Treatment of malignant airway obstruction with Y-shape sigma stent loaded with I125 seeds installed via rigid bronchoscopy.

PURPOSE: To summarize and analyze the safety and efficacy of a Y-shape Sigma stent loaded with I125 in patients with inoperable malignant main airway obstruction. METHODS: This study was approved by the Institutional Ethics Committee, and a written informed consent was obtained from each participant. A Y-shape Sigma stent loaded with I125 was placed under vision from rigid bronchoscopy. The primary endpoint was alleviation of symptoms and improvement of Karnofsky Performance Status (KPS) score, and the secondary endpoint was complications and technical success. RESULTS: From November 2018 through June 2023, total 33 patients with malignant airway obstruction were palliatively treated by installing Y-shape Sigma stents loaded with I125. The airway lumen was immediately restored and the average airway opening significantly increased to 70 ± 9.4% after the procedure from baseline 30.2 ± 10.5% (p < 0.05). Average KPS score was improved from baseline 30.0 ± 10.0 to 70.0 ± 10.0 (p < 0.05) as well as PaO2 from baseline 50.1 ± 15.4 mmHg to 89.3 ± 8.6 mmHg (p < 0.05). The technical success rate of placing the stent in this study was 73%, and adverse events or complications including bleeding, I125 loss, and airway infection occurred during or after the procedure. CONCLUSION: Placement of Y-shape Sigma stents under vision from rigid bronchoscopy in the patients with malignant airway obstruction is feasible and it immediately alleviates dyspnea and significantly improves quality of life.

Multi-institutional retrospective analysis of adverse events following rigid tracheobronchoscopy.

BACKGROUND AND OBJECTIVE: Rigid tracheobronchoscopy (RTB) has seen an increasing interest over the last decades with the development of the field of IPM but no benchmark exists for complication rates in RTB. We aimed to establish benchmarks for complication rates in RTB. METHODS: A multicentric retrospective analysis of RTB performed between 2009 and 2015 in eight participating centres was performed. RESULTS: A total of 1546 RTB were performed over the study period. One hundred and thirty-one non-lethal complications occurred in 103 procedures (6.7%, 95% CI: 5.5-8.0%). The periprocedural mortality rate was 1.2% (95% CI: 0.6-1.8%). The 30-day mortality rate was 5.6% (95% CI: 4.5-6.8%). Complication rate increases further when procedures were performed in an emergency setting. Procedures in patients with MAO are associated with a higher 30-day mortality (8.1% vs 2.7%, P < 0.01) and a different complication profile when compared to procedures performed for BAS. CONCLUSION: RTB is associated with a 6.7% non-lethal complication rate, a 1.2% periprocedural mortality rate and a 5.6% 30-day mortality in a large multicentre cohort of patients with benign and malignant airway disease.

Impact of Silicone Stent Placement in Symptomatic Airway Obstruction due to Non-Small Cell Lung Cancer - A French Multicenter Randomized Controlled Study: The SPOC Trial.

BACKGROUND: Therapeutic bronchoscopy (TB) is an accepted strategy for the symptomatic management of central airway malignant obstruction. Stent insertion is recommended in case of extrinsic compression, but its value in preventing airway re-obstruction after endobronchial treatment without extrinsic compression is unknown. OBJECTIVE: Silicone stent Placement in symptomatic airway Obstruction due to non-small cell lung Cancer (SPOC) is the first randomized controlled trial investigating the potential benefit of silicone stent insertion after successful TB in symptomatic malignant airway obstruction without extrinsic compression. METHOD: We planned an inclusion of 170 patients in each group (stent or no stent) over a period of 3 years with 1-year follow-up. The 1-year survival rate without symptomatic local recurrence was the main endpoint. Recurrence rate, survival, quality of life, and stent tolerance were secondary endpoints. During 1-year follow-up, clinical events were monitored by flexible bronchoscopies and were evaluated by an independent expert committee. RESULTS: Seventy-eight patients (mean age 65 years) were randomized into 2 arms: stents (n = 40) or no stents (n = 38) after IB. Consequently, our main endpoint could not be statistically answered. Improvement of dyspnea symptoms is noticeable in each group but lasts longer in the stent group. Stents do not change the survival curve but reduce unattended bronchoscopies. In the no stent group, 19 new TB were performed with 16 stents inserted contrasting with 10 rigid bronchoscopies and 3 stents placed in the stent group. In a subgroup analysis according to the oncologic management protocol following TB (first-line treatment and other lines or palliation), the beneficial effect of stenting on obstruction recurrence was highly significant (p < 0.002), but was not observed in the naïve group, free from first-line chemotherapy. CONCLUSION: Silicone stent placement maintains the benefit of TB after 1 year on dyspnea score, obstruction's recurrence, and the need for new TB. Stenting does not affect the quality of life and is suggested for patients after failure of first-line chemotherapy. It is not suggested in patients without previous oncologic treatment.

External beam radiation therapy combined with airway stenting leads to better survival in patients with malignant airway obstruction.

BACKGROUND AND OBJECTIVE: Malignant airway obstruction (MAO), a common complication of patients with advanced lung cancer, causes debilitating dyspnoea and poor quality of life. Two common interventions used in the treatment of MAO include bronchoscopy with airway stenting and external beam radiotherapy (EBRT). Data are limited regarding their clinical effectiveness and overall effect on survival. METHODS: A retrospective chart review of patients treated with airway stenting and/or EBRT at the Johns Hopkins Hospital for MAO between July 2010 and January 2017 was reviewed. Demographics, performance status, cancer histology, therapeutic intervention and date of death were recorded. Survival was calculated using cox regression analysis. RESULTS: Of the 606 patients who were treated for MAO, 237 were identified as having MAO and included in the study. Sixty-eight patients underwent rigid bronchoscopy and stenting, 102 EBRT and 67 a combined approach. Patients who underwent stenting hand an increased hazard ratio (HR) of death in comparison to those who received combination therapy (HR: 2.12, 95% CI: 1.02, 4.39), while there was a trend towards significance in the EBRT alone group in comparison to the combination therapy group (HR: 1.62, 95% CI: 0.93, 2.83). CONCLUSION: In this retrospective analysis, combination therapy with stenting and EBRT led to better survival in comparison to stenting or EBRT alone. Prospective cohort trials are needed to confirm these results.

Short-course Radiotherapy for Airway Stenting in Malignant Airway Obstruction: A Case Report and Literature Review.

Background: Malignant airway obstruction (MAO) secondary to tumor growth occurs in nearly a third of patients with lung cancer and portends a very poor prognosis if untreated. Treatment options include bronchoscopic intervention with tumor debulking, stent placement, endobronchial brachytherapy, or palliative radiotherapy. Case Report: This is a report of a 74-year-old woman with a medical history of metastatic lung adenocarcinoma, hospitalized for dyspnea, hemoptysis, and chest pain with a radiographic finding of MAO on chest X-ray and computed tomography. Patient underwent radiation with a total dose of 13 Gy in two once-weekly fractions of 6.5 Gy per fraction. Three days after the end of radiation treatment, chest X-ray showed a completely right lung re-expansion without atelectasis. Two weeks after radiotherapy treatment, the patient was discharged from hospital without pulmonary symptoms. Conclusion: A different fractionation with a lower equivalent dose in 2 Gy fraction compared to literature data showed efficacy in resolving MAO with excellent local control in the first three months of follow-up.

Tracheal Adenoid Cystic Carcinoma Successfully Treated With the Combined Core Out Technique, Cryoextraction, and Argon Plasma Coagulation: A Case Report.

We report the case of a 67-year-old male who presented with mild dyspnea two years ago, with increasing intensity, cough, and stridor on exertion. He underwent outpatient evaluation and received treatment for recurrent episodes of bronchitis and acute exacerbations of chronic obstructive pulmonary disease. His current medication included tiotropium 18 µg per day and salmeterol/fluticasone 50/500 µg twice daily. The patient received a short course of prednisolone at 40 mg per day for five days before admission. The physical examination showed a central stridor during both inspiration and expiration. Chest radiograph showed a normal lung parenchyma and no hilar enlargement. Spirometry revealed fixed airway obstruction. CT scan of the thorax revealed a 2.4 × 2.7 cm lobulated mass abutting the right side of the lower trachea with nearly complete obstruction. Due to the large tumor causing significant central airway obstruction, the medical team opted to remove the central airway mass through rigid bronchoscopy. Argon plasma coagulation was used to facilitate mass shrinkage. Mechanical mass removal was performed using a rigid bronchoscope. At the end of the treatment, re-evaluation by bronchoscopy exhibited no remaining mass. Histologic examination confirmed the diagnosis of a tracheal adenoid cystic carcinoma. No recurrence of the tumor was noted during 12 months of follow-up.

Review of the clinical outcomes of therapeutic bronchoscopy for central airway obstruction.

Central airway obstruction (CAO) is a debilitating condition with a significant impact on patient's quality of life and risk of hospitalization from respiratory failure. The causes of CAO can be both benign and malignant. Benign CAO may be idiopathic or secondary to other disease processes (infection, intubation, tracheostomy, etc.). Malignant central airway obstruction (MCAO) may occur in patients with primary lung malignancy as well as metastasis from other malignancies including renal cell, colon, and breast. In a cohort review, MCAO was found in up to 13% of patients with newly diagnosed lung cancer. The obstruction may occur either due to endoluminal disease, extrinsic compression, or a combination of both. Several bronchoscopic tools are available to manage such obstruction. Practice patterns and tools used to relieve CAO vary between institutions and may depend on physician preference, patient characteristics, emergency nature of the procedure, and nature of the obstruction. To quantify the effect and added value of such interventions, it is crucial to understand the clinical impact these interventions have on patients. The clinical impact of therapeutic bronchoscopy (TB) must then be weighed against the potential complications to justify its value. Early studies of TB for CAO included patients with both malignant and benign etiologies. The study population's heterogeneity makes it difficult to determine how TB affects clinical outcomes, as clinical outcomes are disease specific. The impact of TB for a MCAO may be different when compared to a benign CAO. Similarly, the clinical outcome of treating an idiopathic benign CAO may be different than that of a post tracheostomy airway obstruction. In this article, we will focus on the clinical outcomes of TB in MCAO. TB has been shown to have a clear impact on weaning from mechanical ventilation, dyspnea, health-related quality of life, survival and quality adjusted survival. The potential impact of TB on these outcomes should be weighed against the potential risk of complications. Understanding the factors associated with improved clinical outcomes will help physicians decide when and if TB is helpful. Future studies should focus on creating a decision analysis tool to further define decision thresholds.

Malignant Airway Obstruction and the Use of Nd:YAG Laser: A Systematic Review on Its Efficacy and Safety.

Endobronchial malignancies with significant airway obstruction can lead to multiple complications including pneumonia, and atelectasis over a period of time. Various intraluminal treatments have proven their value in palliative treatment for advanced malignancies. Nd:YAG (neodymium-doped yttrium aluminum garnet; Nd:Y3Al5O12) laser has established its role as a major palliative intervention due to its minimal side effects and improvement in quality of life by relieving local symptoms. The systematic review was conducted with the goal of elucidating the patient characteristics, pre-treatment parameters, clinical outcomes, and possible complications resulting from the use of the Nd:YAG laser. A thorough literature search for relevant studies was conducted on PubMed, Embase, and Cochrane Library from the inception of the idea to November 24, 2022. Our study included all original studies including retrospective studies and prospective trials, but excluded case reports, case series with less than 10 patients, and studies with incomplete or irrelevant data. A total of 11 studies were included in the analysis. The primary outcomes focused on the evaluation of pulmonary functional tests, postprocedural stenosis, blood gas parameters after the procedure, and survival outcomes. Improvement in clinical status, improvement in objective scale for dyspnea, and complications were the secondary outcomes. Our study shows that Nd:YAG laser treatment is an effective form of palliative treatment to provide subjective and objective improvement in patients with advanced and inoperable endobronchial malignancies. Due to the heterogeneous study populations in the studies reviewed and the presence of many limitations, more studies are still warranted to reach a definitive conclusion.

Malignant Airway Obstruction and Endobronchial Stent Placement: A Systematic Review on the Efficacy and Safety.

The systematic review aims to evaluate the efficacy and safety of endobronchial stent placement for malignant airway obstruction.  A comprehensive search was conducted across multiple databases to identify relevant studies. Cohort studies, randomized controlled trials, and case-control studies examining the outcomes of endobronchial stent placement in patients with malignant airway obstruction were included. Data on pre-treatment evaluation, such as pulmonary function testing, dyspnea severity scoring systems, arterial blood gas parameters, imaging, and degree of obstruction, were also collected. Primary outcomes of interest included post-procedure stenosis, pulmonary function testing evaluation, blood gas parameters, and survival outcomes. Secondary outcomes encompassed improvements in clinical status, dyspnea grade, and procedure-related complications. A total of 27 studies met the inclusion criteria and were included in the systematic review. The included studies demonstrated promising outcomes of endobronchial stent placement in managing malignant airway obstruction. Post-procedure airway diameters, pulmonary function testing, and blood gas parameters improved significantly. Survival outcomes varied among studies. Furthermore, endobronchial stent placement was associated with improvements in clinical status and dyspnea grade. Procedure-related complications ranged from pain, hemoptysis and mucus plugging to stent obstruction, migration and pneumothorax.  This systematic review suggests that endobronchial stent placement is an effective and safe intervention for managing malignant airway obstruction. It offers significant improvements in post-procedure stenosis, pulmonary function testing, blood gas parameters, and clinical outcomes. However, further studies with larger sample sizes and standardized reporting are warranted to better evaluate the long-term efficacy and safety of endobronchial stent placement for malignant airway obstruction.

Efficacy and Survival after Palliative Radiotherapy for Malignant Pulmonary Obstruction.

Introduction: The purpose of this study was to determine the efficacy of palliative radiotherapy (PRT) for patients with pulmonary obstruction from advanced malignancy and identify factors associated with lung re-expansion and survival. Materials and Methods: We reviewed all patients treated with PRT for malignant pulmonary obstruction (n = 108) at our institution between 2010 and 2018. Radiographic evidence of lung re-expansion was determined through review of follow-up CT or chest X-ray. Cumulative incidence of re-expansion and overall survival (OS) were estimated using competing risk methodology. Clinical characteristics were evaluated for association with re-expansion, OS, and early mortality. Treatment time to remaining life ratio (TT:RL) was evaluated as a novel metric for palliative treatment. Results: Eighty-one percent of patients had collapse of an entire lung lobe, 46% had Eastern Cooperative Oncology Group (ECOG) performance status 3-4, and 64% were inpatient at consultation. Eighty-four patients had follow-up imaging available, and 25 (23%) of all patients had lung re-expansion at median time of 35 days. Rates of death without re-expansion were 38% and 65% at 30 and 90 days, respectively. Median OS was 56 days. Death within 30 days of PRT occurred in 38%. Inpatients and larger tumors trended toward lower rates of re-expansion. Notable factors associated with OS were re-expansion, nonlung histology, tumor size, and performance status. Median TT:RL was 0.11 and significantly higher for subgroups: ECOG 3-4 (0.19), inpatients (0.16), patients with larger tumors (0.14), those unfit for systemic therapy (0.17), and with 10-fraction PRT (0.14). Conclusion: One-fourth of patients experienced re-expansion after PRT for malignant pulmonary obstruction. Survival is poor and a significant proportion of remaining life may be spent on treatment. Careful consideration of these clinical factors is recommended when considering PRT fractionation.

Central airway obstruction from lymphomatoid granulomatosis treated with an endobronchial stent.

Lymphomatoid granulomatosis (LG) is an extremely rare disease and is an unusual cause of central airway obstruction (CAO) with no standard of treatment in these conditions. LG is characterized by angioinvasion and angioinfiltration along with lymphohistiocytic cells. We present a 21-year-old female with LG who developed endobronchial lesions causing malignant CAO and acute hypoxic respiratory failure. She was treated with argon plasma coagulation, as well as a self-expandable metallic stent in the left main bronchus. Her stent was removed 4 months later after chemotherapy. Endobronchial stenting may be a useful bridge in patients who are undergoing more definitive treatment.

Predictors of survival and technical success of bronchoscopic interventions in malignant airway obstruction.

BACKGROUND: Malignant airway obstruction (MAO) leads to quality of life impairment and increased mortality. Interventional bronchoscopy allows airway patency restoring, leading to a better survival. We investigated predictors of survival and successful bronchoscopic intervention among MAO patients. METHODS: This observational prospective study enrolled 100 patients who were newly diagnosed with MAO. Survival was estimated with Kaplan-Meier method and curves compared by log-rank test. Multivariate analyses were performed using Cox proportional hazard models. Univariate and multivariate logistic regression were used for odds ratio calculation. RESULTS: A proportion of 73% of the patients were male with a median age was 62.5 years (range, 21-88 years). Lung cancer was the most common primary malignancy (74%). The majority had single (61%), endoluminal (62%) lesions and were classified as grade III in Myer Cotton scale (57%). The most used techniques comprised mechanical debulking (n=81) and laser therapy (n=68). Twenty-two airway stents were placed. While eleven patients were considered untreatable, technical success was achieved in 78%. Haemorrhage was the most common acute complication (16%). No deaths occurred as a result of the procedure. Median global survival was 8 months. Adjusting for age and Eastern Cooperative Oncology Group Performance Status (ECOG), extrinsic compression or mixed airway obstructions [hazard ratio (HR) =2.075; P=0.012], successful bronchoscopic intervention (HR =0.468; P=0.025) and initiation of cancer treatment (HR =0.373; P=0.006) were independent predictors of survival. The absence of distal airway patency on thoracic CT was independently associated with failure of the intervention [odds ratio (OR) =0.013; P<0.001]. CONCLUSIONS: Interventional bronchoscopy has proven to be an efficient and safe strategy to manage MAO patients. The patients who benefit the most in terms of survival are those with purely endoluminal lesions, in whom technical success was achieved and those whose cancer-specific treatment was initiated. Distal airway patency on thoracic CT predicts the technical success of bronchoscopic intervention.

Risk-score model to predict prognosis of malignant airway obstruction after interventional bronchoscopy.

BACKGROUND: Interventional bronchoscopy exhibits substantial effects for patients with malignant airway obstruction (MAO), while little information is available regarding the potential prognostic factors for these patients. METHODS: Between October 31, 2016, and July 31, 2019, a total of 150 patients undergoing interventional bronchoscopy and histologically-confirmed MAO were collected, in which 112 eligible participants formed the cohort for survival study. External validation cohort from another independent institution comprised 33 MAO patients with therapeutic bronchoscopy. The least absolute shrinkage and selection operator regression (LASSO) was applied to the model development dataset for selecting features correlated with MAO survival for inclusion in the Cox regression from which we elaborated the risk score system. A nomogram algorithm was also utilized. RESULTS: In our study, we observed a significant decline of stenosis rate after interventional bronchoscopy from 71.7%±2.1% to 36.6%±2.7% (P<0.001) and interventional bronchoscopy dilated airway effectively. Patients in our study undergoing interventional bronchoscopy had a median survival time of 614.000 days (95% CI: 269.876-958.124). Patients receiving distinct therapeutic methods of interventional bronchoscopy had different prognosis (P=0.022), and patients receiving treatment of electrocoagulation in combination with stenting and electrosurgical snare had worse survival than those receiving other options. Multivariate Cox analysis revealed that nonsmoking status, adenoid cystic carcinoma, and low preoperative stenosis length, as independent predictive factors for better overall survival (OS) of MAO patients. Then, the nomogram based on Cox regression and risk score system based on results from LASSO regression were elaborated respectively. Importantly, this risk score system was proved to have better performance than the nomogram and other single biomarkers such as traditional staging system (area under the curve 0.855 vs. 0.392-0.739). Survival curves showed that patients with the higher risk-score had poorer prognosis than those with lower risk-score (third quantile of OS: 126.000 days, 95% CI: 73.588-178.412 vs. 532.000 days, 95% CI: 0.000-1,110.372; P<0.001). CONCLUSIONS: Nonsmoking status, adenoid cystic carcinoma, and low preoperative stenosis length, were independent predictive factors for better OS of MAO patients. We proposed a nomogram and risk score system for survival prediction of MAO patients undergoing interventional bronchoscopy with good performance.

Role of radiotherapy in the management of malignant airway obstruction.

BACKGROUND: A significant proportion of lung cancer patients suffer from malignant airway obstruction (MAO). Palliative external beam radiotherapy (EBRT) is often used to control the symptoms caused by MAO. In this study, we report the effect of palliative EBRT on lung cancer with MAO and analyze the factors that influence it. METHODS: This study included 75 patients with MAO in lung cancer who underwent palliative EBRT, between 2009 and 2018 and were analyzed retrospectively. Change of dyspnea, tumor response, and overall survival (OS) were recorded. Univariate and multivariate analyses were performed to determine the prognostic factors for treatment outcomes. RESULTS: The median follow-up duration was 2.5 months, and median OS was 2.3 months. Out of 75 patients, dyspnea was improved in 46 patients (61.3%), and tumor was partially decreased in 39 patients (52%). Symptoms improved in all tumor responding patients. The symptom improvement was significantly affected by radiation dose and time to EBRT. The tumor response was significantly affected by pathology, radiation dose, and time to EBRT. CONCLUSIONS: Palliative EBRT is an effective and safe treatment option for patients with MAO in lung cancer. In particular, high-dose irradiation and prompt treatment can improve treatment results. KEY POINTS: SIGNIFICANT FINDINGS OF THE STUDY: In MAO patients, tumor response is an important factor for resolving dyspnea and improving survival rate. In order to increase the tumor response, high-dose irradiation and prompt treatment after symptoms occur are necessary. WHAT THIS STUDY ADDS: Our study reported the effects of EBRT and prognostic factors in MAO patients. We emphasize that palliative EBRT is a relatively safe and effective treatment in MAO patients, which is a complement to previous studies.

A Novel Tracheobronchial Stent Loaded with 125I Seeds in Patients with Malignant Airway Obstruction Compared to a Conventional Stent: A Prospective Randomized Controlled Study.

BACKGROUND: To evaluate the safety and efficacy of a novel radioactive bare metal stent (RBMS) compared with a conventional bare metal stent (CBMS) in patients with inoperable malignant airway obstruction. METHODS: This prospective study was approved by the Institutional Ethics Committee, and informed consent was obtained from each participant. Patients with malignant airway obstruction who had dyspnea were randomly assigned to receive RBMS or CBMS placement. The primary endpoint was stenosis grade, while the secondary endpoints were technical success, overall survival, and complications. A p value of <0·05 was considered statistically significant. RESULTS: Between September 2013 and July 2015, 66 patients with inoperable malignant airway obstruction received stent placement fluoroscopically (33 in either group). The median follow-up time was 154 days (range, 15-335 days). The baseline stenosis was immediately relieved in both groups after stent placement, and the stenosis grades in the RBMS group were significantly lower than that in the CBMS group since the second month (p < 0·05). The technical success rates of stent placement were 100% in both groups. The median survival in the RBMS group was significantly longer than that in the CBMS group (170 days vs. 123 days, p < 0·05). There was no significant difference in the incidence of complications between the two groups (p < 0·05). CONCLUSIONS: The placement of RBMS in patients with inoperable malignant airway obstruction is feasible and safe, and it significantly reduces restenosis and improves overall survival compared with the placement of CBMS.

Primary tracheal hyalinizing clear cell carcinoma.

Hyalinizing clear cell carcinomas (HCCC), now referred to as clear cell carcinomas (CCC) by the World Health Organization (WHO), are rare tumors usually arising from the salivary glands of the head and neck. We present the first case of a CCC originating from the trachea. A 66 year-old woman with history of hypertension, former smoker, presented to the emergency department reporting worsening shortness of breath. Computed chest tomography revealed a polypoid mass arising from the left posterior-lateral wall of the trachea. The patient developed worsening respiratory failure requiring mechanical ventilation. Bronchoscopy was completed which relieved a malignant airway obstruction and pathology revealed nests of cells with monomorphic nuclei and clear cytoplasm set in a hyalinized stroma. Using break apart probe fluorescence in situ hybridization testing the tissue revealed the presence of a recurring translocation of the Ewing sarcoma (EWSR1) gene, confirming the diagnosis. CCC is a rare primary airway tumor. CCC was first reported to originate in the lung in 2015. We present the first case of CCC arising from the trachea.

Review of Recent Important Papers in Interventional Pulmonology.

Interventional pulmonology is an innovative branch of pulmonary medicine that uses minimally invasive diagnostic and therapeutic approaches to airway, parenchymal, and pleural disease. The author reviews recent high-impact trials including randomized trials describing the use of endobronchial coils and valves in the management of severe emphysema. Novel approaches to the palliation of malignant and benign pleural effusion including increasing the frequency of drainage and instillation of talc via tunneled pleural catheters are also presented. In addition, a recent consensus paper discussing the optimal use and technique of cryobiopsy in diffuse parenchymal disease is reviewed, as well as a systematic review and meta-analysis of its diagnostic yield. The final trial reviewed in this article describes the preliminary safety and efficacy study of a novel endobronchial, balloon, and injection catheter for the local administration of chemotherapy into the airway mucosa so as to minimize the systemic absorption of these agents.

A new removable airway stent.

BACKGROUND: Malignant airway obstruction is a feared complication and will most probably occur more frequently in the future because of increasing cancer incidence and increased life expectancy in cancer patients. Minimal invasive treatment using airway stents represents a meaningful and life-saving palliation. We present a new removable airway stent for improved individualised treatment. METHODS: To our knowledge, the new airway stent is the world's first knitted and uncovered self-expanding metal stent, which can unravel and be completely removed. In an in vivo model using two anaesthetised and spontaneously breathing pigs, we deployed and subsequently removed the stents by unravelling the device. The procedures were executed by flexible bronchoscopy in an acute and a chronic setting - a 'proof-of-principle' study. RESULTS: The new stent was easily and accurately deployed in the central airways, and it remained fixed in its original position. It was easy to unravel and completely remove from the airways without clinically significant complications. During the presence of the stent in the chronic study, granulation tissue was induced. This tissue disappeared spontaneously with the removal. CONCLUSIONS: The new removable stent functioned according to its purpose and unravelled easily, and it was completely removed without significant technical or medical complications. Induced granulation tissue disappeared spontaneously. Further studies on animals and humans are needed to define its optimal indications and future use.

Restoration of Patency to Central Airways Occluded by Malignant Endobronchial Tumors Using Intratumoral Injection of Cisplatin.

RATIONALE: Malignant airway obstruction is commonly found in patients with lung cancer and is associated with significant morbidity and mortality. Relieving malignant obstruction may improve symptoms, quality of life, and life expectancy. OBJECTIVES: The objective of this study was to analyze our experience with bronchoscopic endobronchial intratumoral injection of cisplatin for malignant airway obstruction. METHODS: We conducted a retrospective analysis of patients with malignant airway obstruction treated with bronchoscopic intratumoral injection of cisplatin. Patient characteristics, histology, degree of airway obstruction, procedural methods, treatment cycles, performance status, and therapeutic outcomes were evaluated. Tumor response was analyzed based on bronchoscopic measurements performed on completion the of final treatment session. Adverse events and overall survival were abstracted. MEASUREMENTS AND MAIN RESULTS: Between January 2009 and September 2014, 22 patients (10 men, 12 women; mean age ± SD, 64.4 ± 9.5 yr) were treated with one to four injections of 40 mg of cisplatin mixed in 40 ml of 0.9% NaCl. Treatments were completed 1 week apart. The primary etiologies of airway obstruction included squamous cell carcinoma (n = 11), adenocarcinoma (n = 6), small cell carcinoma (n = 2), large cell undifferentiated carcinoma (n = 1), and metastatic endobronchial cancer (n = 2). Twenty-one of 22 patients were evaluable for response. The majority of patients (15/21, 71.4%) responded to therapy, defined as greater than 50% relative reduction in obstruction from baseline. Treatment response was obtained regardless of tumor histology, concurrent systemic therapy, number of treatment cycles administered, performance status, or use of additional ablative interventions. Responders had significantly improved overall survival as compared with nonresponders, although the difference was small. Severe treatment-related side effects or complications were not observed. CONCLUSIONS: Subject to the limitations of a single-center retrospective study and a subjective primary outcome measure, we have demonstrated the feasibility of improving the patency of central airways that are largely or completely occluded by endobronchial malignant tumor using intraluminal injection of cisplatin. Additional longer-term, larger-scale safety and comparative effectiveness studies of this palliative treatment modality are warranted.