Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2026-03-03 @ 7:39 PM
Study NCT ID:
NCT02105506
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2014-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-23', 'studyFirstSubmitDate': '2014-04-02', 'studyFirstSubmitQcDate': '2014-04-04', 'lastUpdatePostDateStruct': {'date': '2015-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility', 'timeFrame': 'Surgical procedure', 'description': 'The adherence of the Tachosil patch'}], 'secondaryOutcomes': [{'measure': 'all cause mortality', 'timeFrame': 'within the first 30 days (plus or minus 3 days) after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Esophagus', 'Stomach', 'Resection', 'Esophageal disease requiring surgery', 'Gastric disease requiring surgery'], 'conditions': ['Esophageal Disease', 'Gastric Disease']}, 'descriptionModule': {'briefSummary': 'Rationale: The construction of esophageal anastomoses is associated with considerable risk at postoperative anastomotic leakage. Application of TachoSil®, a tissue sealant with human fibrinogen and thrombin, can improve strength of the esophageal anastomosis and potentially prevent anastomotic leakage.\n\nObjective: Evaluation of feasibility and safety of TachoSil® application on esophageal anastomoses.\n\nStudy design: Non-randomized, non-blinded, single-center intervention study. Study population: Patients, 18-80 years old, undergoing an elective total gastrectomy with an esophago-jejunostomy or esophagectomy with a planned esophagogastric anastomosis will be enrolled. A total number of 15 patients will be included in the study.\n\nIntervention: Gastric or esophageal resection will be executed according to the common procedures used in the UMC Utrecht. After construction of the esophageal anastomosis, all enrolled participants will receive a TachoSil® patch, which will be applied on the esophageal anastomosis intra-operatively. Hence, TachoSil® is used as an add-on therapy. TachoSil® will be degraded enzymatically in a period of approximately 24 weeks after application.\n\nMain study parameters/endpoints: The primary endpoint is feasibility, which is assessed by evaluation of adherence of the patch. A time-action analysis of the application of the Tachosil patch will be performed.\n\nNature and extent of the burden associated with participation: The burden for the patient is minimal. The total surgical procedure will be prolonged with 10-15 minutes. Postoperative care and outpatient visits do not differ from regular protocol. TachoSil® is approved and registered for supportive treatment in surgery for improvement of haemostasis and to promote tissue sealing by the European Commission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing an elective total gastrectomy with an esophago-jejunostomy or esophagectomy with a planned esophagogastric anastomosis\n* Male and female gender\n* Ages 18-80\n* Signed informed consent\n* For females of childbearing potential:\n\n * Patient uses a reliable contraceptive method: contraceptive pill, intrauterine device, subdermal implantation, or transdermal patch\n * Patient has a negative serum or urine pregnancy test.\n\nExclusion Criteria:\n\n* Emergency resections of esophagus of stomach\n* Unsigned informed consent\n* History of hypersensitivity reactions to human fibrinogen, human thrombin, or collagen.\n* Patients having difficulty understanding Dutch and English\n* Mentally incapable patients\n* Pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT02105506', 'acronym': 'SAFE-T', 'briefTitle': 'Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses', 'orgStudyIdInfo': {'id': 'NL38212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tachosil patch', 'description': 'Tachosil patch (9.5 x 4.8 cm), containing human fibrinogen (5.5 mg/cm2) and human thrombin (2.0 IU/cm2), applied during surgery. Up to 7 patches per participant may be applied.', 'interventionNames': ['Drug: Tachosil patch']}], 'interventions': [{'name': 'Tachosil patch', 'type': 'DRUG', 'armGroupLabels': ['Tachosil patch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3584 CX', 'city': 'Utrecht', 'state': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'R. van Hillegersberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. R. van Hillegersberg, surgeon', 'investigatorFullName': 'R. van Hillegersberg', 'investigatorAffiliation': 'UMC Utrecht'}}}}