Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer
Phase: NA
Conditions: Pancreas Cancer
Sponsor: University Medical Centre Ljubljana

Study Protocol with Statistical Analysis Plan 
PanECT Study 
 
Study Title 
Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence 
Rate in Pancreatic Cancer (PanECT Study) 
 
ClinicalTrials.gov Identifier: NCT04281290 
Institution: University Medical Centre Ljubljana in collaboration with Institute of Oncology 
Ljubljana 
Protocol updated: 6th of march 2026 
 
1. Background and Rationale 
Pancreatic cancer remains one of the most lethal malignancies, with poor long-term 
survival despite improvements in surgical techniques and systemic therapies. Local 
recurrence occurs in approximately 30% of patients after surgical resection, contributing 
significantly to disease progression and mortality. 
Electrochemotherapy (ECT) is a treatment modality that combines the administration of 
cytotoxic agents with locally delivered electric pulses that temporarily permeabilize cell 
membranes, thereby enhancing drug uptake. Bleomycin is commonly used due to its 
strong potentiation when combined with electroporation. 
The posterior resection margin in pancreatic head carcinoma is located near major 
vascular structures and represents a frequent site of local recurrence. Application of 
intraoperative electrochemotherapy to this area may improve local disease control without 
causing significant damage to surrounding vessels. 
 
The PanECT study was therefore designed to evaluate the safety, feasibility, and 
preliminary efficacy of intraoperative electrochemotherapy applied to the posterior 
pancreatic resection surface following surgical resection. 
 
The methodology and preliminary clinical results of the PanECT study have been previously 
reported in a peer-reviewed publication. Intraoperative electrochemotherapy applied to 
the posterior pancreatic resection surface demonstrated feasibility and acceptable safety 
in patients undergoing surgical treatment for pancreatic cancer. 
 
2. Study Objectives 
Primary Objective 
To evaluate the safety and feasibility of intraoperative electrochemotherapy of the 
posterior resection surface following pancreaticoduodenectomy. 
• To assess postoperative complications according to the Clavien-Dindo classification. 

• To evaluate treatment tolerance and quality of life. 
 
Secondary Objectives 
• To evaluate local recurrence rate after treatment. 
• To evaluate disease-free survival (DFS). 
• To evaluate overall survival (OS). 
 
3. Study Design 
Prospective Phase I pilot clinical study. 
Patients undergoing surgical resection for pancreatic head carcinoma will receive 
additional intraoperative electrochemotherapy applied to the posterior resection surface. 
 
Study phases: 
Phase I – safety and feasibility evaluation (10 patients)  
 
4. Study Population 
Inclusion Criteria 
• Age ≥ 18 years 
• Histologically or radiologically confirmed resectable pancreatic ductal 
adenocarcinoma 
• Candidate for pancreaticoduodenectomy 
• ECOG performance status 0–2 
• Adequate organ function 
• Written informed consent 
 
Exclusion Criteria 
• Metastatic disease 
• Severe cardiac arrhythmias 
• Known hypersensitivity to bleomycin 
• Pregnancy or breastfeeding 
• Severe comorbid conditions preventing surgery 
 
5. Treatment Procedure 
After surgical removal of the pancreatic tumor, intraoperative electrochemotherapy will be 
performed on the posterior resection surface. 
Bleomycin will be administered intravenously as a bolus at a dose of 15 mg/m². 
Electric pulses will be delivered 8–28 minutes after drug administration using a 
Cliniporator device with plate electrodes positioned between the following anatomical 
landmarks: 
• lateral border of the inferior vena cava 

• resection margin of the common hepatic duct 
• truncus coeliacus 
• pancreatic resection surface 
• level of the left renal vein 
 
Each electrode application will deliver: 
• 8 electric pulses 
• duration 100 μs 
• frequency 5 kHz 
• amplitude 960 V 
Electric pulse delivery will be synchronized with ECG signals using the AccuSync ECG 
triggering device to prevent delivery during the vulnerable period of the cardiac cycle. 
 
6. Postoperative Monitoring 
Patients will be closely monitored postoperatively. 
During the first postoperative days, patients will be treated in the intensive care unit where 
vital parameters including ECG will be continuously monitored. 
Laboratory tests will include: 
• hemogram 
• electrolytes 
• inflammatory markers 
• liver function tests 
Amylase and lipase levels from abdominal drains will be measured on postoperative days 
3 and 7 to detect pancreatic fistula. 
Doppler ultrasound will be performed approximately 7 days after surgery to evaluate blood 
flow through the hepatic artery and portal vein. 
 
7. Follow-Up 
Patients will undergo regular follow-up visits including: 
• clinical examination 
• laboratory tests 
• tumor markers (CA19-9 and CEA) 
• ultrasound or CT imaging 
 
Follow-up schedule: 
• 1 month after surgery 
• 3 months 
• 6 months 
• every 6 months thereafter 
These evaluations will be used to detect early local recurrence and assess long-term 
treatment outcomes. 

 
8. Outcome Measures 
Primary Outcome 
Safety and feasibility of intraoperative electrochemotherapy, measured by postoperative 
complications within 30 days after surgery. 
Complications will be graded according to the Clavien-Dindo classification. 
 
Secondary Outcomes 
• Disease-free survival 
• Overall survival 
• Local recurrence rate 
• Quality of life 
• Treatment tolerance 
 
9. Statistical Analysis Plan 
This study is designed as an exploratory pilot study. 
The planned sample size of 10 patients is based on feasibility considerations rather than 
formal power calculations. 
 
Continuous variables will be summarized using: 
• mean ± standard deviation, or 
• median with interquartile range. 
Categorical variables will be summarized using frequencies and percentages. 
Disease-free survival and overall survival will be estimated using the Kaplan–Meier 
method. 
Postoperative complication rates will be analyzed descriptively. 
 
10. Ethical Considerations 
The study was approved by the National Medical Ethics Committee of the Republic of 
Slovenia. 
 
All patients provided written informed consent prior to participation. 
The study is conducted in accordance with: 
• the Declaration of Helsinki 
• Good Clinical Practice guidelines 
 

11. Publication 
The preliminary results of this clinical study have been published in the following peer-
reviewed article: 
 
Čebron Ž, Djokić M, Petrič M, Čemažar M, Bošnjak M, Serša G, Trotovšek 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. PMID: 37748261.