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Dumping Syndrome After Operation of Esophageal Atresia Type III (DUMPING)

Primary Purpose

Oesophageal Atresia, Dumping Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Oral Glucose
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oesophageal Atresia focused on measuring infants, oesophageal atresia, dumping syndrome, prevalence, Type III and IV, Oral glucose tolerance test, early hyperglycemia, late hypoglycemia

Eligibility Criteria

undefined - 14 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • New born less than 3.5 months or age corrected for premature new born
  • Weight ≥ 4, 150 kg
  • Esophageal atresia (EA) type III or IV
  • EA Surgery between May 2013 and June 2016
  • Stop of prokinetic treatment > 72 h before OGTT
  • Information and consent of parents
  • Patients with health insurance

Exclusion Criteria:

  • Age > 3.5 months
  • Weight < 4.150 kg
  • Other types of EA
  • Dumping syndrom from other origin: microgastria, dysautonomia, small intestine surgery
  • Other pathology that can modify glycemia: neonatal diabete, hyperinsulinism
  • Treatment that can modify gastric motility: domperidone, erythromycin, baclofen that hasn't been stopped in the 72h before OGTT
  • Absence of consent
  • Patient judiciary protected
  • Simultaneous participation to another clinical trial
  • No health insurance

Sites / Locations

  • Hôpital Pellegrin - Hôpital d'Enfants,
  • CHU Grenoble
  • Hôpital Jeanne de Flandre CHRU
  • Hôpital Edouard Herriot,Unité d'Hépatogastroentérologie et Nutrition Pédiatriques
  • CHU Nantes
  • AP-HP, Hôpital Necker
  • Hôpital Robert Debré ,Service de chirurgie viscérale et urologique
  • CHU Rouen
  • CHU Strasbourg
  • CHU Toulouse, Hôpital Enfant

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Every EA patients

Arm Description

This is a one group interventional study. Every patient is included in the same arm.

Outcomes

Primary Outcome Measures

Early hyperglycemia during Oral Glucose Tolerance Test (OGTT)
Hypoglycemia : glycemia < 0,6 g/L
Late hypoglycemia during OGTT
Hyperglycemia : > 1,8g/L from H0 to 30 min after oral intake, > 1.7 between 1 and 2 h ours, > 1.4 between 2 and 3 h , > 1, 26 after 3 h

Secondary Outcome Measures

Clinical signs presenting consequently to OGTT
frequent clinical reflux (>3/day), suspicion of esophagitis (pain while eating), colics, post-prandial diarrhea (liquid stools in the first hour after meal), abdominal pain, flatulence, pallor, hypotonia, agitation, convulsions, somnolence, sweat
Associated pathologies
neurologic, extremities, ribbs and vertebrales, genito-urinary, renal, cardiovascular, ano-rectal, microgastria and others. Syndromic associations are also noted, as VACTERL and charge syndroms.
Surgery details
postponed anastomosis, difficulty or tension in the suture, colic or gastric plasty if needed, tracheoscopy realisation, visualisation or damage of the X nerve, observation of a microgastria during surgery, other relevant informations of surgery
Post-surgery complications
anastomotic leakage, mediastinitis

Full Information

First Posted
August 14, 2015
Last Updated
August 1, 2019
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT02525705
Brief Title
Dumping Syndrome After Operation of Esophageal Atresia Type III
Acronym
DUMPING
Official Title
Frequency of Occurrence of Dumping Syndrome After Operation of Esophageal Atresia Type III
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 14, 2011 (Actual)
Primary Completion Date
January 15, 2018 (Actual)
Study Completion Date
January 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the prevalence at 3.5 months of age of dumping syndrome in children operated at birth for oesophageal atresia type III et IV.
Detailed Description
Consecutive patients with type III and IV oesophageal atresia that are born in 8 different centers in France and Sydney (Australia) are included in the study, if willing. As soon as they weigh more than 4.150kg and if they are still younger than 3.5 months, an Oral Glucose Tolerance Test (OGTT) is performed. Glycemia and insulinemia are monitored every 30 minutes from intake to 240 minutes. Clinical signs that are presented are noted. If early hyperglycemia or late hypoglycemia are biologically or clinically observed, ascarbose treatment is initiated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oesophageal Atresia, Dumping Syndrome
Keywords
infants, oesophageal atresia, dumping syndrome, prevalence, Type III and IV, Oral glucose tolerance test, early hyperglycemia, late hypoglycemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Every EA patients
Arm Type
Experimental
Arm Description
This is a one group interventional study. Every patient is included in the same arm.
Intervention Type
Biological
Intervention Name(s)
Oral Glucose
Intervention Description
1.75g/kg of glucose is orally taken by the patient. Capillary glycemia is systematically realised before ingestion (H0) and after 30, 60, 90, 120, 180 and 240 min and/or if clinical signs of hypoglycemia are presented by the patient.
Primary Outcome Measure Information:
Title
Early hyperglycemia during Oral Glucose Tolerance Test (OGTT)
Description
Hypoglycemia : glycemia < 0,6 g/L
Time Frame
up to 240 min
Title
Late hypoglycemia during OGTT
Description
Hyperglycemia : > 1,8g/L from H0 to 30 min after oral intake, > 1.7 between 1 and 2 h ours, > 1.4 between 2 and 3 h , > 1, 26 after 3 h
Time Frame
up to 240 min
Secondary Outcome Measure Information:
Title
Clinical signs presenting consequently to OGTT
Description
frequent clinical reflux (>3/day), suspicion of esophagitis (pain while eating), colics, post-prandial diarrhea (liquid stools in the first hour after meal), abdominal pain, flatulence, pallor, hypotonia, agitation, convulsions, somnolence, sweat
Time Frame
continuous monitoring during 240 minutes
Title
Associated pathologies
Description
neurologic, extremities, ribbs and vertebrales, genito-urinary, renal, cardiovascular, ano-rectal, microgastria and others. Syndromic associations are also noted, as VACTERL and charge syndroms.
Time Frame
1 day
Title
Surgery details
Description
postponed anastomosis, difficulty or tension in the suture, colic or gastric plasty if needed, tracheoscopy realisation, visualisation or damage of the X nerve, observation of a microgastria during surgery, other relevant informations of surgery
Time Frame
1 day
Title
Post-surgery complications
Description
anastomotic leakage, mediastinitis
Time Frame
1 day

10. Eligibility

Sex
All
Maximum Age & Unit of Time
14 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: New born less than 3.5 months or age corrected for premature new born Weight ≥ 4, 150 kg Esophageal atresia (EA) type III or IV EA Surgery between May 2013 and June 2016 Stop of prokinetic treatment > 72 h before OGTT Information and consent of parents Patients with health insurance Exclusion Criteria: Age > 3.5 months Weight < 4.150 kg Other types of EA Dumping syndrom from other origin: microgastria, dysautonomia, small intestine surgery Other pathology that can modify glycemia: neonatal diabete, hyperinsulinism Treatment that can modify gastric motility: domperidone, erythromycin, baclofen that hasn't been stopped in the 72h before OGTT Absence of consent Patient judiciary protected Simultaneous participation to another clinical trial No health insurance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Michaud, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Pellegrin - Hôpital d'Enfants,
City
Bordeaux
Country
France
Facility Name
CHU Grenoble
City
Grenoble
Country
France
Facility Name
Hôpital Jeanne de Flandre CHRU
City
Lille
Country
France
Facility Name
Hôpital Edouard Herriot,Unité d'Hépatogastroentérologie et Nutrition Pédiatriques
City
Lyon
Country
France
Facility Name
CHU Nantes
City
Nantes
Country
France
Facility Name
AP-HP, Hôpital Necker
City
Paris
Country
France
Facility Name
Hôpital Robert Debré ,Service de chirurgie viscérale et urologique
City
Paris
Country
France
Facility Name
CHU Rouen
City
Rouen
Country
France
Facility Name
CHU Strasbourg
City
Strasbourg
Country
France
Facility Name
CHU Toulouse, Hôpital Enfant
City
Toulouse
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11527163
Citation
Bufler P, Ehringhaus C, Koletzko S. Dumping syndrome: a common problem following Nissen fundoplication in young children. Pediatr Surg Int. 2001 Jul;17(5-6):351-5. doi: 10.1007/s003830000525.
Results Reference
result
PubMed Identifier
8890072
Citation
Samuk I, Afriat R, Horne T, Bistritzer T, Barr J, Vinograd I. Dumping syndrome following Nissen fundoplication, diagnosis, and treatment. J Pediatr Gastroenterol Nutr. 1996 Oct;23(3):235-40. doi: 10.1097/00005176-199610000-00006.
Results Reference
result
PubMed Identifier
12948306
Citation
Zung A, Zadik Z. Acarbose treatment of infant dumping syndrome: extensive study of glucose dynamics and long-term follow-up. J Pediatr Endocrinol Metab. 2003 Jul-Aug;16(6):907-15. doi: 10.1515/jpem.2003.16.6.907.
Results Reference
result
PubMed Identifier
11743518
Citation
Ng DD, Ferry RJ Jr, Kelly A, Weinzimer SA, Stanley CA, Katz LE. Acarbose treatment of postprandial hypoglycemia in children after Nissen fundoplication. J Pediatr. 2001 Dec;139(6):877-9. doi: 10.1067/mpd.2001.119169.
Results Reference
result
PubMed Identifier
20385264
Citation
Michaud L, Sfeir R, Couttenier F, Turck D, Gottrand F. Dumping syndrome after esophageal atresia repair without antireflux surgery. J Pediatr Surg. 2010 Apr;45(4):E13-5. doi: 10.1016/j.jpedsurg.2010.01.016.
Results Reference
result
PubMed Identifier
17638154
Citation
Holschneider P, Dubbers M, Engelskirchen R, Trompelt J, Holschneider AM. Results of the operative treatment of gastroesophageal reflux in childhood with particular focus on patients with esophageal atresia. Eur J Pediatr Surg. 2007 Jun;17(3):163-75. doi: 10.1055/s-2007-965087.
Results Reference
result
PubMed Identifier
32443041
Citation
Aumar M, Gottrand F, Chalouhi C, Blanc S, Thomassin N, Piloquet H, Gastineau S, Schneider A, Krishnan U, Duvoisin G, Turck D, Coopman S, Michaud L. Frequency of Abnormal Glucose Tolerance Test Suggestive of Dumping Syndrome Following Oesophageal Atresia Repair. J Pediatr Gastroenterol Nutr. 2020 Jun;70(6):820-824. doi: 10.1097/MPG.0000000000002651.
Results Reference
derived

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Dumping Syndrome After Operation of Esophageal Atresia Type III

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