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Platelet-rich plasma(PRP), is a concentrate of platelet-rich plasma protein derived from whole blood. The main components of it are platelets, leukocytes and fibrin. Autologous PRP treatment can avoid the immune rejection caused by exogenous growth factor and the spread of disease. Evidence of the efficacy and safety of PRP has been proven in many studies. Benign central airway stenosis is characterized by airway compromise involving the larynx, trachea, or bronchi and will lead to devastating consequences. Unfortunately, the incidence of this disease is increasing steadily. As most important treatment for benign airway stenosis, respiratory intervention has become one of the most common treatments to fight the disease. However, the restenosis caused by tissue hyperplasia, wound repair and scar formation after treatment is still common, which remains the limitation of respiratory intervention. Long-term efficacy of repeated interventional treatment is unsatisfying, too. Several studies have discovered similar mechanism between stenosis of tracheal to hyperplastic scar of skin, both of which are relative with deep structure injury such as the intrinsic layer of airway mucosa. PRP has shown significant efficacy for hyperplastic scar of skin. Correspondingly, PRP will be applied as treatment of refractory benign airway stenosis to reduce restenosis by inhibit the formation of granulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Procedure/Surgery: Conventional therapy of airway stenosis is including, but not limited to: laser, high frequency electric knife, argon plasma coagulation (APC), cryotherapy, balloon dilation and metal stent placement |
|
| PRP group | Experimental | Procedure/Surgery: PRP PRP treatment following the conventional treatment Slow spray / inject autogenous PRP to cover the wound of stenosis. Procedure/Surgery: Conventional therapy of airway stenosis is including, but not limited to: laser, high frequency electric knife, argon plasma coagulation (APC), cryotherapy, balloon dilation and metal stent placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP | Procedure | PRP treatment following the conventional treatment for benign airway stenosis which contain a concentrate of platelet-rich plasma protein derived from whole blood. |
| Measure | Description | Time Frame |
|---|---|---|
| Cure rate for benign stenosis | Proportion of patients who is no need for endotracheal intervention and with stable clinical symptoms after PRP treatment | within 6 months after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission time | The interval time of the first intratracheal interventional therapy needed again after 6 times of PRP treatment | 6 months after administration |
| Times of unplanned treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiyue Li, MD | Contact | 86-020-83062885 | lishiyue@188.com | |
| Xiaobo Chen, MD | Contact | 86-020-83062885 | xiaobo-win@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shiyue Li, MD | Guangzhou Institute of Respiratory Disease | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510120 | China |
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| Conventional treatment for benign airway stenosis | Procedure | Including, but not limited to: laser, high frequency electric knife, argon plasma coagulation (APC), cryotherapy, balloon dilation and metal stent placement |
|
The number of times a patient needs to be reviewed and treated by bronchoscopy for cough, expectoration and dyspnea
| within 6 months after administration |
| Incidence of complications associated with PRP treatment | Wound healing, sputum retention, etc. during follow-up | within 6 months after administration |