Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT04522193
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2020-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dumping Syndrome and Esophageal Atresia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004933', 'term': 'Esophageal Atresia'}, {'id': 'D004377', 'term': 'Dumping Syndrome'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D011178', 'term': 'Postgastrectomy Syndromes'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015716', 'term': 'Electrocardiography, Ambulatory'}], 'ancestors': [{'id': 'D004562', 'term': 'Electrocardiography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D018670', 'term': 'Monitoring, Ambulatory'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2020-08-18', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abnormal glycaemia associated with vagal hypertonia', 'timeFrame': 'At least once during the 48 hours monitoring', 'description': 'Composite criteria: association between abnormal glycaemia (high or low) and variations of cardiac frequency'}], 'secondaryOutcomes': [{'measure': 'Abnormal glycaemia associated with abnormal gastric emptying', 'timeFrame': 'At least once during the 48 hours monitoring', 'description': 'Composite criteria: association between abnormal glycaemia (high or low) and abnormal gastric emptying study'}, {'measure': 'Persistance of dumping syndrome', 'timeFrame': 'At the age of 6 months', 'description': 'measured by a gastric emptying scintigraphy'}, {'measure': 'Tolerance of glucose monitoring', 'timeFrame': 'At least once during the 48 hours monitoring', 'description': 'Occurrence of side effects or technical issues during monitoring'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oesophageal dysmotility', 'Oesophageal atresia', 'Post prandial hypoglycaemia', 'Gastric emptying troubles'], 'conditions': ['Oesophageal Atresia', 'Dumping Syndrome']}, 'descriptionModule': {'briefSummary': 'Dumping syndrome (DS) is frequent in oesophageal atresia (29%). In causing hypoglycaemia, it can be dangerous for neonates. Mechanisms of DS are actually partialy understood. This is also an affection difficult to diagnose, because it only occurs after meals and can be inconstantly present. To date, their is only symptomatic treatment for DS. This study aims to understand its pathological mechanisms so as to better treat it and avoid its consequences. Oesophageal atresia patients enrolled in this study will benefit from a continuous glycemic monitoring, a continuous cardiac monitoring, and an a gastric emptying scintigraphy at the age of 3 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients operated at birth for Oesophageal atresia type C\n* Aged from 2 to 3 months at inclusion\n* Off prokinetic treatment (suspended for at least 72 hours) before monitoring\n\nExclusion Criteria:\n\n* History of dumping syndrome of other cause (microgastria, fundoplication, dysautonomia..)\n* History of any disease that can modify glycemic regulation (hyperinsulinism, neonatal diabete)\n* Treatment that can modify gastric motility'}, 'identificationModule': {'nctId': 'NCT04522193', 'acronym': 'DUMTORING', 'briefTitle': 'Dumping Syndrome and Esophageal Atresia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Physiopathology of Dumping Syndrome in Esophageal Atresia', 'orgStudyIdInfo': {'id': '2019_51'}, 'secondaryIdInfos': [{'id': '2020-A01938-31', 'type': 'OTHER', 'domain': 'ID-RCB number,ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'All children born at the Lille University Hospital during the investigation period with esophageal atresia type III or IV', 'interventionNames': ['Device: Glycemic Holter', 'Radiation: gastric emptying scintigraphy', 'Device: Holter ECG']}], 'interventions': [{'name': 'Glycemic Holter', 'type': 'DEVICE', 'description': 'Continuous glycaemia monitoring,', 'armGroupLabels': ['Experimental group']}, {'name': 'gastric emptying scintigraphy', 'type': 'RADIATION', 'description': 'Fasting administration of a Technecium-labelled milk bottle and quantification of the remaining radioactivity by a camera every 30 minutes for 4 hours.', 'armGroupLabels': ['Experimental group']}, {'name': 'Holter ECG', 'type': 'DEVICE', 'description': 'continuous cardiac monitoring', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'role': 'CONTACT', 'phone': '0320445962'}, {'name': 'Madelaine AUMAR, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Jeanne de Flandres', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Madeleine AUMAR', 'role': 'CONTACT'}], 'facility': 'Hôpital Jeanne de Flandre - Pôle enfant, CHU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Madelaine AUMAR, MD', 'role': 'CONTACT', 'email': 'madeleine.aumar@chru-lille.fr', 'phone': '0320445962'}], 'overallOfficials': [{'name': 'Madelaine AUMAR, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': "Groupement Interrégional de Recherche Clinique et d'Innovation", 'class': 'OTHER'}, {'name': 'french patient association for oesophageal atresia AFAO', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}