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| Name | Class |
|---|---|
| Institute of Oncology Ljubljana | OTHER |
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The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy (ECT) with bleomycin in pancreatic cancer in clinical study phase I and II. After surgical resection of pancreatic cancer, the posterior resection surface will be treated with ECT with the intention to lower disease recurrence rate.
The study will include 10patients in phase I clinical study and additional 10patients in phase II clinical study (or in the extension of the clinical study), which will fulfill inclusion criteria.
Treatment effectiveness will be evaluated by US or CT imaging, to detect early local recurrence of the disease. Long term effectiveness of the treatment will be evaluated by frequent and precise patient follow-up. During follow-up clinical examination, laboratory tests, tumor markers (Ca 19-9 and CEA) and US/CT imaging will be performed.
The secondary objectives of the trial are to quantify the impact of the treatment on the patient's quality of life, tolerance to the therapy and suitability for larger study to be conducted.
The study will be conducted on patients with resectable pancreatic cancer. 10patients will be included in phase I clinical study and additional 10patients in phase II clinical study (or in the extension of the clinical study).
After surgical resection of pancreatic cancer, the posterior resection surface will be treated with purpose to lower disease recurrence rate. Plate electrodes will be used for ECT treatment, the electrodes will be placed between choledochal cut-end, truncus celiacus, remaining of the pancreas and aortal lymph nodes.
ECT will be performed within 8-28 min after intravenous in bolus administration of bleomycin (15 mg/m2). Triggering of electric pulses will be synchronized with ECG signals, through the ECG triggering device AccuSync to avoid delivery of pulses in vulnerable period of the heart.
All patients will be treated after the procedure has been thoroughly described to them and have signed informed consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Cliniporator Vitae® and chemotherapy drug Bleomycin PHC 15 e. (United States Pharmacopeia - USP) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrochemotherapy - electroporation with Cliniporator Vitae® and chemotherapy drug Bleomycin PHC 15 e. (United States Pharmacopeia - USP) | Procedure | Procedure: Electrochemotherapy Exploration, anesthesia, pancreatic cancer resection, bleomycin administration, electroporation, formation of all anastomoses. Device: Cliniporator Vitae® Positioning of plate electrodes according to landmarks, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization, approximately 1000V/cm), removal of electrodes. The maximum duration of procedure is 90 minutes, after liver mobilization. Drug: Bleomycin PHC 15 e. (United States Pharmacopeia - USP) Intravenous bolus administration of bleomycin (15 mg/m2) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Postprocedural Complications for Evaluation of Feasibility and Safety | Every patient will be closely followed-up after operation with clinical examination and blood tests (hemogram, comprehensive metabolic panel, liver panel) according to the study protocol (day 1, 3, 7 after operation). In case of detected abnormalities additional imaging (US and/or CT) will take place. Findings will be noted and reported in line with Clavien-Dindo classification of surgical complications. The primary measure is to detect complications after surgery and to determine whether the complication is related to electrochemotherapy treatment or not. | 7 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival | Disease-free survival is defined as the amount of time a subject survives without disease recurrence after treatment. Recurrence is defined as significant elevation of tumor markers Ca19-9 and CEA after operation (normal value of Ca19-9 is under 37.0 kU/L, normal value of CEA is under 4.2 µg/L). The appearance of one or more lesions on imaging investigation (US and/or CT) is also considered a recurrence. The tumor markers and imaging investigations will be performed according to study protocol (tumor markers 1, 3, 6, 12 and 24 months after operation; imaging 1, 3, 6, 12, 18 and 24 months after operation - the imaging method will be CT or MR with or without contrast, with the exception of 1 and 18 months after the operation when an US will be performed). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mihajlo Djokic, MD, PhD | University Medical Centre Ljubljana, Ljubljana, Slovenia | Principal Investigator |
| Blaz Trotovsek, MD, PhD | University Medical Centre Ljubljana, Ljubljana, Slovenia | Study Director |
| Gregor Sersa, PhD | Institute of Oncology, Ljubljana, Slovenia | Study Director |
| Zan Cebron, MD | University Medical Centre Ljubljana, Ljubljana, Slovenia | Study Chair |
| Miha Petric, MD | University Medical Centre Ljubljana, Ljubljana, Slovenia | Study Chair |
| David Badovinac, MD | University Medical Centre Ljubljana, Ljubljana, Slovenia | Study Chair |
| Masa Bosnjak, PhD | Institute of Oncology, Ljubljana, Slovenia | Study Chair |
| Bostjan Markelc, PhD | Institute of Oncology, Ljubljana, Slovenia | Study Chair |
| Maja Cemazar, PhD | Institute of Oncology, Ljubljana, Slovenia |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Ljubljana, Ljubljana, Slovenia | Ljubljana | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37748261 | Result | Cebron Z, Djokic M, Petric M, Cemazar M, Bosnjak M, Sersa G, Trotovsek B. Intraoperative electrochemotherapy of the posterior resection surface after pancreaticoduodenectomy: Preliminary results of a hybrid approach treatment of pancreatic cancer. Bioelectrochemistry. 2024 Feb;155:108576. doi: 10.1016/j.bioelechem.2023.108576. Epub 2023 Sep 22. |
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| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Group | Cliniporator Vitae® and chemotherapy drug Bleomycin PHC 15 e. (United States Pharmacopeia - USP) Electrochemotherapy - electroporation with Cliniporator Vitae® and chemotherapy drug Bleomycin PHC 15 e. (United States Pharmacopeia - USP): Procedure: Electrochemotherapy Exploration, anesthesia, pancreatic cancer resection, bleomycin administration, electroporation, formation of all anastomoses. Device: Cliniporator Vitae® Positioning of plate electrodes according to landmarks, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization, approximately 1000V/cm), removal of electrodes. The maximum duration of procedure is 90 minutes, after liver mobilization. Drug: Bleomycin PHC 15 e. (United States Pharmacopeia - USP) Intravenous bolus administration of bleomycin (15 mg/m2) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2026 |
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| 1, 3, 6, 12, 18 and 24 months after operation |
| Overall Survival | Overall survival is defined as the amount of time a subject survives after therapy. Patient enrolled in the study will be followed up for at least five years. During first two years after surgery follow-up will be as written above, after that period patient will be followed-up according every 6 months. | From the time of surgical treatment until 5 years after surgery |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group | According to the study protocol 10 patients were enrolled in the study. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Postprocedural Complications for Evaluation of Feasibility and Safety | Every patient will be closely followed-up after operation with clinical examination and blood tests (hemogram, comprehensive metabolic panel, liver panel) according to the study protocol (day 1, 3, 7 after operation). In case of detected abnormalities additional imaging (US and/or CT) will take place. Findings will be noted and reported in line with Clavien-Dindo classification of surgical complications. The primary measure is to detect complications after surgery and to determine whether the complication is related to electrochemotherapy treatment or not. | All the enrolled patients were included in analysis. | Posted | Count of Participants | Participants | 7 days after operation |
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| Secondary | Disease-free Survival | Disease-free survival is defined as the amount of time a subject survives without disease recurrence after treatment. Recurrence is defined as significant elevation of tumor markers Ca19-9 and CEA after operation (normal value of Ca19-9 is under 37.0 kU/L, normal value of CEA is under 4.2 µg/L). The appearance of one or more lesions on imaging investigation (US and/or CT) is also considered a recurrence. The tumor markers and imaging investigations will be performed according to study protocol (tumor markers 1, 3, 6, 12 and 24 months after operation; imaging 1, 3, 6, 12, 18 and 24 months after operation - the imaging method will be CT or MR with or without contrast, with the exception of 1 and 18 months after the operation when an US will be performed). | Not Posted | 1, 3, 6, 12, 18 and 24 months after operation | Participants | |||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is defined as the amount of time a subject survives after therapy. Patient enrolled in the study will be followed up for at least five years. During first two years after surgery follow-up will be as written above, after that period patient will be followed-up according every 6 months. | Not Posted | From the time of surgical treatment until 5 years after surgery | Participants |
Postoperative complications: 0-30 days after surgery. Long-term adverse events: from 31 days after surgery through 24 months postoperatively.
Adverse events were collected for all participants. Postoperative complications occurring within 30 days after surgery were recorded. Long-term adverse events were collected from 31 days after surgery through 24 months of follow-up. All events are reported in the tables below, including the number of participants affected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Group - Intraoperative Electrochemotherapy Following Pancreaticoduodenectomy | Patients who underwent surgical resection of pancreatic cancer and received intraoperative electrochemotherapy applied to the posterior resection surface. | 7 | 10 | 1 | 10 | 6 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatic fistula | Hepatobiliary disorders | Systematic Assessment | Chronic pancreatic fistula with sever complications and subsequently death (portal vein thrombosis, hepatic artery pseudoaneurysm, bleeding). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical wound infection | Surgical and medical procedures | Systematic Assessment |
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| Paralytic ileus | Gastrointestinal disorders | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
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| Paroxysmal atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Intraperitoneal hematoma | Surgical and medical procedures | Systematic Assessment |
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| Pancreatic fistula (Grade B) | Surgical and medical procedures | Systematic Assessment |
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Because this is a pilot study, the number of included patients is small (N=10), which represents the main limitation of the research. Due to the small sample size, it is not possible to draw conclusions regarding effectiveness; a larger sample and longer patient follow-up are required. The conclusion regarding safety would also need a larger patient cohort to strengthen our findings.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Žan Čebron | UMC Ljubljana | 0038615224788 | zan.cebron@kclj.si |
| Mar 6, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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