Calcium Electroporation for Malignant Gastrointestinal Bleeding – a randomized trial

Phase 1

• Conditions: Malignant gastrointestinal bleeding; MedDRA version: 20.1Level: LLTClassification code 10017936Term: Gastrointestinal bleedingSystem Organ Class: 100000004856; MedDRA version: 12.0Level: HLGTClassification code 10007129Term: Cancer-related morbiditiesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-004624-41-DK
• Lead Sponsor: Zealand University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-05
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion criteria
•Patients must be mentally capable of understanding the information given.
•Patients must give written informed consent.
•Endoscopically assessable tumor for calcium electroporation.
•Men or women aged at least 18 years.
•Case reviewed by MDT (surgery, radiology, oncology).
•ASA class I-III (Classification of the American Society of Anesthesiology)
•Clinically significant GI bleeding, defined as one of the following:
oMelena
oHematochezia
oHematamesis
oSignificant anemia

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

Exclusion criteria
•Acute bleeding
•Hemodynamic instability (Heart rate >100 beats per minute and systolic blood pressure <90 mmHg)
•Bleeding from a non-malignant source
•Uncorrectable coagulation disorder.
•Patients with ICD or pacemaker units.
•Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments.
•Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this phase II, randomized controlled trial, is to evaluate the efficacy and long-term outcomes of calcium electroporation for clinically significant GI bleeding in non-curable cancer patients. Calcium electroporation will be compared with standard treatment options, including endoscopic interventions and radiotherapy. ;Secondary Objective: To investigate recurrent bleeding and overall survival after calcium electroporation;Primary end point(s): Primary endpoint <br>•Recurrence of bleeding<br>oDefined as clinically significant bleeding evaluated 4 weeks after study treatment <br><br>;Timepoint(s) of evaluation of this end point: After 4 weeks<br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints<br>•Elimination of the bleeding<br>oTreatment success will be defined as no bleeding >3 days after the treatment<br>•Recurrence of bleeding<br>oDefined as clinically significant bleeding >7 after study treatment <br>•Overall survival;Timepoint(s) of evaluation of this end point: Evaluated at 1 week, 4 weeks and 3 months. <br><br>Patients are followed until death