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
About this trial
This is an interventional diagnostic trial for Esophageal Atresia
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
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
NCT ID
NCT04259528
First Posted
January 16, 2020
Last Updated
March 4, 2020
Sponsor
Boston Children's Hospital
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
Learn more about this trial
Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair
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