Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair

NCT04259528 | Unknown

• 1 other identifier: IRB-P00032913
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophageal Atresia

Outcome Measures

Primary Outcomes (1)

• Predict post surgical primary repair outcome in patients with esophageal atresia using endoscopic ultrasound

  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

  2 years

Study Arms (1)

Patients with esophageal stricture following surgical repair

EXPERIMENTAL

Patients with esophageal atresia following surgical repair who developed an esophageal stricture

Device: Pediatric endoscopic ultrasound

Interventions

Pediatric endoscopic ultrasound DEVICE

endoscopic ultrasound at the esophageal stricture site to assess echo texture and esophageal layers

Patients with esophageal stricture following surgical repair

Eligibility Criteria

• Age: 1 Month - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Related Publications (4)

• Kouchi K, Yoshida H, Matsunaga T, Ohtsuka Y, Nagatake E, Satoh Y, Terui K, Mitsunaga T, Ochiai T, Arima M, Ohnuma N. Endosonographic evaluation in two children with esophageal stenosis. J Pediatr Surg. 2002 Jun;37(6):934-6. doi: 10.1053/jpsu.2002.32921.

  PMID: 12037771 BACKGROUND

• Amae S, Nio M, Kamiyama T, Ishii T, Yoshida S, Hayashi Y, Ohi R. Clinical characteristics and management of congenital esophageal stenosis: a report on 14 cases. J Pediatr Surg. 2003 Apr;38(4):565-70. doi: 10.1053/jpsu.2003.50123.

  PMID: 12677567 BACKGROUND

• Tambucci R, Angelino G, De Angelis P, Torroni F, Caldaro T, Balassone V, Contini AC, Romeo E, Rea F, Faraci S, Federici di Abriola G, Dall'Oglio L. Anastomotic Strictures after Esophageal Atresia Repair: Incidence, Investigations, and Management, Including Treatment of Refractory and Recurrent Strictures. Front Pediatr. 2017 May 29;5:120. doi: 10.3389/fped.2017.00120. eCollection 2017.

  PMID: 28611969 RESULT

• Khan KM, Foker JE. Use of high-resolution endoscopic ultrasonography to examine the effect of tension on the esophagus during primary repair of long-gap esophageal atresia. Pediatr Radiol. 2007 Jan;37(1):41-5. doi: 10.1007/s00247-006-0333-9. Epub 2006 Oct 17.

  PMID: 17043852 RESULT

MeSH Terms

Conditions

Esophageal Atresia

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• michael manfredi, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

osama baghdadi, MBBS

CONTACT

6173556058; osama.baghdadi@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Esophageal and Airway Treatment Center, Assistent Professor of Pediatrics

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: February 6, 2020
• Study Start: March 1, 2020
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: March 5, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share