Dumping Syndrome and Esophageal Atresia
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