Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair

Not Applicable

• Conditions: Esophageal Atresia
• Interventions: Device: Pediatric endoscopic ultrasound

• Registration Number: NCT04259528
• Lead Sponsor: Boston Children's Hospital

Brief Summary

Children with esophageal atresia who undergo surgical repair are at risk for anastomotic stricture following surgery. Esophageal stricture can be treated with serial endoscopic dilation but may ultimately need surgical resection if the stricture proves refractory to therapy. Several risk factors have been reported for development of recalcitrant stricture, but to date, no studies have specifically examined the relationship between anastomotic thickness and echotexture at time of initial postoperative endoscopy and treatment outcomes. Other risk factors that have been implicated in the development of recalcitrant stricture include gastroesophageal reflux disease, anastomotic leak, long-gap esophageal atresia, and gestational age. Moreover, it is poorly understood how esophageal layers alter and progress with repeated therapeutic dilation. The investigator hypothesize that the initial thickness and echotexture will help determine therapeutic outcome. It will also help us understand the progression of esophageal echotexture following therapeutic dilation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-06
• Status Verified: 2020-03
• Study Start: 2020-03-01
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-05
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients ages 0-21 years old at time of evaluation with a suspected diagnosis of esophageal stricture secondary to esophageal atresia (with or without Tracheoesophageal fistula) post surgical repair

Exclusion Criteria

• Patients with pre-diagnosis of eosinophilic esophagitis
• Patients with pre-diagnosis of congenital esophageal stricture
• Patients diagnosed with esophageal stricture secondary to caustic ingestion
• Patient is diagnosed with an esophageal perforation at time of endoscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with esophageal stricture following surgical repair	Pediatric endoscopic ultrasound	Patients with esophageal atresia following surgical repair who developed an esophageal stricture

Primary Outcome Measures

Name	Time	Method
Predict post surgical primary repair outcome in patients with esophageal atresia using endoscopic ultrasound	2 years	Patients with esophageal atresia following surgical repair will undergo an endoscopic ultrasound procedure to measure esophageal layer thickness and to describe esophageal echo-texture characteristics at the anastomotic site