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Gastroesophageal RefluxReJejNCT05278689

Jejunal Feeding Via Gastrojejunal Tube in Refractory Gastroesophageal Reflux

An observational study of Gastroesophageal Reflux, run by Assistance Publique - Hôpitaux de Paris at 1 site 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

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… Read more about this study

Who is it for?
Ages 1 year to 18 years
Conditions the study is for
Gastroesophageal Reflux
How many people
40 participants
Where
1 siteFrance
Study dates
19 Nov 2021to 19 Nov 2022
Phase
Observational
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 1 year to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Hospitalized patients with more than 4 months follow-up

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Robert Debré Hospital - Assistance Publique Hopitaux de Paris

    Paris, 75019

Other trials in France

About this study

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.

Read more

References :

  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. 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. 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. Campwala I, Perrone E, Yanni G, Shah M, Gollin G. Complications of gastrojejunal feeding tubes in children. J Surg Res 2015; 199:67-71.
Read the detailed description

Gastroesophageal reflux disease (GERD) in children can be severe and lead to multiple complications, among them dizziness, esophagitis, respiratory failure or ENT infections. In the case of resistance o proton pump inhibitors (PPIs) therapy, alternatives treatments includes anti-reflux 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 at a young age.

As an alternative to anti-reflux surgery, prolonged parenteral nutrition (PN) 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 PN while waiting for spontaneous GERD improvement.

Literature data found 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 of the tube requiring replacement to jejunal perforation that is a life treating condition.

This monocentric, retrospective study will be conducted at a French pediatric university hospital. The study was approved by hospital's ethics committee and aims to help to evaluate the potential advantages of GJT feeding in hospital settings among patients admitted with severe GERD and determine if this feeding route may prevent or postpone recourse to invasive procedures like surgery or alternative nonsurgical treatments like parenteral nutrition (PN) that have morbidity in order to control the reflux disease and its complications and at the same time prevent growth deficit among affected children.

The data will be entered on an e-CRF (Epidata) from the patient files consulted on site by the investigators or a person delegated by them. The data will be anonymized when entered with only the order number, initials and year of birth of the patients. The correspondence table will be kept in each participating center by the local investigator. Only professionals involved in this study will have access to the pseudonymised database. Data will be recorded on a restricted access server. Persons with direct access to the data take all necessary precautions to ensure the confidentiality of this data. The anonymized data will be stored on secure servers not connected to the Internet.

The quantitative variables will be described in mean and standard deviation. Qualitative variables will be described in numbers (percent). Comparison tests. Qualitative data will be analyzed with Chi2 or Fischer's exact test. The qualitative values will be analyzed using Student's t-test if their distribution is normal or by the non-parametric Mann-Whitney test. Multivariate analysis will use logistic regression to study age, weight and initial pathology. The significance threshold was set at p < 0.05

The primary outcomes are :

Need for invasive GERD treatments, anti-reflux surgery or parenteral nutrition 1 month after Gastrojejunal tube placement and at the end of follow-up.

Secondary outcomes are:

Duration of use of Gastrojejunal tube. type of the Gastrojejunal tube

The following criteria will be compared before and after the installation of Gastrojejunal tube :

  • Anti-reflux treatments
  • Complications of GERD: respiratory, dizziness
  • Duration of hospitalization
  • Intussusception, Dumping syndrome,
  • Mechanical complications: obstruction, extrajejunal displacement, extraction, rupture of the GJT
  • Weight and height

References :

  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. 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. 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. Campwala I, Perrone E, Yanni G, Shah M, Gollin G. Complications of gastrojejunal feeding tubes in children. J Surg Res 2015; 199:67-71.
Being tested
No intervention
Keywords
Gastrojejunal, Children, GERD (Gastroesophageal reflux disease)
Medical subject headings
Gastroesophageal Reflux

What participants receive

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

  • No interventionOther

    No intervention

What is being measured

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

  1. GERD "Gastroesophageal Reflux Disease" treatments

    Need for invasive GERD treatments

    Measured: 4 months

Timeline

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

  1. First posted14 Mar 2022
  2. Study start19 Nov 2021
  3. Primary completion19 Nov 2022
  4. Study completion19 Nov 2022

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05278689
Sponsor's protocol ID
APHP-ReJej
Acronym
ReJej
Status last verified
Nov 2026
First submitted
4 Mar 2022
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37477887

Questions about this trial

What is this clinical trial studying?

An observational study of Gastroesophageal Reflux, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 4 inclusion and 2 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

GERD "Gastroesophageal Reflux Disease" treatments (time frame: 4 months). 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 NCT05278689, which also lists 1 linked publication.

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 6 Nov 2026.

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