Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-03-03 @ 5:44 AM
Study NCT ID:
NCT02525705
Status:
COMPLETED
Last Update Posted:
2019-08-05
First Post:
2015-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dumping Syndrome After Operation of Esophageal Atresia Type III
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': 'D006943', 'term': 'Hyperglycemia'}], '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': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-01', 'studyFirstSubmitDate': '2015-08-14', 'studyFirstSubmitQcDate': '2015-08-14', 'lastUpdatePostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early hyperglycemia during Oral Glucose Tolerance Test (OGTT)', 'timeFrame': 'up to 240 min', 'description': 'Hypoglycemia : glycemia \\< 0,6 g/L'}, {'measure': 'Late hypoglycemia during OGTT', 'timeFrame': 'up to 240 min', 'description': 'Hyperglycemia : \\> 1,8g/L from H0 to 30 min after oral intake, \\> 1.7 between 1 and 2 h ours, \\> 1.4 between 2 and 3 h\n\n, \\> 1, 26 after 3 h'}], 'secondaryOutcomes': [{'measure': 'Clinical signs presenting consequently to OGTT', 'timeFrame': 'continuous monitoring during 240 minutes', 'description': 'frequent clinical reflux (\\>3/day), suspicion of esophagitis (pain while eating), colics, post-prandial diarrhea (liquid stools in the first hour after meal), abdominal pain, flatulence, pallor, hypotonia, agitation, convulsions, somnolence, sweat'}, {'measure': 'Associated pathologies', 'timeFrame': '1 day', 'description': 'neurologic, extremities, ribbs and vertebrales, genito-urinary, renal, cardiovascular, ano-rectal, microgastria and others. Syndromic associations are also noted, as VACTERL and charge syndroms.'}, {'measure': 'Surgery details', 'timeFrame': '1 day', 'description': 'postponed anastomosis, difficulty or tension in the suture, colic or gastric plasty if needed, tracheoscopy realisation, visualisation or damage of the X nerve, observation of a microgastria during surgery, other relevant informations of surgery'}, {'measure': 'Post-surgery complications', 'timeFrame': '1 day', 'description': 'anastomotic leakage, mediastinitis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infants', 'oesophageal atresia', 'dumping syndrome', 'prevalence', 'Type III and IV', 'Oral glucose tolerance test', 'early hyperglycemia', 'late hypoglycemia'], 'conditions': ['Oesophageal Atresia', 'Dumping Syndrome']}, 'referencesModule': {'references': [{'pmid': '11527163', 'type': 'RESULT', 'citation': 'Bufler P, Ehringhaus C, Koletzko S. Dumping syndrome: a common problem following Nissen fundoplication in young children. Pediatr Surg Int. 2001 Jul;17(5-6):351-5. doi: 10.1007/s003830000525.'}, {'pmid': '8890072', 'type': 'RESULT', 'citation': 'Samuk I, Afriat R, Horne T, Bistritzer T, Barr J, Vinograd I. Dumping syndrome following Nissen fundoplication, diagnosis, and treatment. J Pediatr Gastroenterol Nutr. 1996 Oct;23(3):235-40. doi: 10.1097/00005176-199610000-00006.'}, {'pmid': '12948306', 'type': 'RESULT', 'citation': 'Zung A, Zadik Z. Acarbose treatment of infant dumping syndrome: extensive study of glucose dynamics and long-term follow-up. J Pediatr Endocrinol Metab. 2003 Jul-Aug;16(6):907-15. doi: 10.1515/jpem.2003.16.6.907.'}, {'pmid': '11743518', 'type': 'RESULT', 'citation': 'Ng DD, Ferry RJ Jr, Kelly A, Weinzimer SA, Stanley CA, Katz LE. Acarbose treatment of postprandial hypoglycemia in children after Nissen fundoplication. J Pediatr. 2001 Dec;139(6):877-9. doi: 10.1067/mpd.2001.119169.'}, {'pmid': '20385264', 'type': 'RESULT', 'citation': 'Michaud L, Sfeir R, Couttenier F, Turck D, Gottrand F. Dumping syndrome after esophageal atresia repair without antireflux surgery. J Pediatr Surg. 2010 Apr;45(4):E13-5. doi: 10.1016/j.jpedsurg.2010.01.016.'}, {'pmid': '17638154', 'type': 'RESULT', 'citation': 'Holschneider P, Dubbers M, Engelskirchen R, Trompelt J, Holschneider AM. Results of the operative treatment of gastroesophageal reflux in childhood with particular focus on patients with esophageal atresia. Eur J Pediatr Surg. 2007 Jun;17(3):163-75. doi: 10.1055/s-2007-965087.'}, {'pmid': '32443041', 'type': 'DERIVED', 'citation': 'Aumar M, Gottrand F, Chalouhi C, Blanc S, Thomassin N, Piloquet H, Gastineau S, Schneider A, Krishnan U, Duvoisin G, Turck D, Coopman S, Michaud L. Frequency of Abnormal Glucose Tolerance Test Suggestive of Dumping Syndrome Following Oesophageal Atresia Repair. J Pediatr Gastroenterol Nutr. 2020 Jun;70(6):820-824. doi: 10.1097/MPG.0000000000002651.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the prevalence at 3.5 months of age of dumping syndrome in children operated at birth for oesophageal atresia type III et IV.', 'detailedDescription': 'Consecutive patients with type III and IV oesophageal atresia that are born in 8 different centers in France and Sydney (Australia) are included in the study, if willing. As soon as they weigh more than 4.150kg and if they are still younger than 3.5 months, an Oral Glucose Tolerance Test (OGTT) is performed. Glycemia and insulinemia are monitored every 30 minutes from intake to 240 minutes. Clinical signs that are presented are noted. If early hyperglycemia or late hypoglycemia are biologically or clinically observed, ascarbose treatment is initiated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* New born less than 3.5 months or age corrected for premature new born\n* Weight ≥ 4, 150 kg\n* Esophageal atresia (EA) type III or IV\n* EA Surgery between May 2013 and June 2016\n* Stop of prokinetic treatment \\> 72 h before OGTT\n* Information and consent of parents\n* Patients with health insurance\n\nExclusion Criteria:\n\n* Age \\> 3.5 months\n* Weight \\< 4.150 kg\n* Other types of EA\n* Dumping syndrom from other origin: microgastria, dysautonomia, small intestine surgery\n* Other pathology that can modify glycemia: neonatal diabete, hyperinsulinism\n* Treatment that can modify gastric motility: domperidone, erythromycin, baclofen that hasn't been stopped in the 72h before OGTT\n* Absence of consent\n* Patient judiciary protected\n* Simultaneous participation to another clinical trial\n* No health insurance"}, 'identificationModule': {'nctId': 'NCT02525705', 'acronym': 'DUMPING', 'briefTitle': 'Dumping Syndrome After Operation of Esophageal Atresia Type III', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Frequency of Occurrence of Dumping Syndrome After Operation of Esophageal Atresia Type III', 'orgStudyIdInfo': {'id': '2009_42/1004'}, 'secondaryIdInfos': [{'id': '2010-A00217-32', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Every EA patients', 'description': 'This is a one group interventional study. Every patient is included in the same arm.', 'interventionNames': ['Biological: Oral Glucose']}], 'interventions': [{'name': 'Oral Glucose', 'type': 'BIOLOGICAL', 'description': '1.75g/kg of glucose is orally taken by the patient. Capillary glycemia is systematically realised before ingestion (H0) and after 30, 60, 90, 120, 180 and 240 min and/or if clinical signs of hypoglycemia are presented by the patient.', 'armGroupLabels': ['Every EA patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': "Hôpital Pellegrin - Hôpital d'Enfants,", 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Jeanne de Flandre CHRU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'country': 'France', 'facility': "Hôpital Edouard Herriot,Unité d'Hépatogastroentérologie et Nutrition Pédiatriques", 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Nantes', 'country': 'France', 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'country': 'France', 'facility': 'AP-HP, Hôpital Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Robert Debré ,Service de chirurgie viscérale et urologique', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'CHU Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse, Hôpital Enfant', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Laurent Michaud, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}