Esophageal AtresiaNCT04259528
Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair
A study testing Pediatric endoscopic ultrasound in people with Esophageal Atresia, run by Boston Children's Hospital.
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. Read more about this study
- Who is it for?
- Ages 1 month to 21 years
- Conditions the study is for
- Esophageal Atresia
- What is being tested?
- Pediatric endoscopic ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Pediatric endoscopic ultrasound
- Medical subject headings
- Esophageal Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric endoscopic ultrasoundDevice
endoscopic ultrasound at the esophageal stricture site to assess echo texture and esophageal layers
| Study group | Role | What they receive |
|---|---|---|
| Patients with esophageal stricture following surgical repair | Experimental | Patients with esophageal atresia following surgical repair who developed an esophageal stricture Receives: Device: Pediatric endoscopic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Esophageal AtresiaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael A. Manfredi, MD, Boston Children's Hospital
- Investigators
- michael manfredi, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259528
- Sponsor's protocol ID
- IRB-P00032913
- Status last verified
- Mar 2020
- First submitted
- 16 Jan 2020
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12037771Amae 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.
PubMed 12677567Tambucci 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.
PubMed 28611969Khan 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.
PubMed 17043852
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair
- ClinicalTrials.gov ID
- NCT04259528
- Acronym / sponsor ID
- IRB-P00032913
- Conditions
- Esophageal Atresia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with esophageal stricture following surgical repair | Experimental | Device: Pediatric endoscopic ultrasoundPatients with esophageal atresia following surgical repair who developed an esophageal stricture |
Who may qualify
- Ages
- 1 month to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pediatric endoscopic ultrasoundendoscopic ultrasound at the esophageal stricture site to assess echo texture and esophageal layers | Device | Patients with esophageal stricture following surgical repair |
Primary outcome
Predict post surgical primary repair outcome in patients with esophageal atresia using endoscopic ultrasound
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Background: PubMed 12037771Kouchi 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.
- Background: PubMed 12677567Amae 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 publication: PubMed 28611969Tambucci 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 publication: PubMed 17043852Khan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
michael manfredi, MD principal investigator
Boston Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric endoscopic ultrasound in people with Esophageal Atresia, run by Boston Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact osama baghdadi, MBBS (6173556058, osama.baghdadi@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predict post surgical primary repair outcome in patients with esophageal atresia using endoscopic ultrasound (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04259528, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.