Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair

Sponsor
Boston Children's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04259528
Collaborator
(none)
50
1
17

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Pediatric endoscopic ultrasound
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair
Anticipated Study Start Date :
Mar 1, 2020
Anticipated Primary Completion Date :
Jul 30, 2021
Anticipated Study Completion Date :
Jul 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Boston Children's Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Michael A. Manfredi, MD, Medical Director of Esophageal and Airway Treatment Center, Assistent Professor of Pediatrics, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT04259528
Other Study ID Numbers:
  • IRB-P00032913
First Posted:
Feb 6, 2020
Last Update Posted:
Mar 5, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 5, 2020