跳至主要内容
临床试验/NCT03619408
NCT03619408招募中不适用

Management of Esophagitis Following Repair of Esophageal Atresia

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Esophagitis

研究概览

简要总结

The goal of this study is to prospectively evaluate the impact of antacid therapy on esophagitis in children with repaired esophageal atresia. Recent clinical guidelines have attempted to define a systematic approach to the management of these patients with regards to minimizing and treating esophagitis (Krishnan et al 2016), however the quality of evidence supporting many of the recommendations are based on expert opinion or on limited, retrospective studies. Risk factors for esophagitis and optimal length of antacid therapy are not well defined. Through this study, we aim to identify risk factors for the presence of esophagitis in patients with repaired esophageal atresia. We hypothesize that antacid therapy improves esophagitis severity in children following esophageal repair.

详细描述

A. Specific Aims/Objectives The goal of this study is to prospectively evaluate the impact of antacid therapy on esophagitis in children with repaired esophageal atresia. Recent clinical guidelines have attempted to define a systematic approach to the management of these patients with regards to minimizing and treating esophagitis (Krishnan et al 2016), however the quality of evidence supporting many of the recommendations are based on expert opinion or on limited, retrospective studies. Risk factors for esophagitis and optimal length of antacid therapy are not well defined. Through this study, we aim to identify risk factors for the presence of esophagitis in patients with repaired esophageal atresia. We hypothesize that antacid therapy improves esophagitis severity in children following esophageal repair.

B. Background and Significance

Esophageal atresia is one of the most common congenital gastrointestinal anomalies and affects 1 in 2500 to 1 in 4000 live births (Pinheiro et al 2012; Krishnan et al 2016). Recent ESPGHAN-NASPGHAN guidelines have attempted to define a systematic approach to the post-operative management of these patients with regards to minimizing and treating esophagitis, anastomotic strictures, and feeding difficulties (Krishnan et al 2016), however the quality of evidence supporting many of the recommendations are based on expert opinion or on limited, retrospective studies. For example, there are no controlled studies describing benefit of systematic acid suppression on outcomes such as esophagitis or associated long-term sequelae such as esophageal stricture. While esophagitis in these patients has been presumed to be related to high rates of acid reflux, it is unclear that antacid therapy leads to reduced rates of esophagitis or its complications. A recent meta-analysis of four observational studies suggests that antacid therapy with PPI is not associated with lower rates of esophageal strictures (Miyake et al 2018). Boston Children's Hospital Esophageal and Airway Treatment Center has one of the largest cohorts of children with esophageal atresia in the United States with the opportunity to study the impact of antacid therapy in management of esophagitis in repaired esophageal atresia.

C. Design and Methods

Prospective analysis of inpatient and ambulatory pediatric patients and their medical records at Boston Children's Hospital who have undergone primary anastomosis repair of esophageal atresia beginning upon IRB approval.

研究设计

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

入排标准

年龄范围
30 Days 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All repaired esophageal atresia patients with primary esophageal anastomosis treated at Boston Children's Hospital are eligible to enroll before or at year-1 surveillance endoscopy

排除标准

  • Patients with jejunal or colonic interpositions

研究组 & 干预措施

Moderate/Severe Esophagitis

All repaired esophageal atresia patients at Boston Children's Hospital with primary esophageal anastomosis undergoing routine year-1 surveillance endoscopy / pH-impedance studies found to have moderate or severe histologic esophagitis, and/or erosive esophagitis, and/or reflux index > 3% on pH-metry.

Antacid therapy with PPI (omeprazole 1mg/kg/dose BID) will be initiated. For patients already taking PPI at therapeutic dosing, an H2 blocker (ranitidine 3mg/kg/dose BID) will be added.

干预措施: Antacids (Drug)

结局指标

主要结局

Esophagitis

时间窗: 2 years

Histologic esophagitis score graded as none, mild, moderate or severe

次要结局

  • Barrett's esophagus(2 years)
  • Hospitalizations(2 years)
  • Esophagitis (macroscopic)(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael A. Manfredi, MD

Assistant Professor of Pediatrics, Harvard Medical School

Boston Children's Hospital

研究点 (2)

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