Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-31 @ 10:21 AM
Study NCT ID:
NCT03550560
Status:
UNKNOWN
Last Update Posted:
2018-06-08
First Post:
2018-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EUS-Guided Drainage of Refractory Malignant Ascites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-07', 'studyFirstSubmitDate': '2018-03-15', 'studyFirstSubmitQcDate': '2018-06-07', 'lastUpdatePostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of new evacuation paracentesis after the procedure.', 'timeFrame': 'At 1 week.', 'description': 'Paracentesis is an invasive technique that, by means of an abdominal percutaneous puncture, allows us to evacuate fluid from the peritoneal cavity. However, it only provides temporary improvement because the rapid recurrence of fluid usually occurs in about 72 hours.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.', 'timeFrame': 'At 1 week.', 'description': 'CTCAE is widely accepted throughout the oncology community as the standard classification and severity grading scale for adverse events in cancer therapy clinical trials and other oncology settings.'}, {'measure': 'Change in quality of life by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-palliative care (EORTC QLQ-C15-PAL)', 'timeFrame': 'From baseline at 1 week.', 'description': 'EORTC QLQ-C15-PAL is a questionnaire developed to assess the quality of life of palliative cancer care patients. It comprises 15 questions including two functional scales (physical function and emotional function), two multi-item symptom scales (fatigue and pain), and five single-item symptom scales (nausea and vomiting, dyspnea, insomnia, appetite loss, and constipation). Response options to these 14 items use a four-point Likert scale: 1 (not at all), 2 (a little), 3 (quite a bit), and 4 (very much). An additional item, global health/quality-of-life scale, uses a seven point numerical scale from 1 (very poor) to 7 (excellent). Higher scores for the functional scale and global health/quality-of-life scale indicate better quality of life. However, higher symptom scales indicate lower quality of life.'}, {'measure': 'Change in Dyspnea by The modified Medical Research Council (mMRC) Scale.', 'timeFrame': 'From baseline at 1 week.', 'description': "The mMRC scale is used to establish the severity of dyspnea attributable to the respiratory disease.\n\nThe mMRC is a self-administered questionnaire where the patient must choose one among five statements based on the perception of the patient in daily activities:\n\n0\\. Not troubled by breathlessness except on strenuous exercise.\n\n1. Short of breath when hurrying or walking up a slight hill.\n2. Walks slower than peers on level ground due to dyspnea, or must to stop for breath when walking at own pace.\n3. Stops for breath after walking about 100m or after a few minutes on level ground.\n4. Too breathless to leave the house, or breathless when dressing or undressing.\n\nAccording to the patient's response, dyspnea is classified as: 0. None, 1. Mild, 2. Moderate, 3. Severe and 4. Very severe."}, {'measure': 'Change in abdominal pain by The Visual Analogue Scale (VAS).', 'timeFrame': 'From baseline at 1 week.', 'description': 'VAS is a measurement instrument that permite to measure pain. The VAS used is a straight horizontal line of 100 mm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left (worst) to the right (best). Using a ruler, the score is determined by measuring the distance (mm) between the "no pain" anchor and the patient\'s mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.'}, {'measure': 'Change in abdominal circumference.', 'timeFrame': 'From baseline at 1 week.', 'description': 'Circumference in centimeters.'}, {'measure': 'Change in weight.', 'timeFrame': 'Form baseline at 1 week.', 'description': 'Weight in kilograms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endoscopic Ultrasound-Guided', 'EUS-Guided', 'Transgastric plastic prostheses'], 'conditions': ['Malignant Ascites']}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy and safety of drainage of refractory malignant ascites by endoscopic ultrasound-guided (EUS-Guided) implantation of plastic prostheses. Patients with cancer older than 18 years with a life expectancy of less than 6 months who undergo EUS-Guided will be included in the study.', 'detailedDescription': 'Malignant ascites is described as the presence of fluid in the abdominal cavity due to the presence of tumors. Its appearance is a predictor of worse prognosis in the evolution of malignant neoplasm and reduces the quality of life of patients.\n\nThe use of prostheses with drainage to the gastric cavity has shown good clinical results as the reduction of paracentesis evacuation needs. This achieves the reduction of hospital admissions and the improvement of the quality of life of the patient.\n\nIn order to verify the usefulness of this drainage technique, a prospective observational study has been designed. Patients with cancer over 18 years of age will be included, with a life expectancy of less than 6 months and who have undergone drainage of refractory malignant ascites through the implantation of plastic prostheses.\n\nParticipants receive the intervention in the same manner and intensity if they are not enrolled in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer patients in terminal phase with refractory malignant ascites', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cancer patients in terminal phase with refractory malignant ascites older 18 years of age\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Patients with a life expectancy greater than 6 months\n* Patients who are receiving cancer treatment for curative purposes or who suffer from a psychiatric disorder that prevents them from understanding and accepting the procedure\n* Patients who do not accept to participate in the study.'}, 'identificationModule': {'nctId': 'NCT03550560', 'briefTitle': 'EUS-Guided Drainage of Refractory Malignant Ascites', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Virgen Macarena'}, 'officialTitle': 'Drainage of Refractory Malignant Ascites by Endoscopic Ultrasound-guided (EUS-Guided) Implantation of Plastic Prostheses', 'orgStudyIdInfo': {'id': 'JBO-ECO-2017-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EUS-Guided drainage', 'description': 'Cancer patients in terminal phase with refractory malignant ascites', 'interventionNames': ['Procedure: EUS-Guided drainage']}], 'interventions': [{'name': 'EUS-Guided drainage', 'type': 'PROCEDURE', 'description': 'Drainage of refractory malignant ascites by endoscopic ultrasound-guided (EUS-Guided) implantation of plastic prostheses.', 'armGroupLabels': ['EUS-Guided drainage']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Secretaría Delos Clinical', 'role': 'CONTACT', 'email': 'secretaria@delosclinical.com', 'phone': '+34 954 001 079'}, {'name': 'Carlos García Perez', 'role': 'CONTACT', 'email': 'administracion.eecc.hvm.sspa@juntadeandalucia.es', 'phone': '+34 600 162 458'}], 'overallOfficials': [{'name': 'Rafael Romero Castro, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Virgen Macarena'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Virgen Macarena', 'class': 'OTHER'}, 'collaborators': [{'name': 'Delos Clinical', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}