[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643037":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":35,"studyPopulation":27,"armGroups":36,"interventions":44,"overallOfficials":56,"centralContacts":61,"locations":27,"responsibleParty":70,"collaborators":27,"id":72,"slug":27,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":27,"enrollmentInfo":81,"targetDuration":27,"studyType":84,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":94,"whyStopped":27,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":27},{"fullName":5,"class":6},"Hospital del Rio Hortega","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"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.","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.",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"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.","Baseline (prior to the first CaEP treatment) and Week 4 (prior to the second CaEP treatment).",{"measure":19,"description":20,"timeFrame":12},"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.",{"measure":22,"description":23,"timeFrame":12},"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.",{"measure":25,"description":26,"timeFrame":12},"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.",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":31,"primaryPurpose":32,"observationalModel":27,"timePerspective":27,"maskingInfo":33},"NA","SINGLE_GROUP","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.\n\nParticipants 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.","SUPPORTIVE_CARE",{"masking":34,"maskingDescription":27,"whoMasked":27},"NONE","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.\n\nParticipants 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.\n\nPatient 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.\n\nStudy Population Adult patients (≥18 years) with histologically confirmed gastric cancer presenting with iron-deficiency anemia and\u002For gastrointestinal bleeding attributable to the primary tumor will be prospectively enrolled after providing written informed consent.\n\nThe study will be conducted in the Gastroenterology Departments of participating hospitals.\n\nSample 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.\n\nIntervention Procedures Baseline Assessment\n\nBefore treatment, participants will undergo:\n\n* Clinical evaluation and medical history review.\n* Symptom assessment, including pain evaluation using a visual analogue scale (VAS).\n* Quality-of-life assessment using the EORTC QLQ-C30 questionnaire.\n* Nutritional assessment, including anthropometric measurements and laboratory testing.\n* Complete blood analysis, including hemoglobin, hematocrit, albumin, prealbumin, iron studies, vitamin levels, electrolytes, and metabolic profile.\n* Endoscopic tumor assessment with photographic documentation and tumor size estimation.\n\nTumor 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.\n\nCalcium Electroporation Procedure The procedure will be performed on an outpatient basis under deep sedation with standard monitoring and supplemental oxygen.\n\nFollowing endoscopic evaluation of the lesion, intratumoral calcium gluconate (220 mM; 9 mg\u002FmL) 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.\n\nElectroporation 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.\n\nAfter treatment, patients will remain under observation for 60-120 minutes for monitoring of immediate adverse events, including pain, bleeding, nausea, or perforation.\n\nFollow-up A telephone safety assessment will be conducted 1 week after each treatment session.\n\nThe second CaEP treatment will be performed 4 weeks after the first procedure and will include repeat clinical assessment, laboratory evaluation, and biological sample collection.\n\nSubsequently, 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.\n\nFrom month 3 onward, follow-up assessments will occur every 12 weeks (weeks 12, 24, 36, and 48) and will include:\n\n* Clinical evaluation.\n* Laboratory testing.\n* Symptom assessment.\n* EORTC QLQ-C30 quality-of-life questionnaire.\n* Upper gastrointestinal endoscopy.\n* Computed tomography (CT) imaging. Additional CaEP treatments may be offered in cases of recurrent tumor-related bleeding or anemia after exclusion of alternative causes. Retreatment may be considered in patients experiencing a decrease in hemoglobin of ≥2 g\u002FdL from previous assessments or clinical evidence of recurrent gastrointestinal bleeding.",[37],{"label":38,"type":39,"description":40,"interventionNames":41},"endoscopic calcium electroporation","EXPERIMENTAL","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.",[42,43],"Procedure: Endoscopy Calcium Electroporation","Device: Endoscopy Calcium electroporation",[45,50],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":27},"PROCEDURE","Endoscopy Calcium Electroporation","Calcium Electroporation Procedure\n\nThe procedure will be performed on an outpatient basis under deep sedation with standard monitoring and supplemental oxygen.\n\nFollowing endoscopic evaluation of the lesion, intratumoral calcium gluconate (220 mM; 9 mg\u002FmL) 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.\n\nElectroporation 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.",[38],{"type":51,"name":52,"description":48,"armGroupLabels":53,"otherNames":54},"DEVICE","Endoscopy Calcium electroporation",[38],[55],"Endoscopic electrochemotherapy",[57],{"name":58,"affiliation":59,"role":60},"Mª Henar Núñez Rodríguez","Digestive Department, Hospital Rio Hortega, Valladolid, Sapin","PRINCIPAL_INVESTIGATOR",[62,68],{"name":63,"role":64,"phone":65,"phoneExt":66,"email":67},"Mª Henar Núñez Rodríguez, MD PhD","CONTACT","34 983 420 400","84433","henarnrod@yahoo.es",{"name":69,"role":64,"phone":65,"phoneExt":66,"email":67},"Mª Henar Núñez Rodriguez, MD PhD",{"type":60,"investigatorFullName":69,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Digestive Disease Doctor, MD PhD","100643037",false,"NCT07647731","Endoscopic Calcium Electroporation in Gastric Tumors","Evaluation of Endoscopic Calcium Electroporation in Gastric Tumors: A Minimally Invasive Treatment Strategy","GASTRIC-CaEP","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\n* Age ≥18 years.\n* Histologically confirmed gastric malignancy.\n* Presence of anemia and\u002For gastrointestinal bleeding secondary to gastric cancer.\n* Ability and willingness to provide written informed consent.\n\nIn addition, participants must meet at least one of the following conditions:\n\n* Patients considered unsuitable for surgical and\u002For oncological treatment with curative or palliative intent due to advanced age, frailty, or significant comorbidities (Charlson Comorbidity Index ≥3 and\u002For ECOG Performance Status ≥2), following multidisciplinary team assessment.\n* Patients with metastatic disease receiving palliative systemic therapy in whom CaEP is indicated for symptomatic control of tumor-related gastrointestinal bleeding.\n* Patients receiving neoadjuvant therapy who develop tumor-related gastrointestinal bleeding requiring bleeding control to avoid interruption of systemic treatment prior to surgery.\n* Patients who decline surgical and\u002For oncological treatment when CaEP is considered appropriate for symptomatic control of gastrointestinal bleeding.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded:\n\n* Pregnancy or breastfeeding.\n* Presence of an endoluminal prosthesis within the intended treatment area.\n* Implanted electrical devices (e.g., pacemakers, implantable cardioverter-defibrillators) when temporary deactivation is not feasible or procedural safety cannot be guaranteed.\n* Uncorrectable coagulation disorders.\n* Medical contraindication to deep sedation or therapeutic upper gastrointestinal endoscopy.\n* Estimated life expectancy of less than 1 month.\n* Refusal or inability to provide informed consent","ALL","18 Years",{"count":82,"type":83},28,"ESTIMATED","INTERVENTIONAL",[29],"Brief Summary Background\n\nGastric 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.\n\nDespite 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.\n\nIn 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.\n\nPrimary Objective\n\nTo 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.\n\nStudy Design\n\nThis is a multicenter, non-randomized, non-pharmacological interventional study with longitudinal follow-up.\n\nThe 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.\n\nPrimary Outcome Measure\n\nClinical control of gastrointestinal bleeding secondary to gastric neoplasia.\n\nStudy Population\n\nPatients with histologically confirmed gastric cancer who present with gastrointestinal bleeding symptoms or secondary anemia will be prospectively enrolled.\n\nEligible participants will include patients who are candidates for palliative treatment, either as monotherapy or in combination with systemic medical treatment and\u002For radiotherapy. Patients experiencing tumor-related bleeding during neoadjuvant treatment prior to surgery may also be included.\n\nEstimated Enrollment\n\nA total sample size of 25 evaluable patients is required. Assuming a 10% loss to follow-up, the planned enrollment is 28 patients.",[88],"Calcium Electroporation for Hemostasis in Gastric Neoplasms",[90,91,92,93],"BLEEDING","CALCIUM ELECTROPORATION","gastric neoplasms","hemostasis","NOT_YET_RECRUITING","2026-06-09",{"date":97,"type":98},"2026-06-15","ACTUAL",{"date":100,"type":83},"2026-06",{"date":102,"type":83},"2031-12",{"name":5,"class":6}]