Malignant Esophageal Tracheobronchial Strictures: Parallel Placement of Covered Retrievable Expandable Nitinol Stents

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1 Acta Radiologica ISSN: (Print) (Online) Journal homepage: Malignant Esophageal Tracheobronchial Strictures: Parallel Placement of Covered Retrievable Expandable Nitinol Stents D. H. Nam, J. H. Shin, H.-Y. Song, G.-S. Jung & Y.-M. Han To cite this article: D. H. Nam, J. H. Shin, H.-Y. Song, G.-S. Jung & Y.-M. Han (2006) Malignant Esophageal Tracheobronchial Strictures: Parallel Placement of Covered Retrievable Expandable Nitinol Stents, Acta Radiologica, 47:1, 3-9 To link to this article: Published online: 09 Jul Submit your article to this journal Article views: 87 Full Terms & Conditions of access and use can be found at

2 ORIGINAL ARTICLE ACTA RADIOLOGICA Malignant Esophageal Tracheobronchial Strictures: Parallel Placement of Covered Retrievable Expandable Nitinol Stents D. H. NAM, J.H.SHIN, H.-Y. SONG, G.-S. JUNG & Y.-M. HAN Department of Radiology, Soonchunhyang University Chonan Hospital, College of Medicine, Soonchunhyang University, Chonan, Republic of Korea; Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; Department of Radiology, Ulsan Hospital, Ulsan, Republic of Korea; Department of Radiology, College of Medicine, Chonbuk National University, Chonju, Republic of Korea Nam DH, Shin JH, Song H-Y, Jung G-S, Han Y-M. Malignant esophageal tracheobronchial strictures: parallel placement of covered retrievable expandable nitinol stents. Acta Radiol 2006;47:3 9. Purpose: To assess the safety and clinical effectiveness of the parallel placement of covered retrievable expandable metallic stents in the palliative treatment of malignant esophageal and tracheobronchial strictures. Material and Methods: Under fluoroscopic guidance, parallel stents were placed in 12 symptomatic patients with both malignant esophageal and tracheobronchial strictures. Seven of these 12 patients also had an esophagorespiratory fistula (ERF) and one patient had an esophagocutaneous fistula. Technical success, clinical improvement, complications, and survival rates were evaluated. Results: A total of 28 esophageal and airway stents were successfully placed. The grade of dysphagia and dyspnea score significantly decreased after stent placement (P and 0.003, respectively). ERF and esophagocutaneous fistula were sealed off in all eight patients after esophageal stent placement; however, the esophagocutaneous fistula reopened 1 month later. Complications included stent migration or expectoration (n53), tracheal compression by the esophageal stent (n53), new fistula development due to covering membrane degradation of the esophageal stent (n51), and symptomatic sputum retention (n51). Stent removal was easily performed for two stents; one migrated stent and the other with covering membrane degradation. All 12 patients died within the mean survival period of days (range days). Conclusion: Parallel placement of covered retrievable expandable metallic stents is safe and effective for the palliative treatment of malignant esophageal and tracheobronchial strictures. Key words: Stents and endoprostheses; tracheal stenosis; esophageal stenosis; double stenting Ji Hoon Shin, M.D., Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, 388-1, Pungnap-2dong, Songpagu, Seoul , Republic of Korea (fax , . jhshin@amc.seoul.kr) Accepted for publication 2 September 2005 Locally advanced primary esophageal or lung cancer can cause stenoses of both the esophagus and airway as well as esophagorespiratory fistula (ERF) because of the very close anatomic relationship between the esophagus and the airway. In cases of esophageal cancer, tracheobronchial impingement or invasion has been reported in 34% of patients (3) and malignant ERF has been reported to be from 5% to 10% (1). Since COLT et al. (4) reported the usefulness of the placement of both esophageal and airway stents for malignant esophageal tracheobronchial strictures in 1992, there have been several reports on parallel stent placement for malignant esophageal tracheobronchial strictures (2, 4, 5, 9, 10, 19, 20). In most previous reports (2, 4, 5, 9, 10, 19, 20), silicone or covered expandable metallic stents were used for the esophagus and silicone or uncovered expandable metallic stents were used for the airway. Recently, the use of covered retrievable expandable metallic stents has been reported to be an easy, safe, and effective treatment modality for the palliative treatment of malignant esophageal or tracheobronchial strictures (14, 17). Covered retrievable expandable metallic stents have the advantages of not only effectiveness in preventing tumor DOI / # 2006 Taylor & Francis

3 4 D. H. Nam et al. ingrowth and sealing-off the fistula, but also stent removal in cases of stent-related complications such as stent migration. However, there have been no reports on the placement of covered retrievable expandable metallic stents for both airway and esophagus. The purpose of our study was to evaluate the safety and clinical effectiveness of the parallel placement of covered retrievable expandable metallic stents for the palliative treatment of malignant esophageal-tracheobronchial strictures. Material and Methods Patients In our retrospective review of 323 patients with esophageal stent placement and 75 patients with airway stent placement from March 1998 to October 2003, 12 patients received both esophageal and airway stent placement. There were 10 men and two women (age range years, mean 58.4 years). The causes of stenoses were esophageal cancer (n59), lung cancer (n52), and hypopharyngeal cancer (n51). In these patients, the direct reasons for stent placement were inoperable primary (n510) or recurrent (n51) malignancy or distant metastasis (n51) that caused both esophageal and tracheobronchial stenoses. All diagnoses were established by means of excisional, endoscopic, or percutaneous biopsy. Nine patients underwent chemotherapy (n51), radiotherapy (n52), or both (n56) before stent placement. ERF and esophagocutaneous fistula were combined in seven and one patients, respectively. The sites of esophageal stenoses were the cervical (n51), cervical and upper thoracic (n52), upper thoracic (n54), and middle thoracic (n55). The average length of the stenosis was 5.7 cm (range 4 9 cm). The sites of airway stenoses were the trachea (n58), left main bronchus (n53), and trachea with left main bronchus (n51). The average length of the stenosis was 3.5 cm (range 3 6 cm). The dysphagia score was established according to the previous reports (15): 05normal swallowing; 15ability to swallow semisolids; 25ability to swallow a soft diet; 35ability to swallow liquids only; and 45complete dysphagia. Before esophageal stent placement, the dysphagia scores were 3 in one patient and 4 in 11 patients (Table). The Hugh- Jones classification (14) was used to evaluate the improvement in respiratory function before and from 3 to 7 days after stent placement. Immediately before airway stent placement, there were 11 grade V patients and one grade IV patients (Table). Technique of stent placement and removal Esophageal stent placement. Polyurethane or PTFE (polytetrafluoroethylene)-covered esophageal stents (Niti-S esophageal covered stent; Taewoong, Ilsan, Korea) were used. The body part of each stent was 16 or 18 mm in diameter and mm in length. Eighteen-millimeter-diameter stents were chosen in cases of combined ERF. Topical anesthesia of the pharynx with an aerosol spray was performed before the procedure. A small amount (about 10 ml) of non-ionic contrast medium (Ultravist 300; Schering, Berlin, Germany) was swallowed by the patient for opacification of the esophageal stenosis. A inch exchange guidewire (Radifocus M; Terumo, Tokyo, Japan) was inserted through the mouth across the stricture. Under fluoroscopic guidance, after measuring the stricture length, the stent delivery system was advanced over the guide-wire across the stricture and stent deployment was performed. Tracheobronchial stent placement A polyurethane-covered tracheal or bronchial stent (Taewoong) was used. The tracheal stent was 16 or 20 mm in diameter and mm in length, and the bronchial stent was 10 or 12 mm in diameter and mm in length. Topical anesthesia of the pharynx and larynx was routinely achieved with an aerosol spray before the procedure. Under bronchoscopic guidance, a inch exchange guide-wire was inserted through the mouth across the stricture. After measuring the length of the stricture, a stent at least 1 cm longer than the stricture was then placed. Order of stent placement As for the order of stent placement, we placed the airway stent first and then esophageal stent if the symptoms of airway stenosis were dominant or the significant esophageal and airway stenoses were simultaneously combined. If the symptoms of esophageal stenosis were dominant with no or minimal symptoms of airway stenosis, we placed the esophageal stent first and then the tracheobronchial stent. Stent removal We removed the stents when there were complications such as stent migration. A stent retrieval set consists of a 13-F sheath, a 10-F dilator, a hook wire, and a inch guide-wire. The detailed technique of esophageal and tracheobronchial stent removal was the same as that described in our previous reports (6, 21).

4 Malignant Esophageal Tracheobronchial Strictures 5 Table. Patients characteristics and treatment for esophageal and tracheobronchial stenoses Stenosis site Stent First Second interval ES Airway Fistula stent stent (days) pre post pre post Grade of dyspnea Grade of dysphagia Survival (days) Cause of death Treatment of complications Complications Cause of stenoses No./age/sex 1/75/M Lung Ca. ME LMB ( ) ES (1) LMB (1) ( ) ( ) Pn. 34 2/59/M ES Ca. ME LMB (2) DP 375 LMB stent reinsertion ES (1) LMB (2) LMB stent expectoration 28 Pn. 1) ES stent insertion after SR 2) LMB stent insertion after SR ES (2) LMB (2) ) new ERF due to mb. degradation 2) LMB stent migration 3/69/M ES Ca. ME LMB (2) 4/59/F ES Ca. UE TR (+) ES (1) TR (1) TR compression TR stent insertion DP 131 5/49/M ES Ca. UE TR (+) ES (1) TR (1) TR compression TR stent insertion DP 56 6/63/M ES Ca. ME TR (+) ES (1) TR (1) (2) (2) DP 34 7/39/F ES Ca. CE TR (+) ES (1) TR (1) TR compression TR stent insertion Hm Hm. 2nd ES stent insertion ES (2) TR (1) ES stent migration with ERF reopening 8/63/M ES Ca. UE TR (+) 9/56/M HP. Ca. UE TR (+) TR (1) ES (1) (2) (2) Pn. 9 10/66/M Lung Ca. ME TR,MB (2) ES (1) HG (1) Sputum retention (2) Pn /70/M ES Ca. CE,UE TR (+) ES (1) TR (1) (2) (2) DP 14 12/33/M ES Ca. CE,UE TR (+) { ES (1) TR (1) (2) (2) DP 107 Numerals in parentheses are the numbers of placed stents, Ca.5cancer, M5male, F5female, ES5esophagus, HP5hypopharynx, CE5cervical esophagus, UE5upper thoracic esophagus, ME5middle thoracic esophagus, TR5trachea, LMB5left main bronchus, HG5hinged, SR5stent removal, DP5disease progression, Pn.5pneumonia, Hm.5hemorrhage, {5esophagocutaneous fistula. Follow-up and study endpoint All patients underwent barium study for esophageal stent and conventional radiography for tracheal or bronchial stent at 3 7 days following placement in order to verify expansion and position of the stent. Clinical examination and radiographic studies were performed 1 month after stent placement to detect stent migration or restenosis. Further follow-up was performed only in patients with recurrent symptoms. The dysphagia and dyspnea scores before and after stent placement were analyzed using the Wilcoxon signed-rank test using SPSS (version 10.1; SPSS, Chicago, Ill., USA); a P-valuev0.05 was considered statistically significant. According to the Society of Interventional Radiology (SIR) reporting standards, we defined major complications as those requiring further treatment or more hospitalization, and minor complications as those that resolved spontaneously or with conservative treatment (12). The Kaplan-Meier method was used to determine the cumulative patient survival period from the time of stent placement. The SPSS was used to perform the statistical analyses; a P-valuev0.05 was considered statistically significant. Results Stent placement and removal A total of 28 esophageal or tracheobronchial stents (14 esophageal, 8 tracheal, 5 bronchial, and 1 hinged stent, which is a combination of a tracheal and bronchial stent) were successfully placed in 12 patients. One esophageal stent and one tracheobronchial stent were placed in nine patients, but more than one esophageal stent and one tracheobronchial stent were placed in three patients: one patient (patient no. 2) underwent placement of a second bronchial stent after spontaneous expectoration of the first bronchial stent; another patient (patient no. 3) underwent placement of a second esophageal stent after removal of the first stent in which the covering membrane was degraded and of the second bronchial stent after removal of the first migrated bronchial stent; the one remaining patient (patient no. 8) underwent placement of a second esophageal stent coaxially into the first stent to manage ERF reopening secondary to migration (distal, a few centimeters) of the first esophageal stent because the second esophageal stent might migrate in the same way as the first esophageal stent in case of reinsertion after removal. Two stents were therefore removed for one esophageal stent with covering membrane degradation and one migrated bronchial stent.

5 6 D. H. Nam et al. As for the order of stent placement; in 11 patients, an esophageal stent was placed first and was followed by tracheobronchial stent placement, because the symptoms of dysphagia or aspiration by ERF were the main complaint without dyspnea. The reasons the parallel tracheal or bronchial stent was placed after esophageal stent placement were as follows: growing tumor aggravating airway stenosis or causing ERF in eight patients and gradually expanding esophageal stent causing dyspnea in three patients (patient nos. 4, 5, 7) (Fig. 1). In the remaining patient (patient no. 9), with severe stenosis of both the esophagus and airway stenosis, esophageal and tracheal stents were placed during the same procedure; the tracheal stent was placed first, followed by placement of the esophageal stent, because an expanded esophageal stent might deteriorate the tracheal stenosis. Clinical improvement ERF was sealed-off without further aspiration symptoms after esophageal stent placement in all seven patients with ERF before stent placement. There was no reopening of the ERF until death in these seven patients after both esophageal and airway stents. Esophagocutaneous fistula before stent placement was also sealed off after esophageal stent placement in one patient (patient no. 12), although it reopened 1 month following stent placement. The median dysphagia score improved from 4 to 2 one week after esophageal stent placement; the grade of dysphagia significantly decreased after esophageal stent placement (Wilcoxon signed-rank test, P50.002). The median dyspnea score improved from 5 to 3 one week after airway stent placement and the grade of dyspnea significantly decreased after airway stent placement (Wilcoxon signed-rank test, P50.003). Complications and reinterventions There were no minor complications. As for major complications, stent migration or expectoration (n53), tracheal compression by esophageal stent (n53), new ERF development due to covering membrane degradation of the esophageal stent (n51), and symptomatic sputum retention (n51) occurred. Migration or expectoration of two bronchial stents and one esophageal stent occurred in three patients 1 25 days (average 8.4 days) following stent placement. Tracheal compression developed in three patients after esophageal stent placement (Fig. 1). In these patients, tracheal stent was placed 7 28 days (average 17.0 days) after esophageal stent placement. A new esophagobronchial fistula developed in one patient (patient no. 3) 157 days after esophageal stent placement between the mid-portion of the esophageal stent and the left main bronchus. In this patient, the esophageal stent was removed and placement of a second esophageal stent followed. There was covering membrane degradation in the removed stent. Sputum retention was symptomatic and aggravated after hinged stent placement in one patient with lung cancer (patient no. 10). The sputum was yellowish and purulent in this patient, who died from increased sputum and subsequent pneumonia. Survival During the follow-up period, all 12 patients died days after parallel esophageal tracheobronchial stent placement due to disease progression (n56), pneumonia (n54), or hemorrhage (n52). Massive hemorrhage occurred 7 and 48 days after parallel stent placement in 2 patients (patient nos. 7 and 8), who died several hours after the onset of massive hemorrhage. The mean survival period SD was days (95% CI: 14.46, ) in all 12 patients. Discussion The indications for covered stent placement in our study in both esophagus and airway were advanced malignant tumor involving both organs, airway compression by an expanding esophageal stent or growing masses, or insufficient sealing of the combined ERF despite esophageal stent placement. After placement of double stents, symptoms of dyspnea or dysphagia were relieved in most study patients. While the use of uncovered expandable metallic stents have some limitations, such as progressive tumor ingrowth or unsuitability for ERF, covered ones can improve the long-term patency of the stent lumen and seal off the ERF effectively, despite the risk of stent migration (14, 16). On the other hand, although silicone stents have the advantages of maintaining the patency of the lumen of the esophagus or airway and of effectively sealing-off the ERF, general anesthesia is usually required for insertion (16). Therefore, we believe that covered expandable metallic stents are superior to uncovered expandable metallic stents or silicone stents if they can be removed when there are complications such as stent migration. The removal technique used in this study is safe because the stent can easily be collapsed with the hook-like device, pulled upward into the sheath, and the entire assembly withdrawn

6 Malignant Esophageal Tracheobronchial Strictures 7 Fig. 1. A 39-year-old woman with esophageal cancer and esophagotracheal fistula (patient no. 7). A. Lateral esophagography shows esophagotracheal fistula (arrow) and segmental luminal narrowing (arrowheads) in the cervical esophagus. B. Radiography obtained 1 week after esophageal stent shows diffuse tracheal narrowing (arrows). C. Radiography obtained after tracheal stent placement to relieve dyspnea. D. Esophagography obtained 1 week after tracheal stent placement shows good flow of contrast medium through the esophageal stent without visualization of the fistula and fully expanded tracheal stent (arrows).

7 8 D. H. Nam et al. without difficulty because the stent is completely covered and optimally designed for removal (4, 6, 14, 17). The successful closure rate of the ERF by an esophageal covered metallic stent is reported to be about % (1, 7, 13). In particular, patients with ERF at the cervical esophagus near upper esophageal sphincter and patients with a higher chance of esophageal stent migration owing to previous Ivor-Lewis surgery would have higher failure rates (14, 15, 18). In the cases described in the previous paragraph and in the cases with coexisting esophagus and airway stricture, tracheal or bronchial stent placement should be considered with or without esophageal stent placement. The parallel stent placement was useful, but there were also complications after stent placement, such as stent migration, tracheal compression, new fistula development due to covering membrane degradation, and sputum retention. The migration incidence of covered metallic stents is reported to be about 5 32% in malignant esophageal stricture (17) and 17% in malignant tracheobronchial stricture (14). The incidence of stent migration or expectoration in this study was three stents (3/28, 11%) in three patients (3/12, 25%), which was comparable with the studies cited in the literature. However, our stents could be easily removed using a retrievable hook. Tracheal compression by expanding esophageal stents developed in three of our study patients. The significant airway compression due to extrinsic compression by the esophageal stent was reported in patients with esophageal cancer because of lack of space in the bony thoracic inlet (9, 10). NICHOLSON (9) advocated prophylactic placement of the airway stent prior to esophageal stent placement in order to avoid further airway compromise secondary to esophageal stent expansion. Therefore, it would be important to carefully evaluate the airway stenosis with computed tomography or bronchoscope before esophageal stent placement even if the patient had minimal respiratory symptoms. A new fistula between the esophagus and the airway can develop due to necrosis of both the esophageal and airway walls due to the pressure of the stents (10). Initial placement of stents with smaller diameters and use of more dynamic expandable metallic stents rather than silicone stents in the airway may provide sufficient symptom palliation and reduce the propensity for fistula formation (10). For these reasons, no study patients developed fistulas secondary to tissue pressure necrosis by the stents; rather, there was one patient with fistula development secondary to degradation of the covering polyurethane membrane. We now use PTFE as a covering membrane as this is a very degradationresistant material. The mean survival period of the 12 study patients was days (range days), which is included in the range days of mean survival time summarized from several previous reports (4, 10, 19) that have included more than 8 and fewer than 13 patients. The cause of death in two of our study patients was massive hemorrhage. BINKERT et al. (2) described two fatal complications after parallel esophageal tracheal stent placement with Gianturco-Rosch Z stents. The explanation for the bleeding was pressure necrosis and perforation of the esophageal venous plexus from severe focal tissue compression between the esophageal and tracheal stent struts. If it is presumed that massive hemorrhage originates from eroded vessels because of broken stents (8), it can be expected that the incidence of fatal hemorrhage might be reduced in patients with covered metallic stent placement. In our study, two patients died from massive hemorrhage 7 and 48 days, respectively, after parallel stent placement. It is difficult to determine whether the hemorrhages were related to the stents or to the natural disease course because no autopsy was performed. Bleeding rates of 5 8% have been reported in patients with esophageal cancer who were untreated, thereby representing the natural progression of the underlying malignancy (11). In conclusion, parallel placement of covered retrievable expandable metallic stents is safe and effective for the palliative treatment of malignant esophageal and tracheobronchial strictures. The complication rates were reasonably acceptable and interventional management is useful for managing such complications. Acknowledgment This study was supported by a grant ( ) from the Asan Institute for Life Sciences, Seoul, Korea. References 1. AbadalJM, EchenagusiaA, SimoG, CamunezF. Treatment of malignant esophagorespiratory fistulas with covered stents. Abdom Imaging 2001;26: BinkertCA, PetersenBD. Two fatal complications after parallel tracheal-esophageal stenting. Cardiovasc Intervent Radiol 2002;25: ChoiTK, SiuKF, LamKH, WongJ. Bronchoscopy and carcinoma of the esophagus II. Carcinoma of the

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