Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04522193

Dumping Syndrome and Esophageal Atresia

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Oesophageal Atresia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deglutition Disorders Digestive System Abnormalities Digestive System Diseases Dumping Syndrome Esophageal Atresia Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postgastrectomy Syndromes Postoperative Complications Stomach Diseases

Age range

2 month–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Jeanne de Flandre - Pôle enfant, CHU de Lille, Lille, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glycemic Holter

Device

Continuous glycaemia monitoring,

gastric emptying scintigraphy

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

Device

continuous cardiac monitoring

Primary outcomes

  1. Abnormal glycaemia associated with vagal hypertonia

    Time frame: At least once during the 48 hours monitoring

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

Secondary outcomes

  1. Abnormal glycaemia associated with abnormal gastric emptying

    Time frame: At least once during the 48 hours monitoring

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

  2. Persistance of dumping syndrome

    Time frame: At the age of 6 months

    measured by a gastric emptying scintigraphy

  3. Tolerance of glucose monitoring

    Time frame: At least once during the 48 hours monitoring

    Occurrence of side effects or technical issues during monitoring

Study contacts

Contact information is provided by the study sponsor or research team.

Madelaine AUMAR, MD

CONTACT

[email protected]

0320445962

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Groupement Interrégional de Recherche Clinique et d'Innovation
  • french patient association for oesophageal atresia AFAO

Registry information

Official study title

Physiopathology of Dumping Syndrome in Esophageal Atresia

Acronym: DUMTORING

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2020
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.