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Management of Esophagitis Following Repair of Esophageal Atresia

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ClinicalTrials.gov Identifier: NCT03619408
Recruitment Status : Not yet recruiting
First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Michael A. Manfredi, MD, Boston Children’s Hospital

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.

Condition or disease Intervention/treatment
Esophageal Atresia Esophagitis Drug: Antacids

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Management of Esophagitis Following Repair of Esophageal Atresia
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020


Group/Cohort Intervention/treatment
No/Mild 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 no or mild histologic esophagitis, no erosive esophagitis, and reflux index <3% on pH-metry. Antacid therapy will be discontinued.
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.

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




Primary Outcome Measures :
  1. Esophagitis [ Time Frame: 2 years ]
    Histologic esophagitis score graded as none, mild, moderate or severe


Secondary Outcome Measures :
  1. Esophagitis (macroscopic) [ Time Frame: 2 years ]
    Erosive esophagitis score graded according to LA classification

  2. Barrett's esophagus [ Time Frame: 2 years ]
    Presence of intestinal metaplasia (Barrett's esophagus) on esophageal biopsies

  3. Hospitalizations [ Time Frame: 2 years ]
    Need for intercurrent hospitalization for any reason


Biospecimen Retention:   Samples Without DNA
esophageal biopsies obtained with cold forceps during routine surveillance endoscopies


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Pediatric esophageal atresia patients with primary esophageal anastomosis at Boston Children's Hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619408


Contacts
Contact: Michael Manfredi, MD 617-355-3038 michael.manfredi@childrens.harvard.edu
Contact: Jessica Yasuda, MD 617-355-3038 jessica.yasuda@childrens.harvard.edu

Sponsors and Collaborators
Boston Children’s Hospital

Publications:
Responsible Party: Michael A. Manfredi, MD, Assistant Professor of Pediatrics, Harvard Medical School, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03619408     History of Changes
Other Study ID Numbers: P00029371
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael A. Manfredi, MD, Boston Children’s Hospital:
Esophageal Atresia
Esophagitis
GER
Gastroesopheal reflux
PPI

Additional relevant MeSH terms:
Esophagitis
Esophageal Atresia
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Digestive System Abnormalities
Congenital Abnormalities
Antacids
Anti-Ulcer Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents