Dumping Syndrome and Esophageal Atresia

Not Applicable

• Conditions: Dumping Syndrome; Oesophageal Atresia
• Interventions: Device: Glycemic Holter; Radiation: gastric emptying scintigraphy; Device: Holter ECG

• Registration Number: NCT04522193
• Lead Sponsor: University Hospital, Lille

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-18
• Study First Posted: 2020-08-21
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-23
• Study Start: 2021-11
• Primary Completion: 2023-11
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Glycemic Holter	All children born at the Lille University Hospital during the investigation period with esophageal atresia type III or IV
Experimental group	Holter ECG	All children born at the Lille University Hospital during the investigation period with esophageal atresia type III or IV
Experimental group	gastric emptying scintigraphy	All children born at the Lille University Hospital during the investigation period with esophageal atresia type III or IV

Primary Outcome Measures

Name	Time	Method
Abnormal glycaemia associated with vagal hypertonia	At least once during the 48 hours monitoring	Composite criteria: association between abnormal glycaemia (high or low) and variations of cardiac frequency

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Jeanne de Flandres; 🇫🇷 Lille, France