A Prospective,randomized,controlled Clinical Trial Of Interventional Bronchoscopy In The Treatment Of Benign Central Airway Stenosis

Central airway stenosis is defined as the narrowing of the lumen of the trachea,right and left main bronchus,and right middle segment bronchus.Its pathogenesis is complicated,and can be divided into benign and malignant diseases.Patients with central airway stenosis often manifested as cough,expectoration,shortness of breath,dyspnea and stridor sound can be heard on physical examination,with lower respiratory tract infection can be moist rales heard.In China,the main pathogenic factor of benign airway stenosis is endobronchial tuberculosis,followed by tracheal stenosis caused by tracheal intubation and tracheotomy.Central airway stenosis seriously affects the quality of life of patients,threatening the lives of patients,and the high risk of surgical treatment.Therefore,it is recognized as a big problem worldwide.In recent years,many important advances have been made in the treatment of central airway stenosis by bronchoscopic interventional techniques.These techniques also received the unanimous recognition of the majority of medical workers and patients.However,there is no unified standard for these intervention methods.Different intervention methods have their own advantages and disadvantages for the same kind of disease,but which is better?Therefore,we have access to the relevant literature,and designed the randomized controlled clinical study,which divided into four groups,simple balloon dilation,balloon dilatation combined with cryotherapy,balloon dilation combined with needle knife,balloon dilatation combined with local injection of mitomycin C,to evaluate the efficacy and safety of various methods.Part1 A prospective,randomized,controlled clinical trial of interventional bronchoscopy in the treatment of tuberculous scar central airway stenosis ObjectiveFour different methods of interventional therapy were respectively given to the patients with tracheobronchial stenosis due to endobronchial tuberculosis.To analyze the safety and effectiveness of interventional techniques for the treatment of central airway stenosis caused by tuberculosis in our country and explore the best treatment for this kind of patients.Methods85 patients with tuberculous cicatricial central airway stenosis were randomly divided into four groups:A group using only balloon dilation;group B balloon dilation and freezing;group C using balloon dilation and topical application of mitomycin;D group with balloon dilation and needle-shaped electric knife.Each patient was treated with interventional therapy once a week for 4 weeks,and the efficacy was evaluated at fifth,9,13,21,25,and 29 weeks.Evaluation index: dyspnea score,KPS,degree of stenosis,length of stenosis,efficiency,and clinical yields.Results1.Analysis of the location and degree of stenosis of central airway stenosis: tracheal stenosis in 14 cases(16.47%),left main bronchial stenosis in 37 cases(43.53%),right main bronchial stenosis in 26 cases(30.59%),right middle segment tracheal stenosis in 8 cases(9.41%);Stenosis degree:Grade III stenosis in 9 cases(10.59%),Grade ? stenosis in50 cases(58.82%),Grade V stenosis in 26 cases(30.59%)?There was no significant difference between the four groups in the stenosis site and the degree of stenosis(P>0.05).2.The improvement of dyspnea score and KPS score,the degree of stenosis after treatment: Compared with before treatment,the dyspnea score,KPS and the degree of stenosis was significantly improved in all patients after treatment and had statistical significance(all P<0.05).The dyspnea score from before treatment(2.19±0.55)points to decrease(0.89 ±0.53)points after treatment,KPS score before treatment is(40.94 ±8.26)points to increase(92.59 ± 5.15)points after treatment,and the degree of stenosis before treatment(80.82±9.07)to decrease(22.06±9.28)after treatment,no significant differences between groups.3.Therapeutic evaluation: After bronchoscopic interventional therapy,the dyspnea score,KPS was significantly improved.In addition to group B had a lower efficiency(82.4%),the remaining three groups of patients with efficiency and clinical yields were above 90%.There was no significant difference between the two groups(P > 0.05)4.Adverse event reporting and analysis: There were no serious adverse reactions in the course of interventional therapy,such as massive hemoptysis,pneumothorax,bronchospasm and so on.There were 8 cases of mild bleeding,local injection of freeze-dried blood clotting enzyme stop bleeding.3 cases of chest pain,no special treatment for relief.2 patients was induced airway mucosa tear,ease in oxygen treatment and have a rest,without special treatment.The trial was dropped of 7 patients,who were not willing to follow up for personal reasons.ConclusionThe above methods can be effective in the treatment of tuberculous scar stenosis,there is no statistical significance between the four groups in curative effects(P > 0.05).In order to simplify the treatment program and lower the cost of treatment,we recommend the use of balloon dilatation alone among the four methods mentioned above.Part 2.A prospective,randomized,controlled clinical trial of interventional bronchoscopy in the treatment of central airway stenosis after tracheal intubation or tracheotomy ObjectiveFour different methods of interventional therapy were respectively given to the patients with airway stenosis caused by tracheal intubation or tracheotomy.To analyze the safety and effectiveness of interventional techniques for the treatment of central airway stenosis caused by tracheal intubation or tracheotomy in our country and explore the best treatment for this kind of patients.Methods78 patients with central airway stenosis caused by tracheal intubation and tracheotomy were randomly divided into four groups.A group using only balloon dilation;group B using balloon dilation and freezing;group C balloon dilation and topical application of mitomycin;group D with balloon dilation and needle-shaped electric knife.Each patient was treated with bronchoscopic interventional therapy once a week for 4 weeks,and the efficacy was evaluated at fifth,9,13,21,25,and 29 weeks.The evaluation indexes are as follows: dyspnea score,KPS,degree of stenosis,length of stenosis,efficiency,and clinical yields.Results1.Analysis of the location and degree of stenosis of central airway stenosis: Upper tracheal stenosis in 36 cases(45.57%),middle tracheal stenosis in 43 cases(54.43%);Stenosis degree:Grade III stenosis in 22 cases(27.85%),Grade ? stenosis in 43 cases(54.43%),Grade V stenosis in 14 cases(17.72%)?There was no significant difference between the four groups in the stenosis site and the degree of stenosis(P>0.05).2.The improvement of dyspnea score and KPS score,the degree of stenosis after treatment: Compared with before treatment,the dyspnea score,KPS and the degree of stenosis was significantly improved in all patients after treatment and had statistical significance(all P<0.05).The dyspnea score from before treatment(2.23±0.35)points to decrease(0.82 ±0.38)points after treatment,KPS score before treatment is(39.83 ± 6.75)points to increase(90.58±8.12)points after treatment,and the degree of stenosis before treatment(81.69±7.06)to decrease(20.39±7.20)after treatment,no significant differences between groups(P>0.05).3.Therapeutic evaluation: All the patients were followed up regularly,and the efficiency and clinical benefit rate of the four groups were above 85% after the interventional treatment of bronchoscopic techniques.There was no significant difference between the two groups(P > 0.05).For the first time,the cross-sectional area of the stenosis was the largest,followed by the phenomenon of partial retraction of the lumen,but it was still significantly expanded before treatment,and the patency of the lumen was more than half a year.4.Adverse event reporting and analysis: There were 9 cases of intraoperative bleeding,bleeding volume greater than 10 ml,local injection of epinephrine and thrombin to stop bleeding.There were 7 cases of hypoxemia,ceased the operation and used nasal catheter oxygen inhalation,soon relieved.5 cases of chest pain,no special treatment for relief.2 patients was induced airway mucosa mild tear,ease in oxygen and rest,without special treatment.ConclusionThese four methods are effective in the treatment of central airway stenosis caused by tracheal intubation and tracheotomy.Patients with good tolerability,small trauma and high safety,and the effects are obvious.There was no significant difference between the four groups by statistical analysis(P > 0.05).In order to simplify treatment procedure and save treatment costs,we recommend the use of balloon dilatation independently among the four methods mentioned above.