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Oesophageal AtresiaDUMPINGNCT02525705

Dumping Syndrome After Operation of Esophageal Atresia Type III

A study testing Oral Glucose in people with Oesophageal Atresia and Dumping Syndrome, run by University Hospital, Lille at 10 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 14 weeks
Conditions the study is for
Oesophageal Atresia, Dumping Syndrome
What is being tested?
Oral Glucose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
10 sitesFrance
Study dates
14 Jun 2011to 15 Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 14 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Absence of consent
  • Patient judiciary protected
  • Simultaneous participation to another clinical trial
  • No health insurance

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

France10 sites

  • Hôpital Pellegrin - Hôpital d'Enfants,

    Bordeaux

  • CHU Grenoble

    Grenoble

  • Hôpital Jeanne de Flandre CHRU

    Lille

  • Hôpital Edouard Herriot,Unité d'Hépatogastroentérologie et Nutrition Pédiatriques

    Lyon

  • CHU Nantes

    Nantes

  • AP-HP, Hôpital Necker

    Paris

  • Hôpital Robert Debré ,Service de chirurgie viscérale et urologique

    Paris

  • CHU Rouen

    Rouen

  • CHU Strasbourg

    Strasbourg

  • CHU Toulouse, Hôpital Enfant

    Toulouse

Other trials in France

About this study

Official title: Frequency of Occurrence of Dumping Syndrome After Operation of Esophageal Atresia Type III

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.

Read the 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.

Being tested
Oral Glucose
Keywords
infants, oesophageal atresia, dumping syndrome, prevalence, Type III and IV, Oral glucose tolerance test, early hyperglycemia, late hypoglycemia
Medical subject headings
Esophageal Atresia, Dumping Syndrome, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral GlucoseBiological

    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.

Study groups in NCT02525705
Study groupRoleWhat they receive
Every EA patientsExperimentalThis is a one group interventional study. Every patient is included in the same arm.
Receives: Biological: Oral Glucose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Early hyperglycemia during Oral Glucose Tolerance Test (OGTT)

    Hypoglycemia : glycemia < 0,6 g/L

    Measured: up to 240 min

  2. 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

    Measured: up to 240 min

Secondary outcomes (4)

  1. 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

    Measured: continuous monitoring during 240 minutes

  2. 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.

    Measured: 1 day

  3. 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

    Measured: 1 day

  4. Post-surgery complications

    anastomotic leakage, mediastinitis

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2015 (estimated)
  2. Study start14 Jun 2011
  3. Primary completion15 Jan 2018
  4. Study completion15 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02525705
Sponsor's protocol ID
2009_42/1004
Other IDs
2010-A00217-32
Acronym
DUMPING
Status last verified
Aug 2019
First submitted
14 Aug 2015
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32443041

  • 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.

    PubMed 11527163

  • 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.

    PubMed 8890072

  • 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.

    PubMed 12948306

  • 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.

    PubMed 11743518

  • 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.

    PubMed 20385264

  • 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.

    PubMed 17638154

Questions about this trial

What is this clinical trial studying?

A study testing Oral Glucose in people with Oesophageal Atresia and Dumping Syndrome, run by University Hospital, Lille at 10 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early hyperglycemia during Oral Glucose Tolerance Test (OGTT) (time frame: up to 240 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02525705, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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