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
|Condition or disease||Intervention/treatment|
|Esophageal Atresia Esophagitis||Drug: Antacids|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||50 participants|
|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|
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.
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.
Omeprazole 1 mg/kg/dose BID or Omeprazole 1mg/kg/dose BID plus Ranitidine 3 mg/kg/dose BID
- Esophagitis [ Time Frame: 2 years ]Histologic esophagitis score graded as none, mild, moderate or severe
- Esophagitis (macroscopic) [ Time Frame: 2 years ]Erosive esophagitis score graded according to LA classification
- Barrett's esophagus [ Time Frame: 2 years ]Presence of intestinal metaplasia (Barrett's esophagus) on esophageal biopsies
- Hospitalizations [ Time Frame: 2 years ]Need for intercurrent hospitalization for any reason
Biospecimen Retention: Samples Without DNA
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
|Contact: Michael Manfredi, MDfirstname.lastname@example.org|
|Contact: Jessica Yasuda, MDemail@example.com|