Trial Outcomes & Findings for Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer (PanECT Study) (NCT NCT04281290)
NCT ID: NCT04281290
Last Updated: 2026-03-27
Results Overview
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.
ACTIVE_NOT_RECRUITING
NA
10 participants
7 days after operation
2026-03-27
Participant Flow
Participant milestones
| Measure |
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)
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|---|---|
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Overall Study
STARTED
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10
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|
Overall Study
COMPLETED
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3
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
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)
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|---|---|
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Overall Study
Death
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7
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Baseline Characteristics
Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer (PanECT Study)
Baseline characteristics by cohort
| Measure |
Experimental Group
n=10 Participants
According to the study protocol 10 patients were enrolled in the study.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=56 Participants
|
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Age, Categorical
Between 18 and 65 years
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3 Participants
n=56 Participants
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Age, Categorical
>=65 years
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7 Participants
n=56 Participants
|
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Age, Continuous
|
71 Years
STANDARD_DEVIATION 10 • n=56 Participants
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Sex: Female, Male
Female
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6 Participants
n=56 Participants
|
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Sex: Female, Male
Male
|
4 Participants
n=56 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=56 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants
|
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Region of Enrollment
Slovenia
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10 participants
n=56 Participants
|
PRIMARY outcome
Timeframe: 7 days after operationPopulation: All the enrolled patients were included in analysis.
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.
Outcome measures
| Measure |
Experimental Group
n=10 Participants
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)
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|---|---|
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Incidence of Postprocedural Complications for Evaluation of Feasibility and Safety
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4 Participants
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SECONDARY outcome
Timeframe: 1, 3, 6, 12, 18 and 24 months after operationDisease-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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the time of surgical treatment until 5 years after surgeryOverall 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.
Outcome measures
Outcome data not reported
Adverse Events
Experimental Group - Intraoperative Electrochemotherapy Following Pancreaticoduodenectomy
Serious adverse events
| Measure |
Experimental Group - Intraoperative Electrochemotherapy Following Pancreaticoduodenectomy
n=10 participants at risk
Patients who underwent surgical resection of pancreatic cancer and received intraoperative electrochemotherapy applied to the posterior resection surface.
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|---|---|
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Hepatobiliary disorders
Pancreatic fistula
|
10.0%
1/10 • Number of events 1 • 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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Other adverse events
| Measure |
Experimental Group - Intraoperative Electrochemotherapy Following Pancreaticoduodenectomy
n=10 participants at risk
Patients who underwent surgical resection of pancreatic cancer and received intraoperative electrochemotherapy applied to the posterior resection surface.
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|---|---|
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Surgical and medical procedures
Surgical wound infection
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10.0%
1/10 • Number of events 1 • 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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Gastrointestinal disorders
Paralytic ileus
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10.0%
1/10 • Number of events 1 • 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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Vascular disorders
Deep vein thrombosis
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10.0%
1/10 • Number of events 1 • 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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Cardiac disorders
Paroxysmal atrial fibrillation
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10.0%
1/10 • Number of events 1 • 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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Surgical and medical procedures
Intraperitoneal hematoma
|
10.0%
1/10 • Number of events 1 • 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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Surgical and medical procedures
Pancreatic fistula (Grade B)
|
10.0%
1/10 • Number of events 1 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place