Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-02 @ 2:39 AM
Study NCT ID:
NCT00686569
Status:
COMPLETED
Last Update Posted:
2014-08-05
First Post:
2008-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mediastinal Microdialysis in Patients With Oesophageal or Cardia Cancer Treated by Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057868', 'term': 'Anastomotic Leak'}, {'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': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-03', 'studyFirstSubmitDate': '2008-05-27', 'studyFirstSubmitQcDate': '2008-05-29', 'lastUpdatePostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early detection of postoperative complications', 'timeFrame': '30 days postoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anastomotic Leakage', 'Esophageal Cancer']}, 'referencesModule': {'references': [{'pmid': '24656920', 'type': 'RESULT', 'citation': 'Ellebaek M, Qvist N, Fristrup C, Mortensen MB. Mediastinal microdialysis in the diagnosis of early anastomotic leakage after resection for cancer of the esophagus and gastroesophageal junction. Am J Surg. 2014 Sep;208(3):397-405. doi: 10.1016/j.amjsurg.2013.09.026. Epub 2014 Jan 16.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative anastomotic leakage is a serious complication in patients with oesophageal or cardia cancer. Early diagnosis and treatment are mandatory. The primary aim of the present study is to investigate the clinical use of mediastinal microdialysis and whether is able to detect anastomotic leakage prior to the development of clinical symptoms.', 'detailedDescription': 'Patients undergoing oesophageal or cardia resection for cancer are monitored by mediastinal microdialysis during the postoperative period. Subcutaneous microdialysis serves as a control. Samples are collected every 4-hour. Samples will be analyzed continuously but the results will not be included in the clinical evaluation of the patient.\n\nA total of 30 patients will be included in this pilot study. The results of the mediastinal microdialyses will be compared with the clinical course in each patient. The results form the uncomplicated courses will be used to define the normal variations in mediastinal microdialysis. This will be compared to results from patients with various complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoin oesophageal resection for cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological verified oesophageal or cardia cancer\n\nExclusion Criteria:\n\n* Lack of consent, otherwise none'}, 'identificationModule': {'nctId': 'NCT00686569', 'briefTitle': 'Mediastinal Microdialysis in Patients With Oesophageal or Cardia Cancer Treated by Resection', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Mediastinal Microdialysis in Early Diagnosis of Anastomotic Leakage After Resection for Esophageal Cancer: Preliminary Results', 'orgStudyIdInfo': {'id': 'S-20070062'}}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Surgical department A, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': 'DK-5000', 'city': 'Odense C', 'country': 'Denmark', 'facility': 'Odense University Hospital, surgical department A', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}], 'overallOfficials': [{'name': 'Niels Qvist, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Niels Qvist', 'investigatorAffiliation': 'Odense University Hospital'}}}}