Primary Posterior Tracheopexy Prevents Tracheal Collapse

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

Interventions

OTHER

Randomisation between the PPT- and no-PPT-group

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

PROCEDURE

Primary Posterior Tracheopexy

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

DIAGNOSTIC_TEST

Preoperative tracheobronchoscopy

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.

DIAGNOSTIC_TEST

Intraoperative tracheobronchoscopy

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.

DIAGNOSTIC_TEST

Postoperative tracheobronchoscopy through the endotracheal tube during extubation

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.

DIAGNOSTIC_TEST

Postoperative tracheobronchoscopy after 2-6 months

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.

Sponsors & Collaborators

• Erasmus Medical Center

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• Great Ormond Street Hospital for Children NHS Foundation Trust

  collaborator OTHER

• For Wis(h)dom Foundation (funding)

  collaborator UNKNOWN

• UMC Utrecht

  lead OTHER

Principal Investigators

• John Vlot, MD, PhD · Erasmus Medical Center

• Jan F Svensson, MD, PhD · Karolinska University Hospital

• Colin Butler, MD, PhD · Great Ormond Street Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

34 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-01

Primary Completion

2027-03-01

Completion

2027-09-01

Countries

• Netherlands
• United Kingdom

Study Locations