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

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.

Study Overview

• Status: Completed
• Conditions: Dumping Syndrome; Oesophageal Atresia
• Intervention / Treatment: Biological: Oral Glucose

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• 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: Every EA patients; This is a one group interventional study. Every patient is included in the same arm.	Biological: Oral Glucose; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early hyperglycemia during Oral Glucose Tolerance Test (OGTT)	Hypoglycemia : glycemia < 0,6 g/L	up to 240 min
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	up to 240 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	continuous monitoring during 240 minutes
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.	1 day
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	1 day
Post-surgery complications	anastomotic leakage, mediastinitis	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2011
• Primary Completion (Actual): January 15, 2018
• Study Completion (Actual): January 15, 2018

Study Registration Dates

• First Submitted: August 14, 2015
• First Submitted That Met QC Criteria: August 14, 2015
• First Posted (Estimate): August 17, 2015

Study Record Updates

• Last Update Posted (Actual): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: infants; prevalence; Oral glucose tolerance test; oesophageal atresia; dumping syndrome; Type III and IV; early hyperglycemia; late hypoglycemia
• 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: 2009_42/1004; 2010-A00217-32 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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