Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-02 @ 12:16 AM
Study NCT ID:
NCT05128604
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2021-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005763', 'term': 'Gastroenterostomy'}, {'id': 'D019160', 'term': 'Endosonography'}], 'ancestors': [{'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-09-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2021-07-11', 'studyFirstSubmitQcDate': '2021-11-09', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety introduction of EUS-gastroenterostomy', 'timeFrame': '12 months', 'description': 'To determine the safety of this interventional technique, measuring prospectively the adverse events and incidents after after a learning project for helping to introduce this technique.'}], 'secondaryOutcomes': [{'measure': 'Learning curve', 'timeFrame': '12 months', 'description': 'To assess the number of procedures related to a competence in the EUS-Gastroenterostomy'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['endoscopic ultrasound', 'gastroenterostomy', 'lumen apposing stent'], 'conditions': ['Endoscopic Surgical Procedure', 'Safety', 'Training']}, 'descriptionModule': {'briefSummary': "This is project of help and support for the introduction of the GASTROENTEROANASTOMOSIS technique guided by ENDOSCOPIC -ULTRASOUND (EUS-GE) in centers in Catalonia, facilitating a teacher training.\n\nThe main objective is facilitate a safe introduction of the technique, limiting technical failures, and if necessary, support in rescue techniques.\n\nThe goal of this interventional study is to assess the impact of a teaching and on live-support model in the introduction of the gastroenteroanastomosis technique, evaluating its effects in safety and the learning curve.\n\nregarding the results in safety and learning curve of for the introduction \\[type of study: observational study or clinical trial\\] is to \\[learn about, test, compare etc.\\] in \\[describe participant population/health conditions\\]. The main question\\[s\\] it aims to answer are:\n\n* \\[question 1\\]\n* \\[question 2\\] Participants will \\[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\\]. If there is a comparison group: Researchers will compare \\[insert groups\\] to see if \\[insert effects\\]."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with sympotmatic Gastric outlet obstruction (GOO) related to malignant or notn-malignant conditions.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 years or more\n* Gastric outlet obstruction (GOO) caused by passable /unpassable stenosis in the antrum-duodenal region, to malignant or non-malignant conditions\n* Patient capable of understanding and signing informed consent form\n* Patient understanding the type of study and complying with the follow-up of complementary tests during the study's duration\n\nExclusion Criteria:\n\n* Massive ascites.\n* Complete stenosis\n* Failure to sign informed consent form\n* Patients with intellectual handicap who are unable to understand the nature and possible consequences of the study, unless there is a competent legal representative\n* Patients unable to adhere to subsequent follow-up requirements\n* Severe coagulation disorder: INR \\> 1.5 not correctible with administration of plasma and/or platelets \\< 50,000/mm3"}, 'identificationModule': {'nctId': 'NCT05128604', 'acronym': 'GESICA', 'briefTitle': 'Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari de Bellvitge'}, 'officialTitle': 'Introduction Of Endoscopic Ultrasound-Guided Gastroenterostomy Based On A Learning Protocol And Prospective Registry.', 'orgStudyIdInfo': {'id': 'GESICA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gastroenterostomy', 'type': 'DEVICE', 'otherNames': ['Endoscopic ultrasound', 'Lumen apposing stent'], 'description': 'Endoscopic ultrasound guided gastroenterostomy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona, Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan A Colán, MD', 'role': 'CONTACT', 'email': 'jacolanh.germanstrias@gencat.cat', 'phone': '00 (34) 934 65 12 00'}, {'role': 'CONTACT', 'phone': '00 (34) 934 65 12 00'}], 'facility': 'Hospital Universitari Germans Trias i Pujol (Can Ruti)', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona, Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Joan B Gornals, MD, PhD', 'role': 'CONTACT', 'email': 'jgornals@bellvitgehospital.cat', 'phone': '+34 93 260 76 82', 'phoneExt': '2624'}, {'name': 'Daniel Luna, MD', 'role': 'CONTACT', 'email': 'danii.luna23@gmail.com', 'phone': '+34 93 260 76 82', 'phoneExt': '2624'}, {'name': 'Claudia F. Consiglieri, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Daniel Luna, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '08221', 'city': 'Terrassa', 'state': 'Barcelona, Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Carme Loras, MD, PhD', 'role': 'CONTACT', 'email': 'clorasalas@gmail.com', 'phone': '00 (34) 937 36 50 50'}, {'role': 'CONTACT', 'phone': '00 (34) 937 36 50 50'}, {'name': 'Xavi Andújar, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Universitari Mútua de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '08041', 'city': 'Barcelona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Charlie guarner Argente, MD, PhD', 'role': 'CONTACT', 'email': 'CGuarnerA@santpau.cat', 'phone': '00 (34) 932919000'}, {'role': 'CONTACT', 'phone': '00 (34) 932919000'}], 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Luis Barranco, MD', 'role': 'CONTACT', 'email': 'luisbarranco@gmail.com', 'phone': '00 (34) 932 48 30 00'}, {'role': 'CONTACT', 'phone': '00 (34) 932 48 30 00'}], 'facility': 'Hospital Del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '17007', 'city': 'Girona', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Carlos Huertas, MD, PhD', 'role': 'CONTACT', 'email': 'chuertas.girona.ics@gencat.cat', 'phone': '00(34) 972 94 02 00'}, {'role': 'CONTACT', 'phone': '00(34) 972 94 02 00'}], 'facility': 'Hospital Universitari de Girona Doctor Josep Trueta', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}], 'centralContacts': [{'name': 'Joan Gornals, MD, PhD', 'role': 'CONTACT', 'email': 'jbgornals@bellvitgehospital.cat', 'phone': '+34932607682'}], 'overallOfficials': [{'name': 'Joan B Gornals, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitari de Bellvitge - IDIBELL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitari de Bellvitge', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Mutua de Terrassa', 'class': 'OTHER'}, {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, {'name': 'Hospital del Mar', 'class': 'OTHER'}, {'name': 'Germans Trias i Pujol Hospital', 'class': 'OTHER'}, {'name': 'Hospital Universitari de Girona Dr. Josep Trueta', 'class': 'UNKNOWN'}, {'name': 'Hospital de Granollers', 'class': 'OTHER'}, {'name': 'Hospital General Universitario Gregorio Marañon', 'class': 'OTHER'}, {'name': 'Hospital Universitario Virgen Macarena', 'class': 'OTHER'}, {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, {'name': 'Hospital Universitario del Sureste', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Director of Endoscopy Programme', 'investigatorFullName': 'Joan B Gornals', 'investigatorAffiliation': 'Hospital Universitari de Bellvitge'}}}}