Clinical trial NCT02525705: Dumping Syndrome After Operation of Esophageal Atresia Type III
Official title: Frequency of Occurrence of Dumping Syndrome After Operation of Esophageal Atresia Type III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oesophageal Atresia
Dumping Syndrome
Keywords: infants
oesophageal atresia
dumping syndrome
prevalence
Type III and IV
Oral glucose tolerance test
early hyperglycemia
late hypoglycemia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2015-08-17
Enrollment: 42
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* New born less than 3.5 months or age corrected for premature new born
* Weight ≥ 4, 150 kg
* Esophageal atresia (EA) type III or IV
* EA Surgery between May 2013 and June 2016
* Stop of prokinetic treatment \> 72 h before OGTT
* Information and consent of parents
* Patients with health insurance

Exclusion Criteria:

* Age \> 3.5 months
* Weight \< 4.150 kg
* Other types of EA
* Dumping syndrom from other origin: microgastria, dysautonomia, small intestine surgery
* Other pathology that can modify glycemia: neonatal diabete, hyperinsulinism
* Treatment that can modify gastric motility: domperidone, erythromycin, baclofen that hasn't been stopped in the 72h before OGTT
* Absence of consent
* Patient judiciary protected
* Simultaneous participation to another clinical trial
* No health insurance

Primary outcomes:
measure: Early hyperglycemia during Oral Glucose Tolerance Test (OGTT)
timeFrame: up to 240 min
measure: Late hypoglycemia during OGTT
timeFrame: up to 240 min
Secondary outcomes:
measure: Clinical signs presenting consequently to OGTT
timeFrame: continuous monitoring during 240 minutes
measure: Associated pathologies
timeFrame: 1 day
measure: Surgery details
timeFrame: 1 day
measure: Post-surgery complications
timeFrame: 1 day
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Pellegrin - Hôpital d'Enfants,
city: Grenoble
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: Hôpital Jeanne de Flandre CHRU
city: Lyon
country: France
facility: Hôpital Edouard Herriot,Unité d'Hépatogastroentérologie et Nutrition Pédiatriques
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: AP-HP, Hôpital Necker
city: Paris
country: France
facility: Hôpital Robert Debré ,Service de chirurgie viscérale et urologique
city: Rouen
country: France
facility: CHU Rouen
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse, Hôpital Enfant
Study officials:
affiliation: University Hospital, Lille
name: Laurent Michaud, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.