Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair

Esophageal Atresia Clinical Trial

Official title:

Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04259528
• Other study ID #: IRB-P00032913
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: March 2020
• Source: Boston Children’s Hospital
• Contact: osama baghdadi, MBBS
• Phone: 6173556058
• Email: osama.baghdadi[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Atresia

Intervention

Device:
• Pediatric endoscopic ultrasound
endoscopic ultrasound at the esophageal stricture site to assess echo texture and esophageal layers

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

References & Publications (4)

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. Review. — View 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. Epub 2006 Oct 17. — View 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. — View 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, Includin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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