Menu
Recruiting NCT04522193

Dumping Syndrome and Esophageal Atresia

No phase Interventional Oesophageal Atresia Dumping Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Glycemic Holter, gastric emptying scintigraphy, Holter ECG.
Who it may be relevant to
Registry conditions: Oesophageal Atresia, Dumping Syndrome. Basic parameters: 2 months — 3 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Physiopathology of Dumping Syndrome in Esophageal Atresia

Overview

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

  • 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

Primary outcome measures

  • Abnormal glycaemia associated with vagal hypertonia [Time frame: At least once during the 48 hours monitoring]
Secondary outcome measures (3)
  • Abnormal glycaemia associated with abnormal gastric emptying [Time frame: At least once during the 48 hours monitoring]
  • Persistance of dumping syndrome [Time frame: At the age of 6 months]
  • Tolerance of glucose monitoring [Time frame: At least once during the 48 hours monitoring]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 2 centers
  • Hôpital Jeanne de Flandres — Lille
  • Hôpital Jeanne de Flandre - Pôle enfant, CHU de Lille — Lille

Identifiers

NCT: NCT04522193 · 2019_51 · 2020-A01938-31

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗