Jejunal Feeding Via Gastrojejunal Tube in Refractory Gastroesophageal Reflux

NCT05278689 | Unknown

• 1 other identifier: APHP-ReJej
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Gastroesophageal reflux disease (GERD) in children can be severe and lead to multiple complications, dizziness, esophagitis, respiratory failure or ENT infections. In the case of resistance to treatment with proton pump inhibitors (PPIs), alternatives treatments includes antireflux surgery or fasting associated with parenteral nutrition. The use of gastrointestinal tubes (GJT) is relatively recent. Its objective is to allow a direct jejunal feeding, thus limiting the risk of severe gastroesophageal reflux disease (GERD). Jejunal feeding using GJT has been compared to surgical techniques without finding any superiority. However, the risk of GERD recurrence appears to be greater if anti-reflux surgery is performed in a young child. As an alternative to anti-reflux surgery, prolonged parenteral nutrition (NPE) is burdened with its own morbidity (metabolic, infectious, vascular). In addition, the natural course of GERD is usually towards spontaneous improvement with the age and growth of the child. GJT may be used to postpone anti-reflux surgery and prevent NPE while waiting for spontaneous GERD improvement. In a cohort of 27 children, 5 did not require surgery or parenteral nutrition after placement of GJT . However, this study is difficult to analyze because of 9/27 deaths. Complications from GJT are common, ranging from obstruction requiring replacement to jejunal perforation. We will study the benefit of jejunal feeding on YSG for children followed for severe GERD. References :

1. 1.Srivastava R, Downey EC, O'Gorman M, Feola P, Samore M, Holubkov R, et al. Impact of fundoplication versus gastrojejunal feeding tubes on mortality and in preventing aspiration pneumonia in young children with neurologic impairment who have gastroesophageal reflux disease. Pediatrics 2009; 123:338-45.
2. 2.Stone B, Hester G, Jackson D, Richardson T, Hall M, Gouripeddi R, et al. Effectiveness of Fundoplication or Gastrojejunal Feeding in Children With Neurologic Impairment. Hosp Pediatr 2017; 7:140-8.
3. 3.Michaud L, Coopman S, Guimber D, Sfeir R, Turck D, Gottrand F. Percutaneous gastrojejunostomy in children: efficacy and safety. Arch Dis Child 2012; 97:733-4.
4. 4.Campwala I, Perrone E, Yanni G, Shah M, Gollin G. Complications of gastrojejunal feeding tubes in children. J Surg Res 2015; 199:67-71.

Conditions

Gastroesophageal Reflux

Keywords

Gastrojejunal; Children; GERD (Gastroesophageal reflux disease)

Outcome Measures

Primary Outcomes (1)

• GERD "Gastroesophageal Reflux Disease" treatments

  Need for invasive GERD treatments

  4 months

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients with more than 4 months follow-up

You may qualify if:

• Children under 18
• Insertion of a gastro-jejunal tube with a goal of feeding by the jejunal route during GERD beyond 1/1/2000
• Follow-up\> 4 months.
• Follow-up at Robert-Debré hospital

You may not qualify if:

• Refusal to participate in the study
• intra-gastric Gastro-jejunal tube placement, with the aim of gastric emptying

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Robert Debré Hospital - Assistance Publique Hopitaux de Paris

Paris, 75019, France

RECRUITING

Related Publications (1)

• Faccioli N, Sierra A, Mosca A, Bellaiche M, Lengline H, Bonnard A, Viala J. Jejunal Feeding by Gastrojejunal Tube in Pediatric Refractory Gastroesophageal Reflux Disease. J Pediatr Gastroenterol Nutr. 2023 Aug 1;77(2):267-273. doi: 10.1097/MPG.0000000000003785. Epub 2023 Mar 31.

  PMID: 37477887 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Jerome VIALA, MD, PhD

CONTACT

+33140035712; jerome.viala@aphp.fr

Naim DRID, MD

CONTACT

+33140035712; naim.drid@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 14, 2022
• Study Start: November 19, 2021
• Primary Completion: November 19, 2022
• Study Completion: November 19, 2022
• Last Updated: March 14, 2022

Record last verified: 2022-02

Locations

FR (1)