Dumping Syndrome and Esophageal Atresia

NCT04522193 | Recruiting

• 2 other identifiers: 2019_512020-A01938-31
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Oesophageal Atresia; Dumping Syndrome

Keywords

Oesophageal dysmotility; Oesophageal atresia; Post prandial hypoglycaemia; Gastric emptying troubles

Outcome Measures

Primary Outcomes (1)

• Abnormal glycaemia associated with vagal hypertonia

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

  At least once during the 48 hours monitoring

Secondary Outcomes (3)

• Abnormal glycaemia associated with abnormal gastric emptying

  At least once during the 48 hours monitoring

• Persistance of dumping syndrome

  At the age of 6 months

• Tolerance of glucose monitoring

  At least once during the 48 hours monitoring

Study Arms (1)

Experimental group

EXPERIMENTAL

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

Glycemic Holter DEVICE

Continuous glycaemia monitoring,

Experimental group

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.

Experimental group

Holter ECG DEVICE

continuous cardiac monitoring

Experimental group

Eligibility Criteria

• Age: 2 Months - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients operated at birth for Oesophageal atresia type C
• Off prokinetic treatment (suspended for at least 72 hours) before monitoring

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Groupement Interrégional de Recherche Clinique et d'Innovation: collaborator
• french patient association for oesophageal atresia AFAO: collaborator

Study Sites (2)

Hôpital Jeanne de Flandres

Lille, 59037, France

NOT YET RECRUITING

Hôpital Jeanne de Flandre - Pôle enfant, CHU de Lille

Lille, France

RECRUITING

MeSH Terms

Conditions

Esophageal Atresia; Dumping Syndrome; Esophageal Motility Disorders; Hypoglycemia

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Madelaine AUMAR, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madelaine AUMAR, MD

CONTACT

0320445962; madeleine.aumar@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 21, 2020
• Study Start: February 23, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (2)