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临床试验/NCT05278689
NCT05278689Unknown不适用

Jejunal Feeding Via Gastrojejunal Tube in Refractory Gastroesophageal Reflux

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年11月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
GERD "Gastroesophageal Reflux Disease" treatments

研究概览

简要总结

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. 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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

GERD "Gastroesophageal Reflux Disease" treatments

时间窗: 4 months

Need for invasive GERD treatments

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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