Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-03-05 @ 7:52 PM
Study NCT ID:
NCT01980394
Status:
COMPLETED
Last Update Posted:
2016-02-25
First Post:
2013-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Esophageal Stump Washout
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-24', 'studyFirstSubmitDate': '2013-08-30', 'studyFirstSubmitQcDate': '2013-11-04', 'lastUpdatePostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of intraluminal tumor cells in the remaining oesophageal stump', 'timeFrame': 'during the operation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['esophagus', 'gastro-esophegeal junction', 'cancer', 'tumor seeding', 'free viable tumor cells', 'surgery', 'intraluminal tumor cells', 'stump washout'], 'conditions': ['Esophageal Cancer', 'Gastrooesophageal Cancer']}, 'descriptionModule': {'briefSummary': 'Intraluminally shed viable tumor cells might contribute to local recurrence in cancer of the esophagus and the cardia. The aim of the the study was to establish a method of mechanical lavage of the remaining part of the esophagus and, hence, to reduce the intraluminal cancer cells before doing the esophageal anastomosis.', 'detailedDescription': 'See study protocol!'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically confirmed cancer of gastro-esophageal junction with indication for surgery\n\nExclusion Criteria:\n\n* missing informed consent'}, 'identificationModule': {'nctId': 'NCT01980394', 'briefTitle': 'Esophageal Stump Washout', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Liestal'}, 'officialTitle': 'Esophageal Stump Washout Reduces Free Intraluminal Tumor Cells During Resection of Carcinomas of the Esophagus and Cardia', 'orgStudyIdInfo': {'id': 'Liestal-2012-OES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'prospective cohort study', 'interventionNames': ['Procedure: Esophageal Stump Washout']}], 'interventions': [{'name': 'Esophageal Stump Washout', 'type': 'PROCEDURE', 'description': 'a washout of the closed esophageal stump with Ringer-solution (10 times 30ml) is performed by means of a transorally inserted 24F-Foley catheter. The first, fifth and tenth portion of the lavage fluid are collected and sent to cytological examination', 'armGroupLabels': ['prospective cohort study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4410', 'city': 'Liestal', 'state': 'Basel-Landschaft', 'country': 'Switzerland', 'facility': 'Kantonsspital Baselland, Liestal', 'geoPoint': {'lat': 47.48455, 'lon': 7.73446}}], 'overallOfficials': [{'name': 'Christoph A. Maurer, Professor, Chairman of Surgery', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital of Liestal, Liestal, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Liestal', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bern', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}