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Dumping Syndrome and Esophageal Atresia

NCT ID: NCT04522193

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-23

Study Completion Date

2026-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Oesophageal Atresia Dumping Syndrome

Keywords

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Oesophageal dysmotility Oesophageal atresia Post prandial hypoglycaemia Gastric emptying troubles

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental group

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

Group Type EXPERIMENTAL

Glycemic Holter

Intervention Type DEVICE

Continuous glycaemia monitoring,

gastric emptying scintigraphy

Intervention Type RADIATION

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

Holter ECG

Intervention Type DEVICE

continuous cardiac monitoring

Interventions

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Glycemic Holter

Continuous glycaemia monitoring,

Intervention Type DEVICE

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.

Intervention Type RADIATION

Holter ECG

continuous cardiac monitoring

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

2 Months

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupement Interrégional de Recherche Clinique et d'Innovation

OTHER

Sponsor Role collaborator

french patient association for oesophageal atresia AFAO

UNKNOWN

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Madelaine AUMAR, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Jeanne de Flandres

Lille, , France

Site Status NOT_YET_RECRUITING

Hôpital Jeanne de Flandre - Pôle enfant, CHU de Lille

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Madelaine AUMAR, MD

Role: CONTACT

Phone: 0320445962

Email: [email protected]

Facility Contacts

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Role: primary

Madeleine AUMAR

Role: primary

Other Identifiers

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2020-A01938-31

Identifier Type: OTHER

Identifier Source: secondary_id

2019_51

Identifier Type: -

Identifier Source: org_study_id