Dumping Syndrome and Esophageal Atresia

Dumping Syndrome Clinical Trial

— DUMTORING  

Official title:

Physiopathology of Dumping Syndrome in Esophageal Atresia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04522193
• Other study ID #: 2019_51
• Secondary ID: 2020-A01938-31
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2021
• Est. completion date: November 2023

Study information

• Verified date: April 2021
• Source: University Hospital, Lille
• Contact: Madelaine AUMAR, MD
• Phone: 0320445962
• Email: madeleine.aumar[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Dumping Syndrome
• Esophageal Atresia
• Oesophageal Atresia
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Jeanne de Flandres	Lille

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	french patient association for oesophageal atresia AFAO, Groupement Interrégional de Recherche Clinique et d'Innovation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Abnormal glycaemia associated with abnormal gastric emptying	Composite criteria: association between abnormal glycaemia (high or low) and abnormal gastric emptying study	At least once during the 48 hours monitoring
Secondary	Persistance of dumping syndrome	measured by a gastric emptying scintigraphy	At the age of 6 months
Secondary	Tolerance of glucose monitoring	Occurrence of side effects or technical issues during monitoring	At least once during the 48 hours monitoring