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RecruitingNCT04522193DUMTORINGUpdated Dec 23, 2025

Dumping Syndrome and Esophageal Atresia

An interventional study of Glycemic Holter and gastric emptying scintigraphy in Oesophageal Atresia and Dumping Syndrome, sponsored by University Hospital, Lille. Recruiting at 2 sites in France. Open to participants aged 2 Months to 3 Months. Per ClinicalTrials.gov, last updated 2025-12-23.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
2 Months to 3 Months
Sex
All
01

Study 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

02

Conditions studied

  • Oesophageal Atresia
  • Dumping Syndrome

Keywords

  • Oesophageal dysmotility
  • Oesophageal atresia
  • Post prandial hypoglycaemia
  • Gastric emptying troubles
03

Who can participate

Ages eligible
2 Months to 3 Months
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • 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 · Radiation: gastric emptying scintigraphy · Device: Holter ECG

Interventions

  • DeviceGlycemic Holter

    Continuous glycaemia monitoring,

  • Radiationgastric 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.

  • DeviceHolter ECG

    continuous cardiac monitoring

05

What researchers measure

Primary outcomes

  1. Abnormal glycaemia associated with vagal hypertonia

    Composite criteria: association between abnormal glycaemia (high or low) and variations of cardiac frequency

    Time frame: At least once during the 48 hours monitoring

Secondary outcomes

  1. Abnormal glycaemia associated with abnormal gastric emptying

    Composite criteria: association between abnormal glycaemia (high or low) and abnormal gastric emptying study

    Time frame: At least once during the 48 hours monitoring

  2. Persistance of dumping syndrome

    measured by a gastric emptying scintigraphy

    Time frame: At the age of 6 months

  3. Tolerance of glucose monitoring

    Occurrence of side effects or technical issues during monitoring

    Time frame: At least once during the 48 hours monitoring

06

Study locations

1 of 2 sites recruiting
  • Hôpital Jeanne de Flandres
    Lille, 59037, France
    • · Contact · 0320445962
    • Madelaine AUMAR, MD · Principal investigator
    Not yet recruiting
  • Hôpital Jeanne de Flandre - Pôle enfant, CHU de Lille
    Lille, France
    • Madeleine AUMAR · Contact
    Recruiting
07

Registry details

Key details

Study ID
NCT04522193
Lead sponsor
University Hospital, Lille
Collaborators
Groupement Interrégional de Recherche Clinique et d'Innovation, french patient association for oesophageal atresia AFAO
Responsible party
Sponsor
First posted
Aug 21, 2020
Start date
Feb 23, 2024
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Dec 23, 2025

Study contacts

Madelaine AUMAR, MD
Contact
madeleine.aumar@chru-lille.fr
0320445962
Madelaine AUMAR, MD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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