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.
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
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 :
- 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.
- 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.
- 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.
- 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 :
- 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.
- 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.
- 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.
- 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
- 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.
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.
- First posted14 Mar 2022
- Study start19 Nov 2021
- Primary completion19 Nov 2022
- Study completion19 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jejunal Feeding Via Gastrojejunal Tube in Refractory Gastroesophageal Reflux
- ClinicalTrials.gov ID
- NCT05278689
- Acronym / sponsor ID
- ReJej / APHP-ReJej
- Conditions
- Gastroesophageal Reflux
- Keywords
- Gastrojejunal, Children, GERD (Gastroesophageal reflux disease)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 19 Nov 2022 (actual)
- Study completion
- 19 Nov 2022 (actual)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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.
- 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.
- 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.
- Campwala I, Perrone E, Yanni G, Shah M, Gollin G. Complications of gastrojejunal feeding tubes in children. J Surg Res 2015; 199:67-71.
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 :
- 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.
- 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.
- 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.
- Campwala I, Perrone E, Yanni G, Shah M, Gollin G. Complications of gastrojejunal feeding tubes in children. J Surg Res 2015; 199:67-71.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Hospitalized patients with more than 4 months follow-up
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Refusal to participate in the study
- intra-gastric Gastro-jejunal tube placement, with the aim of gastric emptying
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
GERD "Gastroesophageal Reflux Disease" treatments
Time frame: 4 months
Need for invasive GERD treatments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Derived from this study: PubMed 37477887Faccioli 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.