Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2026-01-08 @ 5:25 AM
Study NCT ID:
NCT03203434
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2017-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Detection of Anastomotic Leakage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057868', 'term': 'Anastomotic Leak'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-28', 'studyFirstSubmitDate': '2017-06-27', 'studyFirstSubmitQcDate': '2017-06-27', 'lastUpdatePostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anastomotic leakage', 'timeFrame': 'Postoperatively (30-days)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic cancer', 'Esophageal cancer', 'volatile organic compounds', 'Field asymmetric ion mobility spectrometry'], 'conditions': ['Anastomotic Leak']}, 'descriptionModule': {'briefSummary': 'Esophagectomy or pancreaticoduodenectomy is the standard surgical approach for patients with malignant tumors of the esophagus or pancreatic head. These procedures are associated with high morbidity rates, which are strongly correlated with the occurrence of anastomotic leakage. Current diagnostic methods, including clinical, biochemical and radiological techniques are frequently inconclusive. Delay in diagnosis leads to delay in treatment, which ratifies the need for development of novel and accurate non-invasive diagnostic tests for detection of anastomotic leakage. Urinary volatile organic compounds reflect the metabolic status of an individual, which is associated with a systemic immunological response. The aim of this study was to determine the diagnostic accuracy of urinary volatile organic compounds to detect anastomotic leakage after esophagectomy or pancreaticoduodenectomy in an early phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible participants had suspected malignancies of the esophagus, pancreas, distal bile duct, ampulla Vateri or duodenum and were scheduled for surgery (i.e. esophagectomy or pancreaticoduodenectomy).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients were aged 18-90 years\n* American Society of Anesthesiologists (ASA) physical status of 3 or lower\n* All participants were capable to understand the study information and signed written informed consent\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03203434', 'briefTitle': 'Non-invasive Detection of Anastomotic Leakage', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'Non-invasive Detection of Anastomotic Leakage Following Esophageal and Pancreatic Surgery by Urinary Analysis', 'orgStudyIdInfo': {'id': '2014.543'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Esophageal anastomotic leakage', 'interventionNames': ['Diagnostic Test: Urinary volatile organic compound analysis']}, {'label': 'Esophageal uncomplicated controls', 'interventionNames': ['Diagnostic Test: Urinary volatile organic compound analysis']}, {'label': 'Pancreatic anastomotic leakage', 'interventionNames': ['Diagnostic Test: Urinary volatile organic compound analysis']}, {'label': 'Pancreatic uncomplicated controls', 'interventionNames': ['Diagnostic Test: Urinary volatile organic compound analysis']}], 'interventions': [{'name': 'Urinary volatile organic compound analysis', 'type': 'DIAGNOSTIC_TEST', 'armGroupLabels': ['Esophageal anastomotic leakage', 'Esophageal uncomplicated controls', 'Pancreatic anastomotic leakage', 'Pancreatic uncomplicated controls']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Freek Daams, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amsterdam UMC, location VUmc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Victor Plat', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}