Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT04319835
Status:
COMPLETED
Last Update Posted:
2020-08-19
First Post:
2016-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D057868', 'term': 'Anastomotic Leak'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-17', 'studyFirstSubmitDate': '2016-03-30', 'studyFirstSubmitQcDate': '2020-03-20', 'lastUpdatePostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of lactate measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology', 'timeFrame': 'Measured with four hour intervals during the first seven postoperative days', 'description': 'Concentration in millimoles / liter of lactate measured repeatedly (see below) to produce a metabolic profile over time'}, {'measure': 'Concentration of lactate measured by microdialysis in patients with a normal uncomplicated postoperative recovery', 'timeFrame': 'Measured with four hour intervals during the first seven postoperative days', 'description': 'Concentration in millimoles / liter of lactate measured repeatedly (see below) to produce a metabolic profile over time'}, {'measure': 'Concentration of glucose measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology', 'timeFrame': 'Measured with four hour intervals during the first seven postoperative days', 'description': 'Concentration in millimoles / liter of glucose measured repeatedly (see below) to produce a metabolic profile over time'}, {'measure': 'Concentration of glucose measured by microdialysis in patients with a normal uncomplicated postoperative recovery', 'timeFrame': 'Measured with four hour intervals during the first seven postoperative days', 'description': 'Concentration in millimoles / liter of glucose measured repeatedly (see below) to produce a metabolic profile over time'}, {'measure': 'Concentration of pyruvate measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology', 'timeFrame': 'Measured with four hour intervals during the first seven postoperative days', 'description': 'Concentration in millimoles / liter of pyruvate measured repeatedly (see below) to produce a metabolic profile over time'}, {'measure': 'Concentration of pyruvate measured by microdialysis in patients with a normal uncomplicated postoperative recovery', 'timeFrame': 'Measured with four hour intervals during the first seven postoperative days', 'description': 'Concentration in millimoles / liter of pyruvate measured repeatedly (see below) to produce a metabolic profile over time'}, {'measure': 'Concentration of glycerol measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology', 'timeFrame': 'Measured with four hour intervals during the first seven postoperative days', 'description': 'Concentration in millimoles / liter of glycerol measured repeatedly (see below) to produce a metabolic profile over time'}, {'measure': 'Concentration of glycerol measured by microdialysis in patients with a normal uncomplicated postoperative recovery', 'timeFrame': 'Measured with four hour intervals during the first seven postoperative days', 'description': 'Concentration in millimoles / liter of glycerol measured repeatedly (see below) to produce a metabolic profile over time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Microdialysis', 'Ischemia', 'Anastomotic Leakage']}, 'descriptionModule': {'briefSummary': 'Postoperative surveillance of local metabolism of the surgical reconstruction after esophagectomy by means of Microdialysis. Dialysate is collected continuously for seven postoperative Days. Results analysed in a blinded fashion and related to the clinical outcome. Primary endpoint: anastomotic leakage', 'detailedDescription': "The purpose of the study is to evaluate Onzurf probe (microdialysis probe) as a monitoring method for the early diagnosis of complications after surgery in the gastrointestinal tract. Samples taken with Onzurf probe will be analyzed and then compared with routine clinical data on surgical procedures in gastrointesinala tract. These parameters are: Patient general condition, endoscopy, radiology and routine clinical samples (global) as CRP (C-reactive protein), white blood cells, blood gases.The patients are their own controls when the purpose is to see if you can detect early complications with Onzurf probe and also identify how many people gets complications after surgery in the gastrointestinal tract. The patients' clinical routine tests (blood tests, etc.) will serve as control samples, which then will be compared with results from sampling of Onzurf probe. No interventions will be carried out on the patient."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients accepted for esophagectomy with Gastric Tube reconstruction in the Department\n\nExclusion Criteria:\n\n* Surgical recontruction other than Gastric Tube'}, 'identificationModule': {'nctId': 'NCT04319835', 'briefTitle': 'Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy', 'orgStudyIdInfo': {'id': 'U-1506'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microdialysis catheter', 'description': 'Surface Microdialysis catheter will be placed onto the surgical reconstruction after esophagectomy and will be evaluated for clinical safety and performance. The metabolic profile as measured by Microdialysis will be correlated to the clinical outcome. No interventions based on the results will be performed.', 'interventionNames': ['Device: OnZurf Probe']}], 'interventions': [{'name': 'OnZurf Probe', 'type': 'DEVICE', 'armGroupLabels': ['Microdialysis catheter']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lund', 'state': 'Skåne County', 'country': 'Sweden', 'facility': 'Skånes Universitetssjukhuset', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Jan Johansson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Region Skane'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'collaborators': [{'name': 'Senzime AB', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}