Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-28 @ 9:49 PM
Study NCT ID:
NCT04728750
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2021-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Enucleation of Frantz's Tumor of the Pancreas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2021-01-21', 'studyFirstSubmitQcDate': '2021-01-25', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete enucleation of a tumor in the pancreas', 'timeFrame': 'December 2020', 'description': 'Performance of a laparoscopic enucleation of a tumor in the pancreas, and compared it with a conventional approach'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Pseudopapillary Neoplasm of the Pancreas']}, 'descriptionModule': {'briefSummary': 'The present study describes a 32-year-old female patient, in whom a preoperative imaging diagnosis confirmed a mass in the junction of the body and tail of the pancreas. Based on the anamnesis, on the preoperative diagnosis, and on the general status of the patient, the decision was made to performed laparoscopic enucleation of the pancreatic tumor. The operation and postoperative recovery passed without complications. A minimally invasive surgical approach should be applied whenever the dimensions and the localization of the tumor permits it, bearing in mind all the benefits and advantages that this surgical technique has to offer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosed pancreatic tumor by image study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with benign tumor of the pancreas\n* Patients with a size tumor of less than 3 cm on the pancreas\n\nExclusion Criteria:\n\n* Patients with a size tumor greater than 3 cm on the pancreas\n* Malignant tumors of the pancreas'}, 'identificationModule': {'nctId': 'NCT04728750', 'briefTitle': "Laparoscopic Enucleation of Frantz's Tumor of the Pancreas", 'organization': {'class': 'OTHER', 'fullName': 'Tecnologico de Monterrey'}, 'officialTitle': "Laparoscopic Enucleation of Frantz's Tumor of the Pancreas: Case Report and Literature Review", 'orgStudyIdInfo': {'id': 'FT7831'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Enucleation of a tumor of the pancreas', 'type': 'PROCEDURE', 'description': 'Enucleation of a tumor in the pancreas is feasible and safe, as it offers a minimally invasive approach, and morbidities are fewer than open or conventional approach'}]}, 'contactsLocationsModule': {'locations': [{'zip': '76140', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Escuela Nacional de Medicina, Tecnologico de Monterrey', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tecnologico de Monterrey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Alejandro Ruiz Velasco Santacruz', 'investigatorAffiliation': 'Tecnologico de Monterrey'}}}}