Malignant gastrointestinal bleeding MedDRA version: 20.1 Level: LLT Classification code 10017936 Term: Gastrointestinal bleeding System Organ Class: 100000004856 MedDRA version: 12.0 Level: HLGT Classification code 10007129 Term: Cancer-related morbidities System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Calcium Chloride SAD
Pharmaceutical Form: Solution for injection
Other descriptive name: CALCIUM CHLORIDE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Concen
Sponsors
Zealand University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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: o Melena o Hematochezia o Hematamesis o Significant 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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 • Recurrence of bleeding o Defined as clinically significant bleeding evaluated 4 weeks after study treatment ;Timepoint(s) of evaluation of this end point: After 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints • Elimination of the bleeding o Treatment success will be defined as no bleeding >3 days after the treatment • Recurrence of bleeding o Defined as clinically significant bleeding >7 after study treatment • Overall survival;Timepoint(s) of evaluation of this end point: Evaluated at 1 week, 4 weeks and 3 months. Patients are followed until death | — |
Countries
Denmark
Contacts
Public ContactDepartment of Surgery
Zealand University Hospital
Outcome results
None listed