Dumping Syndrome and Esophageal Atresia (DUMTORING)

Physiopathology of Dumping Syndrome in 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

Study Overview

• Status: Not yet recruiting
• Conditions: Dumping Syndrome; Oesophageal Atresia
• Intervention / Treatment: Device: Glycemic Holter; Radiation: gastric emptying scintigraphy; Device: Holter ECG

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madelaine AUMAR, MD; Phone Number: 0320445962; Email: madeleine.aumar@chru-lille.fr

Study Locations

• France
  • Lille, France, 59037
    • Hôpital Jeanne de Flandres
    • Principal Investigator: Madelaine AUMAR, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; All children born at the Lille University Hospital during the investigation period with esophageal atresia type III or IV	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Persistance of dumping syndrome	measured by a gastric emptying scintigraphy	At the age of 6 months
Tolerance of glucose monitoring	Occurrence of side effects or technical issues during monitoring	At least once during the 48 hours monitoring

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Groupement Interrégional de Recherche Clinique et d'Innovation; french patient association for oesophageal atresia AFAO
• Investigators: Principal Investigator: Madelaine AUMAR, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Oesophageal dysmotility; Oesophageal atresia; Post prandial hypoglycaemia; Gastric emptying troubles
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Congenital Abnormalities; Gastrointestinal Diseases; Stomach Diseases; Esophageal Diseases; Digestive System Abnormalities; Postgastrectomy Syndromes; Syndrome; Dumping Syndrome; Esophageal Atresia
• Other Study ID Numbers: 2019_51; 2020-A01938-31 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No