Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-02-20 @ 10:09 PM
Study NCT ID:
NCT02166957
Status:
COMPLETED
Last Update Posted:
2015-11-25
First Post:
2014-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effectiveness of Endoscopic "Rendez-vous" Technique Foresophageal Reconstructions for the Treatment of a Total and Extensive Disruption of the Esophagus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000402', 'term': 'Airway Obstruction'}, {'id': 'D004108', 'term': 'Dilatation, Pathologic'}], 'ancestors': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-23', 'studyFirstSubmitDate': '2014-06-12', 'studyFirstSubmitQcDate': '2014-06-17', 'lastUpdatePostDateStruct': {'date': '2015-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of the rendez vous approach for treating esophageal disruption', 'timeFrame': '2 days', 'description': 'We evaluate the technical and the clinical success. The technical success is the ability to recanalize the esophagus endoscopically.\n\nThe clnical success is the possibility to feed patients.'}], 'secondaryOutcomes': [{'measure': 'Number of endoscopic sessions', 'timeFrame': 'Up to 2 years'}, {'measure': 'Time before refeeding', 'timeFrame': '15 days'}, {'measure': 'Complications', 'timeFrame': '7 days', 'description': 'Per-operative complications (bleeding, perforations, anesthesiological) and post-operative (infection, bleeding...)'}, {'measure': 'Number of endoscopic dilation sessions after recanalization', 'timeFrame': 'Up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Esophageal disruption', 'anterograde-retrograde endoscopy', 'rendez-vous technique', 'NOTES', 'recanalization', 'dilatations', 'Stenting', 'radiation therapy', 'head and neck carcinoma'], 'conditions': ['Esophageal Disruption', 'Esophageal Obstruction']}, 'descriptionModule': {'briefSummary': 'Complete esophageal obstructions leads to definitive fasting. The rendez-vous endoscopic approach had already been described for complex stenoses but never for disruption with loss of tissue and SES. Patients and methods: This is a retrospective observationnal study about patients referred for complete esophageal disruption and classified in two groups: 1/ Long disruption (\\> 5cm), after caustic ingestion or due to an esophageal stripping during SEMS removal; 2/ Short disruption (\\< 5cm), consecutive to radiation therapy. All the procedures are performed according the anterograde retrograde approach, using CO2 and under X-rays guidance. We report the characteristeristics of the procedures, the efficacy, the time before discharge and refeeding, the complications, and the follow-up, especially the number of dilatation sessions for each group. The hypothesis is that anterograde retrograde endoscopic technique is safe and effective for the management of esophageal disruptions in patients for which the surgical treatment confers a high risk of morbidity and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a retrospective report about six patients referred for complete esophageal disruption', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Esophageal disruption with or without loss of SES\n\nExclusion Criteria:\n\n* Esophageal Complex stenosis\n* Mediastinitis\n* Severe sepsis\n* Coagulation abnormalities\n* Contra-indications to general anesthesia'}, 'identificationModule': {'nctId': 'NCT02166957', 'briefTitle': 'Evaluation of the Effectiveness of Endoscopic "Rendez-vous" Technique Foresophageal Reconstructions for the Treatment of a Total and Extensive Disruption of the Esophagus', 'organization': {'class': 'OTHER', 'fullName': "Société Française d'Endoscopie Digestive"}, 'officialTitle': 'Evaluation of the Effectiveness of Endoscopic "Rendez-vous" Technique for Esophageal Reconstructions for the Treatment of a Total and Extensive Disruption of the Esophagus', 'orgStudyIdInfo': {'id': 'OESORDV'}, 'secondaryIdInfos': [{'id': 'OESORECO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Long disruption > 5cm +/- loss of SES', 'interventionNames': ['Procedure: Recanalization']}, {'label': 'Short disruption < 5cm', 'interventionNames': ['Procedure: Recanalization']}], 'interventions': [{'name': 'Recanalization', 'type': 'PROCEDURE', 'description': 'All patients received clear and detailed information about the different steps, the benefits and the risks of the procedure they would undergo, and gave an informed consent.\n\nThe rendez-vous technique shared some common characteristics whatever the etiology and the length of esophageal disruption. First, prior to start the specific endoscopic management, all the patients needed to have undergone a surgical gastrostomy one month earlier in order to allow the retrograde access. This one-month delay was necessary to get it completely healed before using it for the procedure.\n\nThe principle of the combined anterograde retrograde approach is to get an endoscopic access to both the proximal and distal side of the obstruction in the purpose to achieve better and safer recanalization, which could be carried out with either transillumination or using a needle under x-rays guidance.', 'armGroupLabels': ['Long disruption > 5cm +/- loss of SES', 'Short disruption < 5cm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13915', 'city': 'Marseille', 'country': 'France', 'facility': 'APHM, North Hospital, Department of gastroenterology', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Société Française d'Endoscopie Digestive", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'VANBIERVLIET', 'investigatorAffiliation': "Société Française d'Endoscopie Digestive"}}}}