCI-CTC version 3.0);
• Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment;
• Immunotherapy ≤ 6 weeks prior to the procedure;
• Chemotherapy ≤ 6 weeks prior to the procedure;

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

VU University Medical Center

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Related Publications (2)

• Ruarus AH, Vroomen LGPH, Geboers B, van Veldhuisen E, Puijk RS, Nieuwenhuizen S, Besselink MG, Zonderhuis BM, Kazemier G, de Gruijl TD, van Lienden KP, de Vries JJJ, Scheffer HJ, Meijerink MR. Percutaneous Irreversible Electroporation in Locally Advanced and Recurrent Pancreatic Cancer (PANFIRE-2): A Multicenter, Prospective, Single-Arm, Phase II Study. Radiology. 2020 Jan;294(1):212-220. doi: 10.1148/radiol.2019191109. Epub 2019 Nov 5.

  PMID: 31687922 DERIVED

• Witvliet-van Nierop JE, Lochtenberg-Potjes CM, Wierdsma NJ, Scheffer HJ, Kazemier G, Ottens-Oussoren K, Meijerink MR, de van der Schueren MAE. Assessment of Nutritional Status, Digestion and Absorption, and Quality of Life in Patients with Locally Advanced Pancreatic Cancer. Gastroenterol Res Pract. 2017;2017:6193765. doi: 10.1155/2017/6193765. Epub 2017 Aug 20.

  PMID: 28912804 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Martijn R Meijerink, MD, PhD

  VU University Medical Center, Department of Radiology and Nuclear Medicine

  PRINCIPAL INVESTIGATOR

• Geert Kazemier, Prof. Dr.

  VU University Medical Center, Department of Surgery

  PRINCIPAL INVESTIGATOR

• Cornelis van Kuijk, Prof. Dr.

  VU University Medical Center, Head of Department of Radiology,

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 11, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 20, 2022

Record last verified: 2022-12

Locations

NL (1)