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Dumping Syndrome and Esophageal Atresia

Physiopathology of Dumping Syndrome in Esophageal Atresia

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04522193
Acronym
DUMTORING
Enrollment
15
Registered
2020-08-21
Start date
2024-02-23
Completion date
2026-11-30
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oesophageal Atresia, Dumping Syndrome

Keywords

Oesophageal dysmotility, Oesophageal atresia, Post prandial hypoglycaemia, Gastric emptying troubles

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

Interventions

DEVICEGlycemic Holter

Continuous glycaemia monitoring,

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

continuous cardiac monitoring

Sponsors

Groupement Interrégional de Recherche Clinique et d'Innovation
CollaboratorOTHER
french patient association for oesophageal atresia AFAO
CollaboratorUNKNOWN
University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Months to 3 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Abnormal glycaemia associated with vagal hypertoniaAt least once during the 48 hours monitoringComposite criteria: association between abnormal glycaemia (high or low) and variations of cardiac frequency

Secondary

MeasureTime frameDescription
Abnormal glycaemia associated with abnormal gastric emptyingAt least once during the 48 hours monitoringComposite criteria: association between abnormal glycaemia (high or low) and abnormal gastric emptying study
Persistance of dumping syndromeAt the age of 6 monthsmeasured by a gastric emptying scintigraphy
Tolerance of glucose monitoringAt least once during the 48 hours monitoringOccurrence of side effects or technical issues during monitoring

Countries

France

Contacts

Primary ContactMadelaine AUMAR, MD
madeleine.aumar@chru-lille.fr0320445962

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026