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.
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
- Conditions the study is for
- Anomalies of Pulmonary Artery, Congenital
- 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
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 group | Role | What they receive |
|---|---|---|
| TRACHEAL FORMING GROUP | Left pulmonary artery transplantation and slide tracheoplasty Receives: Procedure: tracheoplasty | |
| NON-TRACHEAL FORMING GROUP | only Left pulmonary artery transplantation Receives: Procedure: tracheoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted12 May 2020
- Study start1 Jan 2010
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anomalies of Pulmonary Artery, CongenitalStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Tracheal and Left Pulmonary Artery Stenosis Index and Prognosis of Pulmonary Artery Sling With Tracheal Stenosis
- ClinicalTrials.gov ID
- NCT04383184
- Acronym / sponsor ID
- 2020(40)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 12 May 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRACHEAL FORMING GROUP | – | Procedure: tracheoplastyLeft pulmonary artery transplantation and slide tracheoplasty |
| NON-TRACHEAL FORMING GROUP | – | Procedure: tracheoplastyonly Left pulmonary artery transplantation |
Who may qualify
- Ages
- 1 month to 57 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patients with tracheoplasty and left pulmonary artery transplantation at the same time, and only with left pulmonary artery transplantation
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 |
|---|---|---|
| tracheoplastytracheoplasty and only left pulmonary artery transplantation | Procedure or surgery | NON-TRACHEAL FORMING GROUP, TRACHEAL FORMING GROUP |
Primary outcome
Comparison of tracheal forming group and non-tracheal forming group
Time frame: 30 days
Tracheal stenosis (T) and left pulmonary artery stenosis (P) ratio were compared between the two groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 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.