Ignite Creation Date:
2024-05-06 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03619408
Status:
RECRUITING
Last Update Posted:
2021-09-10
First Post:
2018-08-02
Brief Title:
Management of Esophagitis Following Repair of Esophageal Atresia
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Management of Esophagitis Following Repair of Esophageal Atresia
Status:
RECRUITING
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
A Specific AimsObjectives 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 Childrens 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 Childrens Hospital who have undergone primary anastomosis repair of esophageal atresia beginning upon IRB approval
For the remainder of the protocol year-1 refers to the initial set of testingproceduresclinic visits occurring during the study period Year-2 refers to the second set of routine testingproceduresclinic visits occurring approximately one year after the year-1 time point
Inclusion Criteria All repaired esophageal atresia patients with primary esophageal anastomosis are eligible to enroll at the time of their routine year-1 surveillance endoscopy pH-impedance studies
For patients with histology showing no or mild esophagitis no erosive esophagitis and reflux index 3 on pH-metry antacid therapy will be discontinued
For patients with histology showing moderate or severe esophagitis andor erosive esophagitis andor reflux index 3 on pH-metry antacid therapy with PPI will be initiated For patients already taking PPI at therapeutic dosing an H2 blocker will be added
Data collection will include
Clinical history including age at enrollment gender esophageal atresia type date of esophageal atresia repair associated anomalies history of prematurity history of anastomotic leak history of prior esophageal dilations history of gastrostomy tube placement history of fundoplication hiatal hernia
Medication history
Symptom questionnaire at enrollment and at 1 year post-enrollment
pH-Impedance data including reflux index retrograde bolus movements mean acid clearance time mean bolus clearance time and proximal events at enrollment and at 1 year post-enrollment
Endoscopic findings as well as data from interventions eg dilations injections at enrollment and at 1 year post-enrollment
Histology from esophageal biopsies
Outcome data including primary outcome histologic esophagitis severity and secondary outcomes including presence of Barretts esophagus erosive esophagitis on endoscopy and rates of BRUEs respiratory infections hospitalizations and need for dilations
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 Childrens 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 Childrens Hospital who have undergone primary anastomosis repair of esophageal atresia beginning upon IRB approval
For the remainder of the protocol year-1 refers to the initial set of testingproceduresclinic visits occurring during the study period Year-2 refers to the second set of routine testingproceduresclinic visits occurring approximately one year after the year-1 time point
Inclusion Criteria All repaired esophageal atresia patients with primary esophageal anastomosis are eligible to enroll at the time of their routine year-1 surveillance endoscopy pH-impedance studies
For patients with histology showing no or mild esophagitis no erosive esophagitis and reflux index 3 on pH-metry antacid therapy will be discontinued
For patients with histology showing moderate or severe esophagitis andor erosive esophagitis andor reflux index 3 on pH-metry antacid therapy with PPI will be initiated For patients already taking PPI at therapeutic dosing an H2 blocker will be added
Data collection will include
Clinical history including age at enrollment gender esophageal atresia type date of esophageal atresia repair associated anomalies history of prematurity history of anastomotic leak history of prior esophageal dilations history of gastrostomy tube placement history of fundoplication hiatal hernia
Medication history
Symptom questionnaire at enrollment and at 1 year post-enrollment
pH-Impedance data including reflux index retrograde bolus movements mean acid clearance time mean bolus clearance time and proximal events at enrollment and at 1 year post-enrollment
Endoscopic findings as well as data from interventions eg dilations injections at enrollment and at 1 year post-enrollment
Histology from esophageal biopsies
Outcome data including primary outcome histologic esophagitis severity and secondary outcomes including presence of Barretts esophagus erosive esophagitis on endoscopy and rates of BRUEs respiratory infections hospitalizations and need for dilations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None