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Anomalies of Pulmonary Artery, CongenitalNCT04383184

Relationship Between Tracheal and Left Pulmonary Artery Stenosis Index and Prognosis of PA Sling With Tracheal Stenosis

An observational study of Anomalies of Pulmonary Artery, Congenital, run by Children's Hospital of Fudan University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pulmonary artery sling is a rare congenital pulmonary vascular malformation, often associated with tracheal or bronchial stenosis. Surgical treatment of pulmonary artery sling with tracheal stenosis has a high risk and a relatively poor prognosis. Read more about this study

Who is it for?
Ages 1 month to 57 months
What is being tested?
tracheoplasty
Type of treatment
Surgery or procedure
How many people
30 participants
Where
1 siteChina
Study dates
1 Jan 2010to 30 Dec 2018
Phase
Observational
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 57 months
  • All sexes
  • No healthy volunteers
  • Child

Study population: patients with tracheoplasty and left pulmonary artery transplantation at the same time, and only with left pulmonary artery transplantation

Inclusion Criteria: surgical cases of pulmonary artery sling operated in our center from January 2010 to December 2018 -

Exclusion Criteria:cases of pulmonary artery sling without opertion

-

Trial locations and contacts

1 site in 1 country.

China1 site
  • Children's Hospital of Fudan University

    Shanghai, Shanghai Municipality, 201102

Other trials in China

About this study

Official title: Relationship Between Tracheal and Left Pulmonary Artery Stenosis Index and Prognosis of Pulmonary Artery Sling With Tracheal Stenosis

Pulmonary artery sling is a rare congenital pulmonary vascular malformation, often associated with tracheal or bronchial stenosis. Surgical treatment of pulmonary artery sling with tracheal stenosis has a high risk and a relatively poor prognosis. This article aims to explore the relationship between the index of tracheal and left pulmonary artery stenosis and the surgical effect of pulmonary artery sling with tracheal stenosis. Methods: Retrospective analysis of the cases of pulmonary artery sling surgery in our center from January 2010 to December 2018. Before operation, routine cardiac enhancement CT examination was performed, and the diameter of the left pulmonary artery and the tracheal stenosis were measured on the CT tomogram respectively, and the ratio of the degree of tracheal stenosis / left pulmonary artery stenosis (T / P) was calculated, combining the surgical method and clinical prognosis analyzed and discussed.

Read the detailed description

Pulmonary artery sling is a rare congenital pulmonary vascular malformation. The abnormality of the left pulmonary artery originates from the right pulmonary artery instead of the trunk of the pulmonary artery. It passes around the trachea, passes between the trachea and the esophagus, and forms a vascular ring with the arterial ligament. Compression of the trachea and esophagus, especially the symptoms of tracheal stenosis caused by the compression of the trachea, can be manifested as serious symptoms such as respiratory infections, wheezing, and even respiratory distress, which can be life-threatening in severe cases. Therefore, the key to the surgical treatment of pulmonary artery sling is to relieve tracheal compression and correct tracheal stenosis, which is also the difficulty. At present, the overall survival rate of surgical treatment of pulmonary artery sling around the world is about 78% to 93% [1], but the mortality rate for patients with severe tracheal stenosis is also high, reaching about 24% [1], mainly due to pre-operative or post-operative respiratory failure caused by narrowed trachea. At present, the selection and intervention of pulmonary artery sling combined with tracheal stenosis is still a difficult problem. On the one hand, if tracheoplasty is performed, anastomotic scar hyperplasia after surgery may lead to local tracheal stenosis again [2], and long-term care is also quite difficult; If tracheoplasty is not performed, tracheal stenosis may not be completely relieved, and obstructive ventilation disorder and respiratory failure may occur after surgery [1]. At present, there is basically no objection to the preoperative assessment methods of pulmonary artery sling. CCTA is generally considered to be an effective method for diagnosing pulmonary artery sling with tracheal stenosis. It can display abnormally deformed pulmonary arteries and narrowed trachea, and it can also detect intracardiac malformations. The important means of preoperative evaluation can also be used for postoperative evaluation [3].

There is currently no consensus on the indications for tracheal intervention with pulmonary artery sling combined with tracheal stenosis. Some researchers believe that tracheoplasty should be performed for tracheal diameters less than 3mm, or the prognosis is poor [4]. Some researchers have suggested that the diameter / length percentage of tracheal stenosis can be used as a reference index for intervention of tracheal stenosis [5]. Brouns et al. found that the square of the cross-sectional area of the tracheal stenosis has a significant proportional relationship with the air flow, so they believe that the cross-sectional area of the tracheal stenosis is the main factor affecting the ventilation effect [6]. When I reviewed the imaging data of children with tracheal stenosis in our center, the most severe tracheal stenosis is usually located in the vascular ring formed by the right pulmonary artery starting segment, the left pulmonary artery starting segment, and the left pulmonary artery bypass segment. Not only was the trachea compressed and significantly narrowed, but the left pulmonary artery was also significantly narrowed, that is, the trachea and the left pulmonary artery were squeezed together in a limited space, causing both of them to be compressed and narrowed. This study was the first to investigate the interaction and morphological changes of the trachea and the left pulmonary artery, and the ratio of the degree of tracheal stenosis / left pulmonary artery stenosis (T / P) was used to indicate the degree of interaction between the two. A larger T / P ratio indicates that the left pulmonary artery is more dominant in tracheal compression, and tracheal stenosis is usually more serious. On the contrary, a smaller T / P ratio indicates that the trachea is more dominant in compression of the left pulmonary artery, and the tracheal stenosis is usually relatively lighter. This article retrospectively analyzes the cases in our center and discusses the effects of surgical treatment.

Being tested
tracheoplasty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tracheoplastyProcedure or surgery

    tracheoplasty and only left pulmonary artery transplantation

Study groups in NCT04383184
Study groupRoleWhat they receive
TRACHEAL FORMING GROUPLeft pulmonary artery transplantation and slide tracheoplasty
Receives: Procedure: tracheoplasty
NON-TRACHEAL FORMING GROUPonly Left pulmonary artery transplantation
Receives: Procedure: tracheoplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of tracheal forming group and non-tracheal forming group

    Tracheal stenosis (T) and left pulmonary artery stenosis (P) ratio were compared between the two groups

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2020
  2. Study start1 Jan 2010
  3. Primary completion30 Dec 2018
  4. Study completion30 Dec 2018

Resources

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
Retrospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04383184
Sponsor's protocol ID
2020(40)
Status last verified
May 2020
First submitted
7 May 2020
Last updated
12 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Anomalies of Pulmonary Artery, Congenital, run by Children's Hospital of Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 12 May 2020. 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of tracheal forming group and non-tracheal forming group (time frame: 30 days). 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 12 May 2020.

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