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Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair

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Boston Children's Hospital

Status

Unknown

Conditions

Esophageal Atresia

Treatments

Device: Pediatric endoscopic ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT04259528
IRB-P00032913

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

1 month to 21 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Patients with esophageal stricture following surgical repair
Experimental group
Description:
Patients with esophageal atresia following surgical repair who developed an esophageal stricture
Treatment:
Device: Pediatric endoscopic ultrasound

Trial contacts and locations

0

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Central trial contact

osama baghdadi, MBBS

Data sourced from clinicaltrials.gov

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