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CompletedNCT05278689ClinicalTrials.gov record

Jejunal Feeding Via Gastrojejunal Tube in Refractory Gastroesophageal Reflux

Gastroesophageal Reflux

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Observational
Phase
Not applicable / not listed
Age range
1 years - 18 years
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
40 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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. The investigators will study the benefit of jejunal feeding on YSG for children followed for severe GERD.

Read the full 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

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study population

Hospitalized patients with more than 4 months follow-up

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not reported
Masking
Not reported
No intervention OTHER

No intervention

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

GERD "Gastroesophageal Reflux Disease" treatments

Time frame: 4 months

Need for invasive GERD treatments

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Robert Debré Hospital - Assistance Publique Hopitaux de ParisParis, FranceStatus unknown

Study team and timeline

Lead sponsor
Assistance Publique - Hôpitaux de Paris
Study start
Nov 19, 2021 Actual
Primary completion
Nov 19, 2022 Actual
Study completion
Nov 19, 2022 Actual
First posted
Mar 14, 2022 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

Jejunal Feeding Via Gastrojejunal Tube in Refractory Gastroesophageal Reflux

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026