Dumping Syndrome and Esophageal Atresia

Study Overview
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Brief Summary
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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

Official Title
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Physiopathology of Dumping Syndrome in Esophageal Atresia

Conditions
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Oesophageal Atresia, Dumping Syndrome

Intervention / Treatment
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* Device: Glycemic Holter
* Radiation: gastric emptying scintigraphy
* Device: Holter ECG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients operated at birth for Oesophageal atresia type C Aged from 2 to 3 months at inclusion Off prokinetic treatment (suspended for at least 72 hours) before monitoring Exclusion Criteria: History of dumping syndrome of other cause (microgastria, fundoplication, dysautonomia..) History of any disease that can modify glycemic regulation (hyperinsulinism, neonatal diabete) Treatment that can modify gastric motility

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>All children born at the Lille University Hospital during the investigation period with esophageal atresia type III or IV | Device: Glycemic Holter<br>* Continuous glycaemia monitoring,<br>Radiation: gastric emptying scintigraphy<br>* Fasting administration of a Technecium-labelled milk bottle and quantification of the remaining radioactivity by a camera every 30 minutes for 4 hours.<br>Device: Holter ECG<br>* continuous cardiac monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormal glycaemia associated with vagal hypertonia | Composite criteria: association between abnormal glycaemia (high or low) and variations of cardiac frequency | At least once during the 48 hours monitoring | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormal glycaemia associated with abnormal gastric emptying | Composite criteria: association between abnormal glycaemia (high or low) and abnormal gastric emptying study | At least once during the 48 hours monitoring | 
| Persistance of dumping syndrome | measured by a gastric emptying scintigraphy | At the age of 6 months | 
| Tolerance of glucose monitoring | Occurrence of side effects or technical issues during monitoring | At least once during the 48 hours monitoring | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oesophageal dysmotility, Oesophageal atresia, Post prandial hypoglycaemia, Gastric emptying troubles