Tracheoesophageal FistulaCBESBNCT07687628
Camera-based Endoscopy Allows Spontaneous Breathing Diagnostic Management in Neonates With Tracheoesophageal Fistula
An observational study of Tracheoesophageal Fistula and Esophageal Atresia With Tracheo-esophageal Fistula, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
Trial summary
The investigators aim to compare rigid tracheoscopy versus flexible tracheo-video-endoscopy in neonates requiring diagnostic assessment before undergoing a congenital tracheoesophageal fistula repair. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Tracheoesophageal Fistula, Esophageal Atresia With Tracheo-esophageal Fistula
- What is being tested?
- tracheoscopy performed with rigid optical tracheoscopy and flexible video endoscopy of trachea
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2024to 31 Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Consecutive neonates undergoing surgical repair of esophageal atresia with or without tracheoesophageal fistula at a single tertiary pediatric center (ASST Papa Giovanni XXIII, Bergamo, Italy). The retrospective cohort includes patients treated from January 2013; the prospective cohort includes patients enrolled from October 2024 onward.
Who may be able to join
- Neonates who have undergone surgical repair of esophageal atresia with or without tracheoesophageal fistula at ASST Papa Giovanni XXIII, Bergamo, from 1 January 2013 onwards
- Written informed consent signed by both parents or legal guardian
Who cannot join
- Refusal or inability to obtain informed consent from parents or legal guardian
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Sc Ricerca Clinica, Sviluppo E Innovazione
Bergamo, Italy, 24100
Monia Lorini, Director, +39-035-2673341/4432, mlorini@asst-pg23.it
About this study
The investigators aim to compare rigid tracheoscopy versus flexible tracheo-video-endoscopy in neonates requiring diagnostic assessment before undergoing a congenital tracheoesophageal fistula repair.
Read the detailed description
Tracheoesophageal fistula, with or without esophageal atresia, is a rare congenital malformation which may be included in a wider spectrum of congenital abnormalities (VACTERL: vertebral, anorectal, cardiac, tracheoesophageal, renal and limb abnormalities). This condition presents challenging airway management due to the risk of gastric distension during positive pressure ventilation. ERNICA guidelines suggest that a tracheoscopy should be routinely performed preoperatively to evaluate the fistula position, rule out a double fistula, and identify other tracheal pathology; however, the optimal setting and approach remains controversial. Rigid tracheoscopy, performed in paralyzed neonates, can provide superior visualization of the trachea, but with a risk of gastric distension; moreover, the learning curve is steep. Flexible tracheoscopy using conventional fiberoptic bronchoscopes could allow maintenance of spontaneous breathing, but image quality is poor. New-generation disposable video-endoscopes come equipped with a miniaturized camera that replaces traditional fiberoptic technology, enabling enhanced visualization. The goal of this observational ambispective study is to compare the outcomes of two different airway management approaches in neonates and infants undergoing congenital tracheoesophageal fistula repair: rigid tracheoscopy with flexible video-endoscopy. The main questions the investigators aim to answer are: Is the tracheal flexible video-endoscopy performed in spontaneously breathing neonates effective, regarding optimal tracheal visualization and therefore for accurate diagnosis? Does it allow the successful detection and eventually rigid wire cannulation of the fistula? Are there differences between the two approaches, regarding the procedure length, or the incidence of complications (desaturation, gastric distension, respiratory depression, major cardiopulmonary complications)? Do the two approaches differ in learning curve shape? The investigators will compare a historical cohort of neonates who underwent rigid tracheoscopy with positive pressure ventilation, with a prospective group of neonates that will receive spontaneous breathing flexible tracheoscopy.
- Being tested
- tracheoscopy performed with rigid optical tracheoscopy, flexible video endoscopy of trachea
- Keywords
- tracheoesophageal fistula
- Medical subject headings
- Tracheoesophageal Fistula, Esophageal atresia with or without tracheoesophageal fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tracheoscopy performed with rigid optical tracheoscopyProcedure or surgery
Rigid tracheoscopy is performed with rigid 3.0 or 3.5 mm optical device under general anesthesia and positive pressure ventilation
flexible video endoscopy of tracheaDevice
Flexible tracheoscopy is performed with Ambu 2.7 flexible video-endoscopy under sedation in spontaneously breathing neonates
| Study group | Role | What they receive |
|---|---|---|
| flexible video-endoscopy | Neonates undergoing surgical repair of tracheoesophageal fistula from October 2024 onwards, in whom preoperative airway assessment is performed by flexible video-endoscopy (Ambu aScope 5 Broncho 2.7/1.2) under deep sedation with maintenance of spontaneous breathing and topical anesthesia of the upper airways and vocal cords. Receives: Device: flexible video endoscopy of trachea | |
| rigid tracheoscopy | All neonates who underwent surgical repair of tracheoesophageal fistula from January 2013 to September 2024, plus neonates undergoing surgical repair of tracheoesophageal fistula from October 2024 onwards, in whom preoperative airway assessment was performed by rigid optical tracheoscopy under general anesthesia with positive pressure ventilation. Receives: Procedure: tracheoscopy performed with rigid optical tracheoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic success rate of preoperative tracheoscopy
Percentage of procedures in which the technique allowed correct visualization of the tracheoesophageal fistula, including identification of secondary fistulas, out of total procedures performed with each method (rigid vs flexible bronchoscopy)
Measured: Intraoperative (at the time of the preoperative tracheoscopy procedure)
Secondary outcomes (6)
Incidence of anesthetic complications
Rate of preoperative or intraoperative anesthetic complications (respiratory, cardiovascular) during tracheoscopy and surgical repair
Measured: Intraoperative
Learning curve of each tracheoscopy technique
Number of supervised procedures required before the operator achieved adequate autonomous proficiency with rigid vs flexible bronchoscopy
Measured: From the first procedure to the achievement of autonomous competence with each technique, assessed over the total study duration (up to 5 years)
Gastric distension
Presence of gastric distension (yes/no) at the beginning of the surgical phase
Measured: Perioperative (at initiation of the surgical procedure)
Arterial blood gas values at baseline
Arterial blood gas parameters (pH, PCO2, PO2, lactate, base excess) at baseline (prior to tracheoscopy)
Measured: Baseline (immediately before tracheoscopy)
Arterial blood gas values at beginning of surgery
Arterial blood gas parameters (pH, PCO2, PO2, lactate, base excess) at beginning of the surgical procedure
Measured: Perioperative (at initiation of the surgical procedure)
Arterial blood gas values at end of surgery
Description: Arterial blood gas parameters (pH, PCO2, PO2, lactate, base excess) at conclusion of the surgical procedure
Measured: At conclusion of the surgical procedure (up to 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Oct 2024
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheoesophageal FistulaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papa Giovanni XXIII Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Mariconti, Papa Giovanni XXIII Hospital
- Investigators
- Ezio Bonanomi, MD, Study chair, A.O. Ospedale Papa Giovanni XXIII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687628
- Sponsor's protocol ID
- VideoendoFTE
- Acronym
- CBESB
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camera-based Endoscopy Allows Spontaneous Breathing Diagnostic Management in Neonates With Tracheoesophageal Fistula
- ClinicalTrials.gov ID
- NCT07687628
- Acronym / sponsor ID
- CBESB / VideoendoFTE
- Keywords
- tracheoesophageal fistula
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Papa Giovanni XXIII HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 7 Jul 2026 (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.
The investigators aim to compare rigid tracheoscopy versus flexible tracheo-video-endoscopy in neonates requiring diagnostic assessment before undergoing a congenital tracheoesophageal fistula repair.
Detailed description
Tracheoesophageal fistula, with or without esophageal atresia, is a rare congenital malformation which may be included in a wider spectrum of congenital abnormalities (VACTERL: vertebral, anorectal, cardiac, tracheoesophageal, renal and limb abnormalities). This condition presents challenging airway management due to the risk of gastric distension during positive pressure ventilation. ERNICA guidelines suggest that a tracheoscopy should be routinely performed preoperatively to evaluate the fistula position, rule out a double fistula, and identify other tracheal pathology; however, the optimal setting and approach remains controversial. Rigid tracheoscopy, performed in paralyzed neonates, can provide superior visualization of the trachea, but with a risk of gastric distension; moreover, the learning curve is steep. Flexible tracheoscopy using conventional fiberoptic bronchoscopes could allow maintenance of spontaneous breathing, but image quality is poor. New-generation disposable video-endoscopes come equipped with a miniaturized camera that replaces traditional fiberoptic technology, enabling enhanced visualization. The goal of this observational ambispective study is to compare the outcomes of two different airway management approaches in neonates and infants undergoing congenital tracheoesophageal fistula repair: rigid tracheoscopy with flexible video-endoscopy. The main questions the investigators aim to answer are: Is the tracheal flexible video-endoscopy performed in spontaneously breathing neonates effective, regarding optimal tracheal visualization and therefore for accurate diagnosis? Does it allow the successful detection and eventually rigid wire cannulation of the fistula? Are there differences between the two approaches, regarding the procedure length, or the incidence of complications (desaturation, gastric distension, respiratory depression, major cardiopulmonary complications)? Do the two approaches differ in learning curve shape? The investigators will compare a historical cohort of neonates who underwent rigid tracheoscopy with positive pressure ventilation, with a prospective group of neonates that will receive spontaneous breathing flexible tracheoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flexible video-endoscopy | – | Device: flexible video endoscopy of tracheaNeonates undergoing surgical repair of tracheoesophageal fistula from October 2024 onwards, in whom preoperative airway assessment is performed by flexible video-endoscopy (Ambu aScope 5 Broncho 2.7/1.2) under deep sedation with maintenance of spontaneous breathing and topical anesthesia of the upper airways and vocal cords. |
| rigid tracheoscopy | – | Procedure: tracheoscopy performed with rigid optical tracheoscopyAll neonates who underwent surgical repair of tracheoesophageal fistula from January 2013 to September 2024, plus neonates undergoing surgical repair of tracheoesophageal fistula from October 2024 onwards, in whom preoperative airway assessment was performed by rigid optical tracheoscopy under general anesthesia with positive pressure ventilation. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Consecutive neonates undergoing surgical repair of esophageal atresia with or without tracheoesophageal fistula at a single tertiary pediatric center (ASST Papa Giovanni XXIII, Bergamo, Italy). The retrospective cohort includes patients treated from January 2013; the prospective cohort includes patients enrolled from October 2024 onward.
Key inclusion criteria (2 listed)
- Neonates who have undergone surgical repair of esophageal atresia with or without tracheoesophageal fistula at ASST Papa Giovanni XXIII, Bergamo, from 1 January 2013 onwards
- Written informed consent signed by both parents or legal guardian
Key exclusion criteria (1 listed)
- Refusal or inability to obtain informed consent from parents or legal guardian
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 |
|---|---|---|
| tracheoscopy performed with rigid optical tracheoscopyRigid tracheoscopy is performed with rigid 3.0 or 3.5 mm optical device under general anesthesia and positive pressure ventilation | Procedure or surgery | rigid tracheoscopy |
| flexible video endoscopy of tracheaFlexible tracheoscopy is performed with Ambu 2.7 flexible video-endoscopy under sedation in spontaneously breathing neonates | Device | flexible video-endoscopy |
Primary outcome
Diagnostic success rate of preoperative tracheoscopy
Time frame: Intraoperative (at the time of the preoperative tracheoscopy procedure)
Percentage of procedures in which the technique allowed correct visualization of the tracheoesophageal fistula, including identification of secondary fistulas, out of total procedures performed with each method (rigid vs flexible bronchoscopy)
6 secondary outcomes
Incidence of anesthetic complications
Time frame: Intraoperative
Learning curve of each tracheoscopy technique
Time frame: From the first procedure to the achievement of autonomous competence with each technique, assessed over the total study duration (up to 5 years)
Gastric distension
Time frame: Perioperative (at initiation of the surgical procedure)
Arterial blood gas values at baseline
Time frame: Baseline (immediately before tracheoscopy)
Arterial blood gas values at beginning of surgery
Time frame: Perioperative (at initiation of the surgical procedure)
Arterial blood gas values at end of surgery
Time frame: At conclusion of the surgical procedure (up to 30 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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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.
Ezio Bonanomi, MD study chair
A.O. Ospedale Papa Giovanni XXIII
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheoesophageal Fistula and Esophageal Atresia With Tracheo-esophageal Fistula, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Mariconti, MD (+39 035.267.5150/49, smariconti@asst-pg23.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic success rate of preoperative tracheoscopy (time frame: Intraoperative (at the time of the preoperative tracheoscopy procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2026.