An interventional study of Endoscopy Calcium Electroporation and Endoscopy Calcium electroporation in Calcium Electroporation for Hemostasis in Gastric Neoplasms, sponsored by Hospital del Rio Hortega. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Hospital del Rio Hortega · Not applicable, Interventional, and Supportive care
Brief Summary Background
Gastric cancer (GC) remains a major global public health challenge, ranking as the fifth most common malignancy worldwide and the third leading cause of cancer-related mortality. In 2018, approximately 1 million new cases and 783,000 deaths were reported globally. The median age at diagnosis is around 60 years, with relatively few cases occurring in younger patients.
Despite advances in systemic therapies, up to 60% of patients are diagnosed with advanced-stage disease, and approximately 20% present with significant comorbidities that limit available treatment options. This highlights the need for effective, safe, and well-tolerated therapeutic alternatives, particularly for frail patients and those with advanced disease.
In this context, calcium electroporation (CaEP) has emerged as a novel therapeutic approach with the potential to address an important unmet clinical need. CaEP is a local, minimally invasive treatment that may provide effective control of debilitating symptoms such as tumor-related gastrointestinal bleeding, while improving patients' functional status and quality of life. Importantly, these benefits may be achieved without the additional morbidity and mortality associated with more invasive therapeutic interventions. The implementation of CaEP could represent a significant advance in the management of gastric cancer, particularly in patients with limited treatment options.
Primary Objective
To evaluate the efficacy and safety of calcium electroporation (CaEP) in controlling gastrointestinal bleeding secondary to gastric cancer in patients undergoing palliative treatment, either in combination with systemic therapy or in clinical situations where control of tumor-related bleeding is required.
Study Design
This is a multicenter, non-randomized, non-pharmacological interventional study with longitudinal follow-up.
The intervention consists of two scheduled sessions of endoscopic calcium electroporation (CaEP). The second procedure will be performed 4 weeks after the first treatment unless contraindicated for clinical reasons.
Primary Outcome Measure
Clinical control of gastrointestinal bleeding secondary to gastric neoplasia.
Study Population
Patients with histologically confirmed gastric cancer who present with gastrointestinal bleeding symptoms or secondary anemia will be prospectively enrolled.
Eligible participants will include patients who are candidates for palliative treatment, either as monotherapy or in combination with systemic medical treatment and/or radiotherapy. Patients experiencing tumor-related bleeding during neoadjuvant treatment prior to surgery may also be included.
Estimated Enrollment
A total sample size of 25 evaluable patients is required. Assuming a 10% loss to follow-up, the planned enrollment is 28 patients.
Study Design This is a prospective, multicenter, non-randomized, non-pharmacological interventional study with longitudinal follow-up designed to evaluate the efficacy and safety of endoscopic calcium electroporation (CaEP) for the management of tumor-related gastrointestinal bleeding in patients with gastric cancer.
Participants will undergo two scheduled sessions of endoscopic calcium electroporation. The second treatment session will be performed 4 weeks after the initial procedure unless a clinical or technical contraindication arises.
Patient recruitment and follow-up are planned from JUNE 2026 through May 2028. Data analysis and dissemination of results will take place between June 2028 and December 2028.
Study Population Adult patients (≥18 years) with histologically confirmed gastric cancer presenting with iron-deficiency anemia and/or gastrointestinal bleeding attributable to the primary tumor will be prospectively enrolled after providing written informed consent.
The study will be conducted in the Gastroenterology Departments of participating hospitals.
Sample Size Based on previously published data suggesting a 90% improvement in quality of life and reduction in transfusion requirements following calcium electroporation, a clinically meaningful improvement of 20% was assumed. Using a two-sided alpha error of 0.05 and a statistical power of 80%, the required sample size was calculated as 25 evaluable patients. Allowing for an anticipated 10% loss to follow-up, the target enrollment is 28 participants.
Intervention Procedures Baseline Assessment
Before treatment, participants will undergo:
Tumor biopsies, non-tumoral gastric mucosal biopsies (when technically feasible), and peripheral blood samples will be collected before the first treatment and again prior to the second treatment at week 4.
Calcium Electroporation Procedure The procedure will be performed on an outpatient basis under deep sedation with standard monitoring and supplemental oxygen.
Following endoscopic evaluation of the lesion, intratumoral calcium gluconate (220 mM; 9 mg/mL) will be injected using a 23-gauge needle. The administered volume will be calculated according to the European Standard Operating Procedures of Electrochemotherapy (ESOPE) guidelines and adjusted to tumor size.
Electroporation will then be performed using the EndoVE® device connected to the distal end of the endoscope and the ePORE® pulse generator. Electrical pulses will be delivered to cover the entire tumor surface whenever technically feasible. Procedural parameters, including treated tumor percentage, number of pulses, impedance, and applied voltage, will be recorded.
After treatment, patients will remain under observation for 60-120 minutes for monitoring of immediate adverse events, including pain, bleeding, nausea, or perforation.
Follow-up A telephone safety assessment will be conducted 1 week after each treatment session.
The second CaEP treatment will be performed 4 weeks after the first procedure and will include repeat clinical assessment, laboratory evaluation, and biological sample collection.
Subsequently, patients will undergo monthly follow-up visits (in-person or by telephone, according to clinical status) to record bleeding episodes, transfusion requirements, hospital admissions, and clinical outcomes.
From month 3 onward, follow-up assessments will occur every 12 weeks (weeks 12, 24, 36, and 48) and will include:
1,383 studies on the registry are indexed under Hemorrhage; 244 are open to participants now.
This study's planned enrollment of 28 is below the median of 102 across 926 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Hospital del Rio Hortega is the lead sponsor of 27 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all of the following criteria:
In addition, participants must meet at least one of the following conditions:
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo two scheduled sessions of endoscopic calcium electroporation. The second treatment session will be performed 4 weeks after the initial procedure unless a clinical or technical contraindication arises.
Procedure: Endoscopy Calcium Electroporation · Device: Endoscopy Calcium electroporation
Calcium Electroporation Procedure The procedure will be performed on an outpatient basis under deep sedation with standard monitoring and supplemental oxygen. Following endoscopic evaluation of the lesion, intratumoral calcium gluconate (220 mM; 9 mg/mL) will be injected using a 23-gauge needle. The administered volume will be calculated according to the European Standard Operating Procedures of Electrochemotherapy (ESOPE) guidelines and adjusted to tumor size. Electroporation will then be performed using the EndoVE® device connected to the distal end of the endoscope and the ePORE® pulse generator. Electrical pulses will be delivered to cover the entire tumor surface whenever technically feasible. Procedural parameters, including treated tumor percentage, number of pulses, impedance, and applied voltage, will be recorded.
Calcium Electroporation Procedure The procedure will be performed on an outpatient basis under deep sedation with standard monitoring and supplemental oxygen. Following endoscopic evaluation of the lesion, intratumoral calcium gluconate (220 mM; 9 mg/mL) will be injected using a 23-gauge needle. The administered volume will be calculated according to the European Standard Operating Procedures of Electrochemotherapy (ESOPE) guidelines and adjusted to tumor size. Electroporation will then be performed using the EndoVE® device connected to the distal end of the endoscope and the ePORE® pulse generator. Electrical pulses will be delivered to cover the entire tumor surface whenever technically feasible. Procedural parameters, including treated tumor percentage, number of pulses, impedance, and applied voltage, will be recorded.
Also known as: Endoscopic electrochemotherapy
Proportion of participants achieving clinical hemostasis
Number of participants with episodes of hematemesis, melena, or hematochezia recorded during follow-up, as assessed by clinical evaluation and medical record review.
Time frame: From the first CaEP treatment through 24 months of follow-up, including monthly assessments after the two scheduled procedures and quarterly assessments from Month 3 onward.
Differential protein expression in tumor tissue and peripheral blood following calcium electroporation (CaEP).
To identify differentially expressed proteins in tumor biopsy specimens and peripheral blood samples and to evaluate changes in protein expression profiles following treatment with calcium electroporation.
Time frame: Baseline (prior to the first CaEP treatment) and Week 4 (prior to the second CaEP treatment).
Need for Rescue Hemostatic Intervention
Percentage of participants requiring additional endoscopic, radiological, or surgical hemostatic treatment for recurrent gastric tumor-related bleeding during follow-up.
Time frame: From the first CaEP treatment through 24 months of follow-up, including monthly assessments after the two scheduled procedures and quarterly assessments from Month 3 onward.
Change From Baseline in Maximum Tumor Diameter Measured by Computed Tomography
Change in maximum tumor diameter (mm) from baseline to follow-up, measured on contrast-enhanced computed tomography scans according to RECIST 1.1 criteria.
Time frame: From the first CaEP treatment through 24 months of follow-up, including monthly assessments after the two scheduled procedures and quarterly assessments from Month 3 onward.
Change From Baseline in Endoscopic Tumor Size
Change in the maximum endoscopic tumor diameter (mm) from baseline to follow-up, measured during upper gastrointestinal endoscopy using endoscopic size estimation and photographic documentation.
Time frame: From the first CaEP treatment through 24 months of follow-up, including monthly assessments after the two scheduled procedures and quarterly assessments from Month 3 onward.
No study locations are listed for this record.
Plan to share: Yes — Demographic characteristics (e.g., age and sex). Baseline clinical characteristics, including ECOG Performance Status, Charlson Comorbidity Index, and disease stage. Laboratory parameters, including hematological, biochemical, and nutritional markers collected according to the study protocol. Symptom and quality-of-life assessments, including EORTC QLQ-C30 and Visual Analog Scale (VAS) scores. Tumor characteristics and endoscopic findings. Treatment-related data, including calcium electroporation (CaEP) procedural parameters, calcium dose administered, number of treatment sessions, and technical treatment characteristics. Clinical outcomes, including control of tumor-related gastrointestinal bleeding, transfusion requirements, hospital admissions, adverse events, progression, and survival outcomes. De-identified molecular, proteomic, and biomarker data generated from tumor tissue, non-tumoral gastric mucosa, and peripheral blood samples.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be available beginning 6-12 months after publication of the primary study results and will remain available for at least 5 years.
Access criteria: Access to de-identified individual participant data will be granted to qualified researchers upon submission of a methodologically sound research proposal. Requests will be reviewed by the study investigators and must comply with applicable ethical, legal, and data protection requirements. Data sharing agreements may be required before access is granted.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital del Rio Hortega