(Chest. 2004;126:951-958.)
© 2004
American College of Chest Physicians
Use of the Dumon Y-stent in the Management of Malignant Disease Involving the Carina*
A Retrospective Review of 86 Patients
Hervé Dutau, MD;
Bénédicte Toutblanc, MD;
Carla Lamb, MD and
Luis Seijo, MD
* From the Thoracic Endoscopy Unit (Drs. Dutau and Toutblanc), Sainte Marguerite Hospital, Marseilles, France; the Interventional Pulmonary Program (Dr. Lamb), Lahey Clinic, Burlington, MA; and the Pulmonary Division (Dr. Seijo), Clínica Universitaria de Navarra, Pamplona, Spain.
Correspondence to: Hervé Dutau, MD, Thoracic Endoscopy Center, Hôpital Sainte Marguerite, 270 Blvd de Sainte Marguerite, 13009 Marseille, France; e-mail: hdutau{at}ap-hm.fr
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Abstract
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Objective: To study the efficacy of symptom relief and the safety of the Dumon Y-stent for central airway obstruction in malignant main carinal involvement and in malignant tracheoesophageal fistulas.
Design: A retrospective review.
Setting: Thoracic endoscopy referral center.
Patients and methods: The medical records of 86 patients who had undergone the placement of a Dumon Y-stent at our institution were reviewed and analyzed.
Results: Ninety Dumon Y-stents were placed in 86 patients to relieve symptoms of dyspnea, cough, and/or hemoptysis. Four of these patients required removal of that stent and replacement with a longer Dumon Y-stent due to tumor progression. There were only two instances of procedure-related adverse effects, which included coughing following stent placement lasting 1 week in one patient and stent migration in another patient. In the case of stent migration, the stent required immediate removal, and the patient experienced no adverse consequences. The remaining patients tolerated the stent well, and all experienced subjective symptomatic relief. There were no stent-related deaths. The average duration of a stent after placement was 133 days. The median time of survival following stent insertion was 181 days. Forty-five percent of all patients died at 3 months, and 72% died at 6 months.
Conclusion: The Dumon Y-stent proved to be useful and was well-tolerated in the management of malignant disease involving the main carina. It also provided successful palliation in patients with malignant tracheoesophageal fistulas.
Key Words: airway obstruction • bronchoscopy • esophageal cancer • lung cancer • stents • tracheoesophageal fistula
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Introduction
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Lung cancer is the most frequent malignancy in men, and its incidence continues to rise sharply in women worldwide. In France, lung cancer leads to 21,000 deaths per year.1 Despite advances in treatment, the prognosis for patients with lung cancer remains poor. The relative 1-year survival rate in Europe varies between 23% and 43%. The 5-year survival rate for patients with non-small cell lung cancer is approximately 15%, while that for small cell carcinoma does not exceed 5%.2 The survival rate is better for patients with resectable tumors.2
Thirty percent of patients with lung cancer will present with tumor-related central airway obstruction at the time of diagnosis.3 The most common symptoms are dyspnea, cough, and hemoptysis, which are distressing to the patient and limit quality of life, prompting pulmonologists to develop more effective palliative therapy.
Esophageal cancer is responsible for tracheoesophageal and/or bronchoesophageal fistulas, a serious complication that leads to recurrent aspiration, infection, and cough. Obstructive tracheobronchial tumors also may occur. These can be managed by interventional endoscopic means for symptomatic palliation, even in the setting of a very limited life expectancy, when surgical resection is not feasible.
Nonsurgical techniques such as laser photocoagulation, rigid bronchoscopic dilatation, and endobronchial stent placement are currently employed for the palliation of intrinsic obstruction of the airways.4 Stent placement often is needed in order to maintain the patency of the airways following laser or mechanical debulking.5 Malignant involvement of the lower trachea, the main carina, and the mainstem bronchi, as well as tracheoesophageal fistulas often require the placement of a Y-stent in inoperable and compromised patients for successful palliation.6 The existing stents, such as the Hood and the Freitag Y-stents,7 are limited by excessive rigidity of the tracheal portion, making placement difficult.
These limitations prompted us to develop a silicone Y-stent that has been perfected and used in our unit for 8 years. The Dumon Y-stent (Tracheobronxane Y; Novatech; Grasse, France) is dedicated to the palliation of lower tracheal and/or main carinal stenosis. It also may be used in the management of tracheoesophageal and/or bronchoesophageal fistulas. Its deployment is easily mastered, and it appears to be safe and well-tolerated by most patients.
In this retrospective study, we report our experience concerning the placement of the Dumon Y-stent in 86 patients who were referred to our medical center with inoperable malignant tracheobronchial disease between 1994 and 2002.
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Materials and Methods
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All patients undergoing the placement of a Dumon Y-stent at our interventional endoscopy unit were included in this retrospective study. All stents were placed in patients between July 1, 1994, and April 30, 2002, for malignant disease involving the main carina or because of a tracheoesophageal fistula. The aim of this study was to assess the palliative efficacy and safety of the Dumon Y-stent.
The patients presented to our service with respiratory symptoms of dyspnea, cough, and/or hemoptysis. Flexible bronchoscopy confirmed the presence of either a tracheobronchial obstruction or a tracheoesophageal fistula. The choice of stent was determined by the interventional pulmonologist. In general, the criteria for stent placement to palliate malignant airway disease at our institution included the following: tracheal tumor invading the main carina with or without involvement of one or both mainstem bronchi; tracheoesophageal and/or tracheomediastinal fistulas at the level of the carina; and extrinsic compression at the level of the main carina.
For every patient, we recorded the age, gender, location, and histology of the malignant process, the type of stent used, the duration of stent placement, outcome, and overall survival duration
(Table 1,1A
). Pulmonary function testing was not routinely performed.
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Table 1.. Demographic Characteristics, Histology, Date of Placement of the Y-Stent, Indications, Type of Dumon Y-Stent, Duration of Stent Placement, and Patient Outcome*
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Follow-up on all patients was available through April 30, 2002, including physician assessment at 1 and 3 months after the initial stent placement. At each assessment, the presence of new or aggravated respiratory symptoms was sought. Patients with new or worsening respiratory symptoms following stent placement underwent bronchoscopic evaluation. In the absence of symptoms, the patients were reevaluated at 6-month intervals as long as the stent remained in place. For those patients who required more than one stent, we calculated survival based on the date the first stent was placed.
The Y-stent (Fig 1
) is made of silicone with external tracheal diameters ranging from 15 to 19 mm. The internal surface is smooth and covered by a silicone varnish that reduces the porous nature of the stent, and appears to reduce the retention of secretions. The external tracheal surface is studded in order to prevent the migration of the stent except along the posterior wall. The absence of studs on the posterior wall facilitates orientation. We utilized stents of two different lengths and varying diameters (Fig 1). Our long stents contain a tracheal segment that is at least 50 mm in length, while the tracheal segment of our short stents ranges between 15 and 20 mm. In addition, the short stents contain tapered ends in order to allow ventilation of the right upper lobe bronchus. The standard diameters of the stents used were 15 or 16 mm in the trachea and 12 or 13 mm in the mainstem bronchi.
In our study, all Y-stents were placed with the patient under general anesthesia. At our center, care is taken to apply lidocaine to the vocal cords in order to achieve local anesthesia following induction. Subsequently, the patient is intubated with the rigid bronchoscope. An initial exploration of the tracheobronchial tree may be followed by a more detailed examination with the flexible bronchoscope. In the majority of our patients, intraluminal lesions were resected with forceps or by coring with the beveled tip of the rigid bronchoscope with or without laser photocoagulation. Tracheal recannalization must be performed carefully in a stepwise fashion in order to assure proper oxygenation and ventilation of the patient. We sometimes use an epinephrine solution (2 mg epinephrine in 500 mL saline solution) in order to achieve adequate hemostasis.8
The estimated tracheal diameter for stent size selection is extrapolated from the external diameter of the largest rigid bronchoscope that is able to pass through the involved airway. In general, the largest stent possible is used to reduce the risk of stent migration (adult woman, 15 mm; adult man, 16 mm). The absence of studs on the posterior aspect of the stent allows for the easy identification of the right and left branches. Deployment of the Y-stent is achieved through the channel of the rigid bronchoscope by employing either of the following two basic methods: the "pushing" technique, whereby the stent is deposited above the carina and then is advanced gently by pushing the stent, with the open rigid forceps placed at the bifurcation; or the "pulling back" technique, whereby both bronchial limbs (one cut shorter than the other) are inserted into the bronchus that is most involved by tumor and then are grasped with the forceps, slowly pulling the stent back until the shorter of the two bronchial limbs slips into position. The forceps then can be used to gently reposition the stent until it comes to rest flush against the carina. The removal of the Dumon Y-stent is simple and is almost identical to the technique used for removal of the conventional Dumon silicone stents, which has been described elsewhere.8 In order to maintain stent patency and to keep it free of airway secretions, we recommend the use of aerosolized saline solution three times daily.
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Results
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Eighty-six patients (75 men and 11 women) with a median age of 60.4 years were included in this retrospective study (Table 2 ). Sixty percent of patients had primary tracheobronchial malignancies. Thirty-six percent had esophageal cancer, and 3.5% had metastatic disease (Table 3
). Non-small cell lung cancer was the most frequently occurring tumor, accounting for 46.6% of cases (Table 3).
The most common indication for Y-stent placement (Table 4
) was isolated tracheobronchial obstruction in 53.4% of patients (Fig 2
). There were 27 cases (31.4%) of tracheoesophageal/bronchoesophageal fistulas (Fig 2). All of these patients had primary esophageal tumors. Extrinsic airway compression at the level of the main carina was an indication for stent placement in 14% of patients.
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Figure 2.. Distal tracheal, carinal, and proximal right main stem involvement before and after the Y-stent placement, and bronchoesophageal fistula due to a metallic stent inserted in the esophagus for an esophageal carcinoma before and after the Y-stent placement. Top: tracheobronchial obstructions. Bottom: tracheobronchial fistulas.
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Y-stents were placed in 90 patients (4 patients required removal of the initial Y-stent due to recurrent dyspnea from tumor progression and replacement with a longer Y-stent). Forty stents (44.5%) were long, and 50 stents were short (55.5%). The most common tracheal stent diameter was 16 mm. Twenty-one patients benefited from an additional straight Dumon silicone stent that was placed either proximal or distal to the Y-stent in order to achieve optimal palliation. Fourteen of these were placed in the trachea, and 7 were placed in the mainstem bronchi. Two patients who had previously undergone a pneumonectomy received a modified Y-stent with one shortened sealed bronchial limb. The Y-stents remained in place for an average of 133.6 days. One stent required immediate removal due to stent migration. The longest duration of stent placement was 1,255 days. Five patients were lost to follow-up following the placement of the stent, and an additional four patients underwent stent removal due to tumor regression. After 3 months of follow-up, 44 patients continued to benefit from the stent, while the other 13 patients died of their underlying disease. At 6 months, only 19 patients were living with stents in place.
In the patient subgroup requiring stent placement for aerodigestive tract fistulas, the mean (± SD) duration of stent placement was 92.5 ± 77.5 days (minimum, 3 days; maximum, 577 days). Only three of these patients were alive at 6 months.
The most common respiratory symptoms at presentation were dyspnea, cough and hemoptysis occurring in 74.3%, 32.6% and 15.6% of the patients respectively. Eighty-four patients experienced subjective symptomatic relief following stent placement. Quality-of-life questionnaires were not administered. Overall, the stents were well-tolerated. Only in one instance did a stent migrate, prompting immediate removal. No further intervention was required, although the patient succumbed to multiorgan failure in the ICU within 24 h of undergoing the procedure. Death in this case was attributed to the progression of the underlying malignancy. A second patient experienced severe coughing following stent insertion, which resolved spontaneously within 1 week. There were no other stent-related adverse effects. Stent removal was necessary in 12 patients. Four patients required the insertion of a new stent due to tumor progression. Indications for stent removal included tumor progression obstructing one end of the stent (nine patients), tumor regression following neoadjuvant chemotherapy (two patients), and migration of the stent in the setting of tumor progression (one patient).
The median survival time following stent insertion was 181 days. Five patients remained alive as of April 30, 2002. In two cases of long-term survival (ie, > 3 years), the stent was removed successfully. In one case, the stent had to be removed due to tumor progression.
Overall, 15 patients (19%) died within 1 month of stent insertion. At 3 months, 45% of all patients had died, and at 6 months 72% had died. Six patients survived for > 1 year.
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Discussion
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The optimal endoscopic management of tumors involving the main carina should be minimally invasive and should allow for the long-term control of potentially life-threatening tracheobronchial obstructions. It should also be applicable to a majority of patients, among them those deemed inoperable.9 Patient age and prognosis should not be considered absolute contraindications to what is essentially palliative minimally invasive care. In selected patients with tracheobronchial obstructions and amenable esophageal lesions, endoscopic management must always be considered without delay. Stent insertion in such patients can be effective when both endoluminal and extrinsic airway disease are encountered, after laser resection and prior to consolidating therapy, respectively. In the latter case, the Dumon Y-stent is particularly useful, insofar as those patients who benefit from consolidating therapy may not require permanent stenting. Unlike silicone stents, metal stents often become permanent fixtures in the patient’s airway, causing chronic irritation and unwanted side-effects.
As a palliative alternative following a lack of response to tumor-specific therapies, the Dumon Y-stent provides sustained improvement in quality of life.10 It relieves the acute dyspnea associated with complete tracheal obstruction in appropriately selected patients and minimizes the risk of recurrent infectious complications related to tracheoesophageal or bronchoesophageal fistulas.11 We found the Dumon Y-stent to be particularly useful in the latter subgroup of patients, having treated successfully > 20 fistulas with this device. Such fistulas occur in approximately 5 to 13% of patients with esophageal cancer involving the middle third of the esophagus and are often difficult to manage.1213 The diagnosis requires close evaluation during bronchoscopy of the membranous aspect of the distal trachea and proximal left mainstem bronchus. Fistulas often occur after radiation therapy and following the insertion of metallic esophageal stents for the treatment of dysphagia.14 Surgical management of this type of fistula is not justified when the goal of therapy is palliative rather than curative.15 The median survival time reported in the literature does not exceed 4 months regardless of the therapeutic approach, be it surgical or endoscopic.16 That notwithstanding, conservative management of these patients is not an option because it exposes them to life-threatening infection. We found that in 16 of our patients, the insertion of two stents (one in the esophagus and another in the trachea) provided effective palliative care by eliminating cough and minimizing infectious complications. One of our patients with a fistula remains alive after a successful response to therapy. In this patient, the stent was removed after 126 days.
The histologic tumor type is not a criterion for exclusion when considering endoscopic intervention. Despite the hemorrhagic potential of certain tumors, tumor debulking can be performed safely with the rigid bronchoscope under general anesthesia. We favor this approach over the flexible bronchoscope because it allows simultaneous suctioning, effective ventilation, and laser photocoagulation. In addition, the insertion of the stent can achieve hemostasis by itself. In our series, the average survival time was 181 days. Nineteen percent of our patients died at 1 month, and 45% died at 3 months. While the overall survival rate was poor, the immediate subjective relief of symptoms, which was the principal goal of stent placement, was thought to improve quality of life, even if this was not demonstrated.
Overall, the average placement duration of the Dumon Y-stent was 133 days, matching the expected survival duration in this patient population.2 Most patients died with their stent still in place.
Interventional pulmonologists agree for the most part that the recannalization of obstructed central airways by either mechanical or photoablative means constitutes the first step in treating a complex tracheobronchial obstruction.4 They disagree, however, on the choice of stent. Dissimilar opinions are a function of divergent experiences in the management of complex stenoses.17181920 Generally, the use of silicone or metal stents seems to depend primarily on the comfort level that the endoscopist has acquired with a particular device. Our experience concerns the exclusive use of the Dumon Y-stent for malignant involvement of the main carina. Undoubtedly, a randomized study comparing the various available Y-stents would be useful.
Several controversies warrant discussion. Our choice of stent was based on our previous and extensive experience with tubular silicone stents. The safety and efficacy of silicone stents in maintaining airway patency, particularly in cases of malignant tracheal stenosis is well-documented. The insertion of the Y-stent requires general anesthesia for the optimal calibration of the tracheobronchial lumen, but once the technique is mastered the placement of the stent can be achieved rapidly. Its removal is straightforward. In addition, excellent conformity to the contours of the trachea while minimizing contact with the mucosa limits granuloma formation. The endotracheal lumen remains free of tumor infiltration, which is a problem common to uncovered metallic stents. In our study, only one patient required the removal of the stent due to endoluminal obstruction. Furthermore, unlike silicone stents, metal stents are not removable. On the other hand, while metal stents require minimal routine care, proper silicone stent maintenance mandates conscientious nebulizer use in order to maintain hydration and therefore to avoid the inspissation of secretions. We recommend the use of a patient-administered aerosolized saline solution three times daily as long as the stent is in place. In addition, we avoid using the Y-stent in patients with a tracheostomy due to the high risk of stent obstruction by secretions.
In patients with a tracheoesophageal fistula, the subjective relief of aspiration manifested by a cough associated with drinking and eating might suggest that there is an adequate seal with the Y-stent, however, this was not objectively assessed in our study. Published guidelines15 for the palliative management of tracheoesophageal fistulas recommend stenting of both the tracheobronchial tree and the esophagus for optimal results. Fifty-five percent of the Y-stents placed in patients in this study were short in length. The short stent is chosen more frequently due to the more appropriate length of its bronchial segments when compared to the longer stent. Customized stents are also available. They guarantee an optimal fit and may reduce complications. Consideration of a customized stent may alleviate the need for additional stenting in less urgent cases.
The current study has several limitations. Objective pulmonary function parameters and arterial blood gas levels measured before and after the interventional procedure would have offered a more definitive means of determining the efficacy of airway recannalization. However, given the clinical status of the majority of our patients at the time of referral to our center, pulmonary function studies are difficult to obtain prior to stent placement. Our institution is a referral center for endoscopy, and subsequent access to all medical records from the patient’s primary care center is limited. Consequently, it was difficult to assess the contribution to symptom relief provided by chemotherapy or radiation therapy in this patient population. Finally, validated quality-of-life questionnaires were not performed. The physician questioned the patient about the outcome of their previous respiratory symptoms at each follow-up visit. The recurrence of dyspnea occurred in four cases, prompting bronchoscopic reevaluation. In all four cases, tumor progression was seen that required stent replacement.
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Conclusion
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In advanced malignant airway disease, survival is poor, and quality of life is limited by recurrent dyspnea, cough, and hemoptysis. In our experience, the Dumon silicone Y-stent provides a minimally invasive, safe, and effective palliative treatment for patients with malignant obstruction of the central airways. The advantages of the Dumon Y-stent include ease of placement and removal. Based on our experience, we suggest an algorithmic approach to the placement of the silicone Y-stent for malignant airway disease involving the main carina (Fig 3
).
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Figure 3.. Algorithmic approach to the placement of the silicone Y-stent for malignant airway disease involving the main carina. LMSB = left mainstem bronchus; RMSB = right mainstem bronchus; RUL = right upper lobe.
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Our review suggests that all patients with symptomatic central airway obstruction due to malignant carinal involvement and/or a malignant tracheoesophageal fistula be given consideration for this minimally invasive procedure, which is well-tolerated, safe, and effective. The option of the Y-stent also should be considered in the setting of additional medical therapies as a temporizing solution to extrinsic airway compression and subsequent tracheobronchial obstruction while awaiting a clinical response to treatment. The Dumon Y-stent appears to be particularly effective in palliating symptoms associated with malignant tracheoesophageal fistulas.
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Footnotes
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This research was supported by Novatech.
Received for publication February 20, 2003.
Accepted for publication March 2, 2004.
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References
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- Hill, C, Doyon, F (2003) Frequency of cancer in France. Bull Cancer 90,207-213[Medline]
- Janssen-Heijnen, ML, Coebergh, JW The changing epidemiology of lung cancer in Europe. Lung Cancer 2003;41,245-258[CrossRef][ISI][Medline]
- Minna, JD, Higgins, GA, Glastein, EJ Cancer of the lung. De Vita, VT Hellman, S Rosenberg, SA eds. Cancer principles and practice of oncology. 3rd ed. 1989,591-705 Lippincott. Philadelphia, PA:
- Colt, H, Harrell, J Therapeutic rigid bronchoscopy allows levels of care changes in patients with acute respiratory failure from central airways obstruction. Chest 1997;112,202-206[Abstract/Free Full Text]
- Diaz-Jimenez, JP, Farrero-Munoz, E, Martinez-Ballarin, JI, et al Silicone stents in the management of obstructive tracheobronchial lesion: 2 years experiences. J Bronchol 1994;1,15-18
- Cavaliere, S, Venuta, F, Foccoli, P, et al Endoscopic treatment of malignant airway obstructions in 2,008 patients. Chest 1996;110,1536-1542[Abstract/Free Full Text]
- Freitag, L, Tekolf, E, Eicker, R, et al Four years of palliation with airway stents. Results with 263 stent placements in 179 patients [abstract]. Eur Respir J 1993;17,A1548
- Dumon, JF Une endoprothèse trachéobronchique spécifique. Rev Mal Respir 1990;7,223-229[Medline]
- Mitchell, J, Mathisen, D, Wright, C, et al Resection for bronchogenic carcinoma involving the carina: long-term results and effect of nodal status on outcome. J Thorac Cardiovasc Surg 2001;121,465-471[Abstract/Free Full Text]
- Shiraishi, T, Kawahara, K, Shirakusa, T, et al Stenting for airway obstruction in the carinal region. Ann Thorac Surg 1998;66,1925-1929[Abstract/Free Full Text]
- Wong, K, Goldstraw, P Role of covered esophageal stents in malignant esophagorespiratory fistula. Ann Thorac Surg 1995;60,199-200[Abstract/Free Full Text]
- Fitzgerald, R, Bartles, D, Parker, E Tracheoesophageal fistulas secondary to carcinoma of the esophagus. J Thorac Cardiovasc Surg 1981;82,194-197[Medline]
- Nomori, H, Horio, H, Imazu, Y, et al Double stenting for esophageal and tracheobronchial stenoses. Ann Thorac Surg 2000;70,1803-1807[Abstract/Free Full Text]
- Altorki, N, Migliore, M, Skinner, D Esophageal carcinoma with airway invasion: evolution and choices of therapy. Chest 1994;106,742-745[Abstract/Free Full Text]
- Kvale, PA, Simoff, M, Prakash, UBS Lung cancer: palliative care. Chest 2003;123,284S-311S
- Vonk-Noordegraaf, A, Postmus, P, Sutedja, T Tracheobronchial stenting in the terminal care of cancer patients with central airways obstruction. Chest 2001;120,1811-1814[Abstract/Free Full Text]
- Bolliger, C, Probst, R, Tschopp, K, et al Silicone stents in the management of inoperable tracheobronchial stenoses. Chest 1993;104,1653-1659[Abstract/Free Full Text]
- Freitag, L, Tekolf, E, Stamatis, G, et al Clinical evaluation of a new bifurcated dynamic airway stent: 5 years experience with 135 patients. Thorac Cardiovasc Surg 1997;45,6-12[ISI][Medline]
- Miazawa, T, Yamakido, M, Ikeda, S, et al Implantation of ultraflex nitinol stents in malignant tracheobronchial stenoses. Chest 2000;118,959-965[Abstract/Free Full Text]
- Tojo, T, Iioka, S, Kiramura, S, et al Management of malignant tracheobronchial stenosis with metal stents and Dumon stents. Ann Thorac Surg 1996;61,1074-1078[Abstract/Free Full Text]
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Abstract
Introduction
