Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-01-03 @ 8:39 PM
Study NCT ID:
NCT02756468
Status:
UNKNOWN
Last Update Posted:
2016-04-29
First Post:
2016-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Procalcitonin Reveals Early Dehiscence in Pancreatic Surgery: the PREDIPS Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-28', 'studyFirstSubmitDate': '2016-04-18', 'studyFirstSubmitQcDate': '2016-04-28', 'lastUpdatePostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of PCT and CRP for anastomotic leak (AL) after pancreatic surgery', 'timeFrame': '2 yrs', 'description': 'Sensitivity: % of patients corrected identified by the biomarkers having AL; PCT: procalcitonin, CRP: C-reactive protein, AL: anastomic leak'}, {'measure': 'Specificity of PCT and CRP for anastomotic leak (AL) after pancreatic surgery', 'timeFrame': '2 yrs', 'description': 'Specificity: % of pts corrected identified by the biomarkers not having AL; PCT: procalcitonin, CRP: C-reactive protein, AL: anastomic leak'}], 'secondaryOutcomes': [{'measure': 'PCT and CRP cuts-off in 3rd POD with a good NPV for AL', 'timeFrame': '2 yrs', 'description': 'PCT: procalcitonin, CRP: C-reactive protein, NPV: negative predictive value'}, {'measure': 'PCT and CRP cuts-off in 5th POD with a good NPV for AL', 'timeFrame': '2 yrs', 'description': 'PCT: procalcitonin, CRP: C-reactive protein, NPV: negative predictive value'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pancreatic cancer', 'procalcitonin'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'Background. Pancreatic cancer surgery is associated with very high risk of postoperative morbidity and mortality. Anastomotic leak (AL) is one of the worst complications associated with relevant short and long-term sequelae. Procalcitonin (PCT) is a biomarker used to monitor bacterial infections and guide antibiotic therapy and has been shown to have better predictive value of AL after colorectal surgery than C-reactive protein (CRP) and white blood cell count (WBC).\n\nPurpose. The investigators designed a monocentric pilot study to test if PCT might be a sensitive and reliable marker of AL after pancreatic surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all pts undergoing pacreatic resections for cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing all different kinds of pancreatic surgery\n* in elective setting\n* for cancer\n* with a pancreatic anastomosis performed.\n\nExclusion Criteria:\n\n* age \\< 18 years\n* pregnant women\n* patients undergoing pancreatic surgery for benign disease, other kinds of pancreatic surgery without an anastomosis being performed'}, 'identificationModule': {'nctId': 'NCT02756468', 'acronym': 'PREDIPS', 'briefTitle': 'Procalcitonin Reveals Early Dehiscence in Pancreatic Surgery: the PREDIPS Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Procalcitonin Reveals Early Dehiscence in Pancreatic Surgery: the PREDIPS Study', 'orgStudyIdInfo': {'id': 'PREDIPS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pts operated for pancreatic cancer', 'description': 'all pts operated of pancreatic resection for cancer in the involved units', 'interventionNames': ['Other: pts operated for pancreatic cancer']}], 'interventions': [{'name': 'pts operated for pancreatic cancer', 'type': 'OTHER', 'description': 'measuring CRP and PCT in 3rd and 5th POD after pancreatic cancer resection', 'armGroupLabels': ['pts operated for pancreatic cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00189', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Valentina Giaccaglia, MD', 'role': 'CONTACT', 'email': 'v.giaccaglia@gmail.com', 'phone': '00393397882429'}, {'name': 'Valentina Giaccaglia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Sant'Andrea University Hospital", 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Valentina Giaccaglia, MD', 'role': 'CONTACT', 'email': 'v.giaccaglia@gmail.com', 'phone': '+393397882429'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Valentina Giaccaglia', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}