Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair

NCT ID: NCT04259528

Last Updated: 2020-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-07-30

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.

Conditions

Esophageal Atresia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with esophageal stricture following surgical repair

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

Group Type: EXPERIMENTAL

Pediatric endoscopic ultrasound

Intervention Type: DEVICE

endoscopic ultrasound at the esophageal stricture site to assess echo texture and esophageal layers

Interventions

Pediatric endoscopic ultrasound

endoscopic ultrasound at the esophageal stricture site to assess echo texture and esophageal layers

Intervention Type: DEVICE

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Michael A. Manfredi, MD

Medical Director of Esophageal and Airway Treatment Center, Assistent Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

michael manfredi, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Central Contacts

osama baghdadi, MBBS

Role: CONTACT

osama.baghdadi@childrens.harvard.edu

6173556058

References

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.

Reference Type: BACKGROUND

PMID: 12037771 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12677567 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28611969 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17043852 (View on PubMed)

Other Identifiers

IRB-P00032913

Identifier Type: -

Identifier Source: org_study_id