Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03619408
Other study ID # P00029371
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2019
Est. completion date July 2025

Study information

Verified date September 2021
Source Boston Children's Hospital
Contact Michael Manfredi, MD
Phone 617-355-3038
Email michael.manfredi@childrens.harvard.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

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. For the remainder of the protocol, "year-1" refers to the initial set of testing/procedures/clinic visits occurring during the study period. "Year-2" refers to the second set of routine testing/procedures/clinic 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 and/or erosive esophagitis and/or 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 (e.g. 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 Barrett's esophagus, erosive esophagitis on endoscopy, and rates of BRUEs, respiratory infections, hospitalizations, and need for dilations


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers
Gender All
Age group N/A to 17 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Patients with jejunal or colonic interpositions

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Antacids
Omeprazole 1 mg/kg/dose BID or Omeprazole 1mg/kg/dose BID plus Ranitidine 3 mg/kg/dose BID

Locations

Country Name City State
United States Boston Children's Hospital Boston Massachusetts
United States Boston Childrens Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

Krishnan U, Mousa H, Dall'Oglio L, Homaira N, Rosen R, Faure C, Gottrand F. ESPGHAN-NASPGHAN Guidelines for the Evaluation and Treatment of Gastrointestinal and Nutritional Complications in Children With Esophageal Atresia-Tracheoesophageal Fistula. J Pediatr Gastroenterol Nutr. 2016 Nov;63(5):550-570. — View Citation

Miyake H, Chen Y, Hock A, Seo S, Koike Y, Pierro A. Are prophylactic anti-reflux medications effective after esophageal atresia repair? Systematic review and meta-analysis. Pediatr Surg Int. 2018 May;34(5):491-497. doi: 10.1007/s00383-018-4242-4. Epub 2018 Mar 13. Review. — View Citation

Pinheiro PF, Simões e Silva AC, Pereira RM. Current knowledge on esophageal atresia. World J Gastroenterol. 2012 Jul 28;18(28):3662-72. doi: 10.3748/wjg.v18.i28.3662. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Esophagitis Histologic esophagitis score graded as none, mild, moderate or severe 2 years
Secondary Esophagitis (macroscopic) Erosive esophagitis score graded according to LA classification 2 years
Secondary Barrett's esophagus Presence of intestinal metaplasia (Barrett's esophagus) on esophageal biopsies 2 years
Secondary Hospitalizations Need for intercurrent hospitalization for any reason 2 years
See also
  Status Clinical Trial Phase
Completed NCT00284908 - Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers Phase 1
Completed NCT00272818 - Study to Identify Non-Invasive Markers of Gastrointestinal Allergy
Recruiting NCT05326113 - The Effect of Physiotherapy on Post POEM Reflux N/A
Recruiting NCT01696734 - Domperidone in Treating Patients With Gastrointestinal Disorders Phase 3
Terminated NCT02575391 - The Effects of Whole Food Intervention on Mucositis in Patients Treated for Thoracic Cancer Phase 1/Phase 2
Completed NCT00256529 - Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia N/A
Completed NCT00123630 - A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab Phase 2
Completed NCT00081315 - Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer Phase 2
Completed NCT00471094 - Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive Esophagitis Phase 2
Completed NCT00579410 - Comparison of Acid Reflux at Two Levels in the Esophagus Using the BRAVO Capsule N/A
Recruiting NCT05109819 - Esophagus-sparing Radiotherapy for Metastatic Spinal Cord Compression. N/A
Withdrawn NCT01824199 - CYP2C19 Genotype Predictor of Gastric Acid Suppression Early Phase 1
Completed NCT01556919 - Esophageal Monitoring Device for Assessing Mucosal Impedance
Active, not recruiting NCT03835663 - The Bacterial Composition of the Stomach in Reflux Disease
Completed NCT00195208 - Study Comparing a Pantoprazole Formulation to the Currently Marketed Tablet for GERD and Erosive Esophagitis Phase 3
Completed NCT00175045 - Intravenous vs Oral Lansoprazole on Gastric Acid Secretion in Subjects With Erosive Esophagitis Phase 2
Completed NCT05129670 - Clinical Investigation to Assess the Acid Neutralisation Activity of a Calcite Chewing Gum N/A
Recruiting NCT05004155 - Twenty Four Hour Ambulatory pH & Impedance Testing: Normative Data for Indian Population
Completed NCT03228147 - Sensory Evaluation of Oral Nutrition Supplements in Patients at Risk for Mucositis Undergoing Cancer Treatment N/A
Completed NCT01322633 - Risk of Cancer Among Pantoprazole Users N/A