Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair

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.

Study Overview

• Status: Unknown
• Conditions: Esophageal Atresia
• Intervention / Treatment: Device: Pediatric endoscopic ultrasound

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: osama baghdadi, MBBS; Phone Number: 6173556058; Email: osama.baghdadi@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients with esophageal stricture following surgical repair; Patients with esophageal atresia following surgical repair who developed an esophageal stricture	Device: Pediatric endoscopic ultrasound; endoscopic ultrasound at the esophageal stricture site to assess echo texture and esophageal layers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: michael manfredi, MD, Boston Children's Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2020
• Primary Completion (ANTICIPATED): July 30, 2021
• Study Completion (ANTICIPATED): July 30, 2021

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (ACTUAL): February 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 5, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Gastrointestinal Diseases; Esophageal Diseases; Digestive System Abnormalities; Esophageal Atresia
• Other Study ID Numbers: IRB-P00032913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No