Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-02 @ 3:41 PM
Study NCT ID:
NCT06899269
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-27
First Post:
2025-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SPAROBOPAN Project (Spanish Registry of Robotic Pancreatic Surgery)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2025-03-14', 'studyFirstSubmitQcDate': '2025-03-21', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': '90 postoperative days', 'description': 'Clavien-Dindo Classification'}, {'measure': 'Postoperative complications', 'timeFrame': '90 postoperative days', 'description': 'CCI® (Comprehensive Complication Index). 0-100%. 100% represents the death of the patient.'}, {'measure': 'Number of robotic procedures', 'timeFrame': '1 year', 'description': 'Number of robotic pancreatic procedures'}], 'secondaryOutcomes': [{'measure': 'Experience of each group in robotic pancreatic surgery', 'timeFrame': '1 year', 'description': 'Questonnaire answering the number of robotic procedures in 2024.'}, {'measure': 'Textbook outcome', 'timeFrame': '1 year', 'description': 'Composite measure: No reintervention, no major complications, no readmission, no pancreatic leak B/C, no mortality and no prolongued hospital stay'}, {'measure': 'Total survival', 'timeFrame': '3 years', 'description': 'survival after surgery in months'}, {'measure': 'Disease-free survival', 'timeFrame': '3 years', 'description': 'Time from surgery to recurrence'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Robotic Surgical Procedures', 'Pancreatic Diseases']}, 'descriptionModule': {'briefSummary': 'Pancreatic robotic surgery (PRS) has moved from an almost testimonial procedure to a moment of expansion that is not yet clearly defined. In the pioneering centres, the results achieved are superior to those of open surgery. At present, it is not known how many centres perform CRP, what type of operations they perform, what percentage of the total number of pancreatic operations CRP represents and what results are obtained. The aim of our project is to establish a national multicentre registry of robotic pancreatic surgery that will allow us to answer all these questions.\n\nMethodology: This is a one-year prospective multicentre registry involving all general and digestive surgery units in Spain that have a DaVinci robotic platform and wish to participate and perform robotic pancreatectomies.\n\nAll adult patients undergoing robotic pancreatectomy at participating Spanish centres who meet the inclusion criteria will be included. The registry will be open until 31 March 2026 to include post-operative morbidity and mortality at 90 days. The number of pancreatic surgeries performed in that centre during the same period will be counted to determine the percentage of robotic pancreatic surgery per centre. Intraoperative complications will be measured according to the Satava classification modified by Halls et al. Postoperative complications will be classified according to the Clavien-Dindo classification and the CCI (Comprehensive Complication Index). Pancreatic fistula, postoperative bleeding and delayed gastric emptying were classified according to the ISGPS classification and biliary fistula according to the ISGLS classification.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient who will undergo robotic pancreatic resections', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* robotic pancreatic resections\n* Asa I-III\n* Signed informed consent\n\nExclusion Criteria:\n\n* Less than 18 years old.\n* ASA IV'}, 'identificationModule': {'nctId': 'NCT06899269', 'acronym': 'SPAROBOPAN', 'briefTitle': 'SPAROBOPAN Project (Spanish Registry of Robotic Pancreatic Surgery)', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario de Alicante'}, 'officialTitle': 'Proyecto SPAROBOPAN (Registro Nacional De Cirugía Róbotica Pancreática)', 'orgStudyIdInfo': {'id': '2024-089'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Duoneopancreatectomy', 'description': 'Resection of the head of the pancreas', 'interventionNames': ['Device: robotic resection with Da Vinci Xi']}, {'label': 'Distal pancreatectomy', 'description': 'Resection of the body and the tail of the pancreas', 'interventionNames': ['Device: robotic resection with Da Vinci Xi']}, {'label': 'Total pancreatectomy', 'description': 'Total removal of the pancreas', 'interventionNames': ['Device: robotic resection with Da Vinci Xi']}, {'label': 'central pancreatectomy', 'description': 'body or neck of the pancreas resection', 'interventionNames': ['Device: robotic resection with Da Vinci Xi']}], 'interventions': [{'name': 'robotic resection with Da Vinci Xi', 'type': 'DEVICE', 'description': 'robotic resection with Da Vinci Xi', 'armGroupLabels': ['Distal pancreatectomy', 'Duoneopancreatectomy', 'Total pancreatectomy', 'central pancreatectomy']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to local law with personal data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General Universitario de Alicante', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Candido Fernando Alcazar-Lopez', 'investigatorAffiliation': 'Hospital General Universitario de Alicante'}}}}