Dumping Syndrome After Operation of Esophageal Atresia Type III

Dumping Syndrome Clinical Trial

— DUMPING  

Official title:

Frequency of Occurrence of Dumping Syndrome After Operation of Esophageal Atresia Type III

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02525705
• Other study ID #: 2009_42/1004
• Secondary ID: 2010-A00217-32
• Status: Completed
• Phase: N/A
• Start date: June 14, 2011
• Est. completion date: January 15, 2018

Study information

• Verified date: August 2019
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 15, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Dumping Syndrome
• Esophageal Atresia
• Oesophageal Atresia
• Syndrome

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

References & Publications (6)

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. — View Citation

Holschneider P, Dübbers 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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early hyperglycemia during Oral Glucose Tolerance Test (OGTT)	Hypoglycemia : glycemia < 0,6 g/L	up to 240 min
Primary	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	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
Secondary	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
Secondary	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
Secondary	Post-surgery complications	anastomotic leakage, mediastinitis	1 day