Clinical trial NCT04259528: Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair
Official title: Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Atresia
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Predict post surgical primary repair outcome in patients with esophageal atresia using endoscopic ultrasound
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Boston Children's Hospital
name: michael manfredi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.