Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-01-01 @ 5:20 PM
Study NCT ID:
NCT03267966
Status:
COMPLETED
Last Update Posted:
2020-02-06
First Post:
2017-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Margin Status After Pancreaticoduodenectomy for Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-05', 'studyFirstSubmitDate': '2017-08-11', 'studyFirstSubmitQcDate': '2017-08-29', 'lastUpdatePostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'R1 resection rate', 'timeFrame': '1 month', 'description': 'To evaluate difference in terms of R1 resection rates between study groups with 0-mm and 1-mm clearance'}], 'secondaryOutcomes': [{'measure': 'pathological data', 'timeFrame': '1 month', 'description': 'To evaluate differences in pathological results (T status, N status, number of blocks, number of lymphnodes, etc) between the two study groups'}, {'measure': 'oncological results', 'timeFrame': '60 months', 'description': 'To evaluate the correlation between R1 resection and oncological results (local recurrence, overall survival) in the two study groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['periampullary cancer', 'margin status', 'R1 resection', 'clearance margin'], 'conditions': ['Pancreatic Cancer', 'Cholangiocarcinoma', 'Ampullary Cancer']}, 'descriptionModule': {'briefSummary': 'This multicentric prospective randomized controlled trial (RCT) compares the Leeds Pathology Protocol (LEEPP) with other "conventional" pathological protocol of PD specimen for periampullary cancer. Our aims were to evaluate the impact of the protocol and of the clearance on R1 rate and its prognostic value.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pancreaticoduodenectomy for periampullary cancer\n\nExclusion Criteria:\n\n* diagnosis of neuroendocrine neoplasm;\n* previous pancreatic surgery;\n* frozen section of each transection margins not performed or presence of positive transection margins without further resection (R1 intraoperative resection);\n* presence of macroscopic residual tumor (R2 resection).'}, 'identificationModule': {'nctId': 'NCT03267966', 'briefTitle': 'Margin Status After Pancreaticoduodenectomy for Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Campus Bio-Medico University'}, 'officialTitle': 'Margin Status After Pancreaticoduodenectomy for Cancer. Results of a Multicentric Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'NI 01/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Leeds Pathology Protocol (LEEPP)', 'interventionNames': ['Diagnostic Test: Leeds Pathology Protocol (LEEPP)']}, {'type': 'NO_INTERVENTION', 'label': 'Group B', 'description': '"Conventional" method of pathological evaluation'}], 'interventions': [{'name': 'Leeds Pathology Protocol (LEEPP)', 'type': 'DIAGNOSTIC_TEST', 'description': 'LEEPP includes: 1) multicolor inking; 2) axial slicing; 3) circumferential margin; 4) 1-mm clearance', 'armGroupLabels': ['Group A']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Campus Bio-Medico University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Humanitas Hospital, Italy', 'class': 'OTHER'}, {'name': 'Azienda Ospedaliero, Universitaria Pisana', 'class': 'OTHER'}, {'name': 'Medical University of Silesia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Gennaro Nappo', 'investigatorAffiliation': 'Campus Bio-Medico University'}}}}