Primary Posterior Tracheopexy Prevents Tracheal Collapse

NCT06335862 | Enrolling By Invitation DMC

• 1 other identifier: NL.84862.041.23
• Study Type: interventional
• Target: 78
• Locations: 2 countries
• Sites: 3

Brief Summary

Introduction: Children born with a blind-ending gullet (oesophagus), or Oesophageal Atresia (OA), need to undergo surgical correction in the first week of life. OA is often accompanied by a weakened windpipe (trachea), known as tracheomalacia (TM). TM entails that the windpipe collapses during expiration. Severe TM can cause respiratory symptoms, including frequent respiratory tract infections and blue spells, that can potentially lead to life-threatening events. In some patients, major secondary surgical treatment may be indicated. This surgical procedure involves widening the trachea (using sutures) to prevent collapse, known as secondary posterior tracheopexy (SPT). Prior to performing this SPT, complications and negative consequences of TM may have already occurred. This may be prevented by performing this procedure during the primary OA correction, called a primary posterior tracheopexy (PPT). The aim of this trial is to determine if a PPT can decrease - or prevent - tracheal collapse in newborns with OA and TM, compared to a wait-and-see policy (no-PPT). Methods: This is an international multicentre double-blind randomised controlled trial. Seventy eight children with OA type C will be included. Patients will be included after written parental informed consent. Half of the patients will be randomly allocated to the PPT-group and half to the no-PPT-group. The degree and location of TM are evaluated through preoperative, intraoperative and two postoperative videoscopic examinations of the trachea (tracheobronchoscopy). Whether TM symptoms occur is assessed during three routine follow-up consultations until the age of 6 months. The primary outcome is the degree of collapse of the tracheal wall during the intraoperative tracheobronchoscopy (after performing the PPT/no-PPT), measured in percentages. Risks and burden: Since OA correction with PPT (more recently implemented in centres of expertise) and without PPT (wait-and-see policy) are both accepted and safe treatment options, participating in the trial does not pose an increased risk or burden with regards to the treatment. Performing tracheobronchoscopies may pose a potential burden. However, a tracheobronchoscopy is a routine diagnostic procedure commonly used to safely assess the trachea. Complications of a tracheobronchoscopy are rare. Also, many of the tracheobronchoscopies are routinely performed as part of standard care for these patients, regardless of the trial.

Conditions

Oesophageal Atresia With Tracheo-Oesophageal Fistula; Tracheomalacia; Oesophageal Atresia

Keywords

Oesophageal atresia; Tracheomalacia; Primary Posterior Tracheopexy; Respiratory Morbidity

Outcome Measures

Primary Outcomes (1)

• Difference in degree of TM between the PPT-group and no-PPT-group during intraoperative tracheobronchoscopy

  The difference in the degree of tracheal collapse between the PPT and the no-PPT group measured in percentage of the tracheal diameter

  Measured by an intraoperative tracheobronchoscopy performed after freeing the trachea and oesophagus (and the PPT) but before the surgical correction of OA, through the ventilation tube

Secondary Outcomes (3)

• Key secondary outcome: Difference in degree of TM between the PPT-group and no-PPT-group during postoperative tracheobronchoscopy

  Measured by a tracheobronchoscopy performed during extubation (approximately 1 day after surgery) and by a tracheobronchoscopy 2-6 months after surgery.

• Difference in symptoms between the PPT-group and no-PPT-group

  During follow-up, starting at the first follow-up consultation at 2-3 months, until the last follow-up consultation at 6 months.

• Degree of preoperative TM compared to postoperative TM

  Comparison between the measurements during the preoperative tracheobronchoscopy and the postoperative tracheobronchoscopy at 2-6 months postoperative.

Study Arms (2)

PPT-group

OTHER

Participants allocated to this study arm will undergo the primary posterior tracheopexy (PPT). This PPT is performed concurrently with the primary OA correction. Afterwards, all patients follow the (same) routine follow-up schedule. This treatment is currently used in some centres.

Other: Randomisation between the PPT- and no-PPT-group; Procedure: Primary Posterior Tracheopexy; Diagnostic Test: Preoperative tracheobronchoscopy; Diagnostic Test: Intraoperative tracheobronchoscopy; Diagnostic Test: Postoperative tracheobronchoscopy through the endotracheal tube during extubation; Diagnostic Test: Postoperative tracheobronchoscopy after 2-6 months

No-PPT-group

OTHER

Participants allocated to this study arm will undergo the the primary OA correction, without a PPT. Afterwards, all patients follow the (same) routine follow-up schedule. This treatment is also used in some centres.

Other: Randomisation between the PPT- and no-PPT-group; Diagnostic Test: Preoperative tracheobronchoscopy; Diagnostic Test: Intraoperative tracheobronchoscopy; Diagnostic Test: Postoperative tracheobronchoscopy through the endotracheal tube during extubation; Diagnostic Test: Postoperative tracheobronchoscopy after 2-6 months

Interventions

Randomisation between the PPT- and no-PPT-group OTHER

Randomisation is performed between two possible treatment options for tracheomalacia in OA patients; the PPT or the wait-and-see policy (no-PPT).

No-PPT-group; PPT-group

Primary Posterior Tracheopexy PROCEDURE

The PPT involves fixating the posterior membrane of the trachea to the spinal ligament with sutures, to prevent the trachea from collapsing.

PPT-group

Preoperative tracheobronchoscopy DIAGNOSTIC_TEST

Prior to OA correction, a flexible and a rigid tracheobronchoscopy will be performed, in addition to a flexible tracheobronchoscopy through the endotracheal tube. Preoperative evaluation of TM through a tracheobronchoscopy is part of standard care for all participating centres.

No-PPT-group; PPT-group

Intraoperative tracheobronchoscopy DIAGNOSTIC_TEST

After the PPT is performed, or in case of the no-PPT group at the stage of the surgery when the PPT would usually be performed, a flexible tracheobronchoscopy through the endotracheal tube is carried out. This tracheobronchoscopy is routine care for all patients undergoing a PPT, and is additional for patients in the no-PPT-group.

No-PPT-group; PPT-group

Postoperative tracheobronchoscopy through the endotracheal tube during extubation DIAGNOSTIC_TEST

A postoperative flexible tracheobronchoscopy is performed in the neonatal or pediatric intensive care unit (ICU), through the endotracheal tube during extubation. This procedure is a study intervention.

No-PPT-group; PPT-group

Postoperative tracheobronchoscopy after 2-6 months DIAGNOSTIC_TEST

Two to six months after OA correction, a follow-up flexible and a rigid tracheobronchoscopy will be performed, under general anesthesia in the surgical theatre. This postoperative evaluation of TM through a tracheobronchoscopy is part of standard care for the Karolinska University Hospital and Great Ormond Street Hospital. At the University Medical Centre Utrecht and Erasmus Medical Centre Rotterdam, this tracheobronchoscopy is performed on indication in approximately half of patients. For the other half of patients, this is a study intervention.

No-PPT-group; PPT-group

Eligibility Criteria

• Age: 34 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a confirmed diagnosis of OA with a distal TOF
• Tracheomalacia
• Written informed consent by both parents or legal representatives

You may not qualify if:

• Patients with OA without a distal TOF
• Premature neonates \<34 weeks
• Endotracheal tube size \< 3.0
• Cormack score 3 or 4 as scored by either the otolaryngologist, anesthesiologist, or neonatal/pediatric intensive care specialist
• Patients with a cyanotic cor vitium

Sponsors & Collaborators

• UMC Utrecht: lead
• Erasmus Medical Center: collaborator
• Karolinska University Hospital: collaborator
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator
• For Wis(h)dom Foundation (funding): collaborator

Study Sites (3)

Erasmus Medical Center Rotterdam

Rotterdam, 3015GD, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Great Ormond Street Hospital

London, WC1N 3JH, United Kingdom

Location

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MeSH Terms

Conditions

Esophageal atresia with or without tracheoesophageal fistula; Tracheomalacia; Esophageal Atresia

Condition Hierarchy (Ancestors)

Tracheobronchomalacia; Cartilage Diseases; Musculoskeletal Diseases; Tracheal Diseases; Respiratory Tract Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Digestive System Abnormalities; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• John Vlot, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Jan F Svensson, MD, PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

• Colin Butler, MD, PhD

  Great Ormond Street Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All participants, parents/caregivers, investigators and treating healthcare personnel, except for the surgical team performing the OA correction, will be blinded to which study arm the participant is assigned. None of the data gathered is affected by the unblinded surgical team since the primary and key secondary outcome measures are evaluated based on pseudonymised video footage. Furthermore, this video footage is assessed by otolaryngologists who are blinded to the patient and study arm. Moreover, the follow-up and documentation of the secondary endpoints are typically performed by the paediatrician and speech- and language therapists (not the paediatric surgeon or otolaryngologist).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Patients will be randomized 1:1 into either the intervention group (PPT-group) or the wait-and-see group (no-PPT). Since the sutures of the PPT remain in place (in the PPT-group), the participants are allocated to one arm for the duration of the study. After the PPT was or was not performed, the participants will follow the same follow-up schedule.

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); NL (2)