Dumping Syndrome and Esophageal Atresia (DUMTORING)
Primary Purpose
Oesophageal Atresia, Dumping Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Glycemic Holter
gastric emptying scintigraphy
Holter ECG
Sponsored by
About this trial
This is an interventional other trial for Oesophageal Atresia focused on measuring Oesophageal dysmotility, Oesophageal atresia, Post prandial hypoglycaemia, Gastric emptying troubles
Eligibility Criteria
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
Sites / Locations
- Hôpital Jeanne de Flandres
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental group
Arm Description
All children born at the Lille University Hospital during the investigation period with esophageal atresia type III or IV
Outcomes
Primary Outcome Measures
Abnormal glycaemia associated with vagal hypertonia
Composite criteria: association between abnormal glycaemia (high or low) and variations of cardiac frequency
Secondary Outcome Measures
Abnormal glycaemia associated with abnormal gastric emptying
Composite criteria: association between abnormal glycaemia (high or low) and abnormal gastric emptying study
Persistance of dumping syndrome
measured by a gastric emptying scintigraphy
Tolerance of glucose monitoring
Occurrence of side effects or technical issues during monitoring
Full Information
NCT ID
NCT04522193
First Posted
August 18, 2020
Last Updated
April 22, 2021
Sponsor
University Hospital, Lille
Collaborators
Groupement Interrégional de Recherche Clinique et d'Innovation, french patient association for oesophageal atresia AFAO
1. Study Identification
Unique Protocol Identification Number
NCT04522193
Brief Title
Dumping Syndrome and Esophageal Atresia
Acronym
DUMTORING
Official Title
Physiopathology of Dumping Syndrome in Esophageal Atresia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Groupement Interrégional de Recherche Clinique et d'Innovation, french patient association for oesophageal atresia AFAO
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oesophageal Atresia, Dumping Syndrome
Keywords
Oesophageal dysmotility, Oesophageal atresia, Post prandial hypoglycaemia, Gastric emptying troubles
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
All children born at the Lille University Hospital during the investigation period with esophageal atresia type III or IV
Intervention Type
Device
Intervention Name(s)
Glycemic Holter
Intervention Description
Continuous glycaemia monitoring,
Intervention Type
Radiation
Intervention Name(s)
gastric emptying scintigraphy
Intervention Description
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
Device
Intervention Name(s)
Holter ECG
Intervention Description
continuous cardiac monitoring
Primary Outcome Measure Information:
Title
Abnormal glycaemia associated with vagal hypertonia
Description
Composite criteria: association between abnormal glycaemia (high or low) and variations of cardiac frequency
Time Frame
At least once during the 48 hours monitoring
Secondary Outcome Measure Information:
Title
Abnormal glycaemia associated with abnormal gastric emptying
Description
Composite criteria: association between abnormal glycaemia (high or low) and abnormal gastric emptying study
Time Frame
At least once during the 48 hours monitoring
Title
Persistance of dumping syndrome
Description
measured by a gastric emptying scintigraphy
Time Frame
At the age of 6 months
Title
Tolerance of glucose monitoring
Description
Occurrence of side effects or technical issues during monitoring
Time Frame
At least once during the 48 hours monitoring
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madelaine AUMAR, MD
Phone
0320445962
Email
madeleine.aumar@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madelaine AUMAR, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Jeanne de Flandres
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Contact:
Phone
0320445962
First Name & Middle Initial & Last Name & Degree
Madelaine AUMAR, MD
12. IPD Sharing Statement
Learn more about this trial
Dumping Syndrome and Esophageal Atresia
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