Clinical trial · Interventional
A Clinical Research About Using Irreversible Electroporation to Treat Locally Advanced Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Pancreatic cancers is one the most important malignancies with highest mortality in the world. The prognosis of these patients is very poor. Although some patients with early-diagnosed disease could receive surgical intervention, a majority (70%to 80%) of patients present with locally advanced or metastatic status are inoperable. Patients in this late status usually are recommended to receive palliative bypass operation such as choledochojejunostomy and/or gastrojejunostomy and palliative radiotherapy for the pancreatic cancer. Radiofrequency ablation (RFA) used to be expected an alternative therapy. However, the main drawback of RFA is its side effect to damage adjacent structure such as bile duct, and the tumors located adjacent to vessels could not be ablated well.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irreversible Electroporation (IRE) System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- irreversible electroporation (IRE)
- description
- IRE (AngioDynamics, NY) To use 2 to 6 unipolar electrodes in a predetermined grid pattern. 90 pulses of 2,000 - 3,000 V were applied with a pulse generator (AngioDynamics, NY) across the gap between the electrodes for 100 microseconds (0.1 msec) per each ablation.
- interventionNames
- Device: Irreversible Electroporation (IRE) System
Primary outcomes (1)
- measure
- Tumor response
- timeFrame
- 1 month after treatment
- description
- Tumor response will be evaluated by abdominal computed tomography (CT) or magnetic resonance imaging (MRI).
Secondary outcomes (6)
- measure
- Eastern Cooperative Oncology Group (ECOG) evaluation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for this study: 1. Locally advanced pancreatic cancer is defined as per the 7th edition of the American Joint Committee on Cancer (AJCC) staging system for pancreatic cancer -described as arterial encasement of either the celiac axis or superior mesenteric artery or both. 2. Biliary tract or intestine is compromised by tumor, palliative bypass operation (hepaticojejunostomy and/or gastrojejunostomy) is considered to be performed. 3. Eastern Cooperative Oncology Group (ECOG) score of 0-1, 4. American Society of Anaesthesiologists (ASA) score ≤ 3, 5. Adequate bone marrow, liver and renal function. Platelet count ≥ 100 K/Μl. Total bilirubin ≦ 5 mg/dL. alanine transaminase (ALT) and aspartate transaminase (AST) \< 5 x upper limit of normal. prothrombin time (PT)- international normalized ratio (INR) ≦ 2.0 (5). Serum creatinine ≦ 1.5 x upper limit of normal 6. Prior Informed Consent Form 7. Life expectancy of at least 3 months. Exclusion Criteria: Patients presenting with any of the following will not be enrolled into this study: 1. History of cardiac disease: 2. Congestive heart failure \>New York Heart Association (NYHA) class 2 3. Active coronary artery disease (CAD) (myocardial infarction more than 6 months prior to study entry is allowed) 4. Cardiac arrhythmias (\>Grade 2 NCI-CTCAE Version 3.0) which are poorly controlled with anti-arrhythmic therapy or requiring pace maker 5. Uncontrolled hypertension 6. Any active metal implanted device (eg Pacemaker), 7. Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, 8. Received treatment with an investigational agent/ procedure within 30 days prior to treatment with the IRE System, 9. Known history of human immunodeficiency virus (HIV) infection 10. Patients with resectable lesions.
References
Publications (0)
Data not yet available