Esophagitis Clinical Trial
Official title:
Management of Esophagitis Following Repair of Esophageal Atresia
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
United States | Boston Childrens Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital |
United States,
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
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 |
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