DUMTORING: Dumping Syndrome and Esophageal Atresia

Sponsor

University Hospital, Lille (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04522193

Collaborator

Groupement Interrégional de Recherche Clinique et d'Innovation (Other), french patient association for oesophageal atresia AFAO (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Oesophageal Atresia Dumping Syndrome	Device: Glycemic Holter Radiation: gastric emptying scintigraphy Device: Holter ECG	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Physiopathology of Dumping Syndrome in Esophageal Atresia

Anticipated Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Experimental group

All children born at the Lille University Hospital during the investigation period with esophageal atresia type III or IV

Device: Glycemic Holter

Continuous glycaemia monitoring,

Radiation: gastric emptying scintigraphy

Fasting administration of a Technecium-labelled milk bottle and quantification of the remaining radioactivity by a camera every 30 minutes for 4 hours.

Device: Holter ECG

continuous cardiac monitoring

Outcome Measures

Primary Outcome Measures

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

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
Tolerance of glucose monitoring [At least once during the 48 hours monitoring]
Occurrence of side effects or technical issues during monitoring

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 3 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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