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Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair

Primary Purpose

Esophageal Atresia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pediatric endoscopic ultrasound
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Esophageal Atresia

Eligibility Criteria

1 Month - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Patients with esophageal stricture following surgical repair

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    January 16, 2020
    Last Updated
    March 4, 2020
    Sponsor
    Boston Children's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04259528
    Brief Title
    Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair
    Official Title
    Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2020 (Anticipated)
    Primary Completion Date
    July 30, 2021 (Anticipated)
    Study Completion Date
    July 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Boston Children's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Atresia

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with esophageal stricture following surgical repair
    Arm Type
    Experimental
    Arm Description
    Patients with esophageal atresia following surgical repair who developed an esophageal stricture
    Intervention Type
    Device
    Intervention Name(s)
    Pediatric endoscopic ultrasound
    Intervention Description
    endoscopic ultrasound at the esophageal stricture site to assess echo texture and esophageal layers
    Primary Outcome Measure Information:
    Title
    Predict post surgical primary repair outcome in patients with esophageal atresia using endoscopic ultrasound
    Description
    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
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    osama baghdadi, MBBS
    Phone
    6173556058
    Email
    osama.baghdadi@childrens.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    michael manfredi, MD
    Organizational Affiliation
    Boston Children's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    12037771
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12677567
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28611969
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    17043852
    Citation
    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.
    Results Reference
    result

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    Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair

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