Cardiovasc Intervent Radiol (2014) 37:750–755 DOI 10.1007/s00270-013-0735-7

CLINICAL INVESTIGATION

NON-VASCULAR INTERVENTIONS

Fluoroscopically Guided Balloon Dilation for Benign Bronchial Stricture Occurring after Radiotherapy in Patients with Lung Cancer Young Chul Cho • Jin Hyoung Kim • Jung-Hoon Park • Ji Hoon Shin • Heung Kyu Ko Ho-Young Song



Received: 27 June 2013 / Accepted: 11 August 2013 / Published online: 3 October 2013 Ó Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2013

Abstract Purpose To evaluate the safety and clinical effectiveness of fluoroscopically guided balloon dilation in patients with benign bronchial stricture occurring after radiotherapy (RT). Methods From March 2002 to January 2013, ten patients with benign bronchial stricture occurring after RT underwent fluoroscopically guided balloon dilation as their initial treatment. Technical success, primary and secondary clinical success, improvement in respiratory status, and complications were evaluated. The symptomatic improvement period was calculated. Results A total of 15 balloon dilation sessions were performed in ten patients, with a range of 1–4 sessions per patient (mean 1.5 sessions). Technical success was achieved in 100 %. Six of the ten patients exhibited no symptom recurrence and required no further treatment until the end of follow-up (range 4–105 months). Four patients

Y. C. Cho  J. H. Kim (&)  J.-H. Park  J. H. Shin  H. K. Ko  H.-Y. Song Department of Radiology, Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, 388-1, Poongnap 2-dong, Songpa-gu, Seoul 138-736, Republic of Korea e-mail: [email protected] Y. C. Cho e-mail: [email protected] J.-H. Park e-mail: [email protected] J. H. Shin e-mail: [email protected] H. K. Ko e-mail: [email protected] H.-Y. Song e-mail: [email protected]

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(40 %) experienced recurrent symptom, and two of four patients underwent repeat balloon dilations. The remaining two patients underwent cutting balloon dilation and temporary stent placement, respectively, and they exhibited symptom improvement after adjuvant treatment until the end of our study. Finally, primary clinical success was achieved in six of ten patients (60 %) and secondary clinical success was achieved in eight of ten patients (80 %). The mean symptom improvement period was 61.9 ± 16 months (95 % confidence interval 30.6–93.3). Conclusion Fluoroscopically guided balloon dilation seems to be safe and clinically effective for the treatment of RT-induced benign bronchial stricture. Temporary stent placement or cutting balloon dilation could be considered in patients with benign bronchial strictures resistant to fluoroscopically guided balloon dilation. Keywords RT-induced benign bronchial stricture  Fluoroscopically guided balloon dilation  Covered retrievable expandable metallic stent  Cutting balloon dilation

Introduction Radiotherapy (RT) is one of the most effective and commonly used treatments for non-small cell lung cancer. It is the primary treatment modality used for locally advanced unresectable tumors, and it is usually provided together with chemotherapy [1]. However, high-dose RT appears to cause a fibrosing mediastinitis with extrinsic airway compression, and it may cause injury to the bronchi, with resulting bronchitis and fibrosis, followed by stenosis [2]. Even though bronchial stenosis in patients treated with RT for lung cancer is a complication not often seen, it has been

Period between the initial radiation treatment and the balloon dilation a

65/M 10

NSCLC non-small cell lung cancer, LMB left main bronchus, LLLB right lower lobar bronchus, RMB right main bronchus, RMLB right middle-lobe bronchus, D/L diameter (mm)/length (mm), SP temporary stent placement, CBD cutting balloon dilation

None

None None 298 1 2 10/3 1 2 LMB 6,600

None

63/M 9

NSCLC

None

None 59

63 3

1 3

5 10/4

8/4 1

1 2

1 LMB

LMB 6,600

5,500 67/M 8

NSCLC

64/M 7

NSCLC

None

Blood-tinged sputum None

None 58

210 1

1 2

3 10/4

12/4 3

1 2

1.5 RMB

LMB 7,020

5,040 56/M 6

NSCLC

51/M 5

NSCLC

None

Blood-tinged sputum None 370 2 3 12/6 4 2 RMB 6,500

None

57/M 4

NSCLC

None 615 1 3 10/4 1 1.8 LMB 6,500

51/F

NSCLC

None 131 1 3 8/4 1 1 RMLB 6,600

None

3

NSCLC

CBD

TSP 165

279 3

2 3

4 10/4

12/4 1

1 1.5

1.5 LMB

LMB 6,600

6,600

50/F 2

NSCLC

49/M 1

NSCLC

After treatment No. of balloon procedures Length (cm) Site

Radiation dosage (cGy) Disease Age (year)/ sex Patient no.

Before the procedure, the severity and length of the strictures were evaluated by chest radiography, CT including three-dimensional reconstructions, and bronchoscopy. Informed consent was obtained from all patients at the time of the procedure. The pharynx and larynx were routinely

Table 1 Summary of patient characteristics and clinical outcomes

Balloon Dilation Procedure

Balloon dilation

Patient Population

Stricture

Materials and Methods

Informed consent for balloon dilation was obtained for each patient. This retrospective study was approved by our institutional review board. From March 2002 to January 2013, the patient cohort consisted of ten patients (eight male and two female subjects) ranging in age from 49 to 67 years (mean 57 years) who underwent fluoroscopically guided balloon dilatation for treatment of benign bronchial strictures occurring after RT. The patient characteristics are summarized in Table 1. The inclusion criteria for balloon dilatation were documented benign bronchial stricture occurring after RT and inability to pass a bronchoscope through the stricture. The diagnosis of bronchial stricture was established by bronchoscopy and computed tomography (CT) before the procedure. The radiation dose ranged from 5,040 to 7,020 cGy over a period of 2–8 weeks and RT-induced, clinically significant bronchial stricture developed 2–21 months (median 6 months) after RT.

Before treatment Size (D/L)

Hugh-Jones grade

Interval (day)a

Adjuvant treatment

sporadically reported [3–8]. Hayakawa et al. [9], in their series of five patients with epidermoid carcinoma of the lung and who were treated with RT delivered to the hilar region, have reported the development of marked stenosis of the proximal bronchi, although without tumor progression. Recently, tracheobronchial balloon dilation has become an accepted initial therapy for patients with benign bronchial strictures, primarily because balloon dilation is associated with lower morbidity and mortality rates than corrective surgery [10–14]. It also provides prompt and durable palliation for patients who are ineligible for surgical treatment. However, most indications for balloon dilation have been related to anastomotic or tuberculosis bronchial strictures [14, 15]. To our knowledge, there are no reports focusing on the fluoroscopically guided balloon dilation of RT-induced, benign bronchial stricture. Therefore, the purpose of our study was to evaluate the safety and clinical effectiveness of fluoroscopically guided balloon dilation in patients with benign bronchial stricture occurring after RT.

None

751 Complications

Y. C. Cho et al.: Fluoroscopically Guided Balloon Dilation

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752

anesthetized topically using an aerosol spray (lidocaine 10 %) followed by intravenous administration of 0.05 mg/ kg midazolam to induce conscious sedation and for monitoring of the oxygen saturation. Under bronchoscopic guidance, a 0.035-in. exchange guide wire (Radiofocus Guide Wire, Terumo, Tokyo, Japan) was inserted across the stricture into the distal portion of the trachea. After removing the bronchoscope, a straight 5F graduated catheter with both an end hole and side holes (Cook, Bloomington, IN, USA) was passed over the guide wire into the distal portion of the stricture, after which *5 mL of contrast medium (Ultravist 300, Bayer Healthcare, Wayne, NJ, USA) was injected through the catheter in order to evaluate the degree and length of the stricture. After measuring the length of the stricture, an 8- to 12-mm-diameter angioplasty balloon catheter (Boston Scientific/Medi-tech; Watertown, MA, USA; and Cordis; Roden, the Netherlands) was passed over the guide wire under fluoroscopic guidance, correctly positioned across the stenosis, and manually inflated using diluted water-soluble contrast medium. During each session, two or three serial balloon inflations were performed for 10–20 s in each session, until the balloon waist formed by the airway stenosis disappeared or until the patient could not tolerate further inflation. A session was defined as any procedure performed on a single day. Bronchoscopy was performed immediately after the procedure in order to evaluate the degree of dilation of the stenotic segment and to identify any possible complications. Follow-up Patients were subsequently followed by clinical examination, chest radiography, or bronchoscopy to evaluate the treatment efficacy at 1–3 days, 1, 2, 3 months, and then every 3 months. Follow-up CT including three-dimensional imaging was performed 1, 2, or 6 months after the balloon treatment in order to evaluate improvement in the stricture. Patients were asked to visit our hospital if their symptoms recurred. Patients with clinical or bronchoscopic evidence of restenosis underwent repeat balloon dilation or other appropriate procedures. In patients with short-term (within 4 weeks after balloon dilation) recurrence or aggravated stricture after balloon dilation, other procedures were considered. In one patient who underwent temporary stent placement for short-term recurrence after balloon dilation, the stent was removed using a retrieval hook under fluoroscopic guidance 6 months after stent placement. When the hook grasped and pulled the drawstring of the proximal end of the stent into a sheath, the proximal end collapsed and the stent could be removed [16]. At the end of the study, all patients or a family member were contacted by telephone to obtain information concerning the patient’s respiratory status.

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Definition and Data Analysis Technical success was defined as an increase in the bronchial diameter of the stenotic segment after balloon dilation, as observed on bronchoscopy, and easy passage through the stricture of an adult bronchoscope. Primary clinical success was defined as improvement of their symptoms after one session of fluoroscopically guided balloon dilation and no evidence of recurrence without subsequent balloon dilation until the end of the follow-up period or their death. Secondary clinical success was defined as improvement of their symptoms after one or repeated balloon dilations for the recurrent bronchial stricture and no further recurrence without any treatment such as cutting balloon, temporary stent placement or surgery until the end of the follow-up period or their death. Recurrence of symptoms was defined as return of the patient’s obstructive symptoms similar to those experienced before the procedure. The symptomatic improvement period after the procedure was calculated by the Kaplan–Meier method. All statistical analyses were performed by SPSS (version 21; SPSS, Chicago, IL, USA).

Results Fluoroscopically guided balloon dilation was successfully performed in all patients (100 %). The total number of balloon dilation sessions was 15 in ten patients, with each patient undergoing one to four sessions (mean 1.5 sessions). Blood-tinged sputum was seen in two patients, although it resolved within 4 h. No immediate, serious procedure-related complications occurred in any of our study patients. There were no major complications requiring further treatment or surgery. Of the ten study patients, six (60 %) experienced relief of their symptoms after a single session of fluoroscopically guided balloon dilation and had no evidence of recurrence until the end of the follow-up period or their death (range 4–105 months, mean 39 months) (Fig. 1). In the remaining four patients (40 %), symptoms recurred 25 days– 7 months (mean 4 months) after initial balloon dilation, for which they subsequently underwent repeat balloon dilation (n = 2), cutting balloon dilation (n = 1), or temporary stent placement (n = 1). Two of four patients experienced recurrence of their dyspnea 4 and 6 months, respectively, after initial balloon dilation. They underwent repeat balloon dilation (three and four sessions, respectively) for the recurrent bronchial stricture, and no further recurrence was seen by the time the study ended after repeat balloon dilation (25 and 105 months, respectively). The remaining two patients underwent cutting balloon dilation (8-mm-diameter, 2-cm-

Y. C. Cho et al.: Fluoroscopically Guided Balloon Dilation

753 b Fig. 1 A 51-year-old woman (patient 3) with bronchial stricture

detected 4 months after RT. A Three-dimensional surface-rendered reconstruction CT scan performed 7 days before balloon dilation reveals a severe right middle lobe bronchial stricture (arrow). B The stenosis was dilated using an 8-mm balloon catheter (arrow). C Three-dimensional surface-rendered reconstruction CT reveals marked improvement in the stricture (arrow) after balloon dilation

Seongnam, Korea), respectively, as a result of the shortterm recurrence within 4 weeks after balloon dilation. In the patient who underwent temporary stent placement, the stent was electively removed 6 months after stent placement, and the patient experienced symptom relief and no evidence of recurrence until the end of the follow-up period (11 months). The patient who underwent cutting balloon treatment also experienced symptom relief but died of pneumonia unrelated to the procedure 6 months after cutting balloon dilation. During the follow-up period of 4–105 months (mean 39 months), four of ten patients (40 %) experienced recurrence of their dyspnea after fluoroscopically guided balloon dilation. Finally, primary clinical success was achieved in six of ten patients (60 %) and secondary clinical success was achieved in eight of ten patients (80 %) who underwent fluoroscopically guided balloon dilation. The mean symptom improvement period was 61.9 ± 16 months (95 % confidence interval, 30.6–93.3) (Fig. 2).

Discussion RT is an important treatment modality in the management of patients with non-small cell lung cancer. It is used as a single modality or in combination with other modalities

long, Peripheral Cutting Balloon, Boston Scientific, Natick, Massachusetts) and placement of a temporary stent (10mm-diameter, 4-cm-long a retrievable expandable nitinol stent internally covered with silicone, S&G Biotec,

Fig. 2 Cumulative symptomatic improvement period after balloon dilation in ten patients (Kaplan–Meier analysis)

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with the intention of cure or palliation [17]. However, adverse effects of RT on the lung parenchyma, i.e., acute pneumonitis and chronic fibrosis, are well known and have been extensively studied [18]. A landmark report described a dose–response effect in lung cancer with improved outcome with higher doses of conventionally delivered RT [19]. On the basis of this report, 60 Gy became the standard dose for patients with lung cancer. However, with dose escalation, it is possible that high-dose RT produces a fibrotic reaction in the mediastinum. This in turn could produce extrinsic compression of the major airways which has been known to occur after other injurious processes such as fungal infections (primarily histoplasmosis), tuberculosis, and sarcoidosis and is known as sclerosing mediastinitis [20–22]. RT-induced bronchial stricture is an uncommon complication. The reported incidence of bronchial stenosis after RT in patients with lung cancer is *3–8 % [2, 23] and it has been managed by surgical resection, laser therapy, balloon dilation, and stent placement [10, 11, 24–26]. Fluoroscopically guided balloon dilation has been demonstrated to be a safe and effective procedure for the treatment of benign airway strictures and has initial clinical success rates of 68–100 % [10, 27, 28]. For these reasons, we chose balloon dilation as the initial treatment option for RTinduced bronchial stricture. We found that radiologic management is effective as a therapeutic option for patients with RT-induced bronchial stricture. Our current study demonstrated that treatment using balloon dilation under fluoroscopic guidance is associated with not only a high technical success rate (100 %) but also with a high clinical success rate (60 %) in patients who developed RT-induced bronchial stricture, and there were no significant or immediate complications after balloon dilation. We are unsure regarding the factors related to our high success rates, although possible explanations are that RT-induced bronchial stricture seems to be a short-segment stricture (2 cm or less) consisting of a larger number of short strictures compared with the other benign bronchial strictures [14, 29, 30]. In our study, all of the patients had short strictures \2 cm in length (mean, 1.6 cm), and therefore, the length of the stricture could have played a role in shorter strictures being more successful than long strictures. The mean symptomatic improvement period was 61.9 ± 16 months after balloon treatment during the follow-up period (4–105 months, mean 39 months). Despite the 60 % clinical success rate in our study, the recurrence rate was 40 %, which seems to indicate that the recurrence rates of RT-induced bronchial stricture after the initial balloon dilation are within the range of those of other benign bronchial strictures such as noninflammatory bronchial strictures (54 %), tuberculous strictures (30 %), and anastomotic strictures (50 %) [10, 13, 27, 31].

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There are some reports regarding the temporary placement of a covered retrievable metallic stent in patients with benign bronchial strictures resistant to conventional balloon dilation. Kim et al. [29] reported the clinical outcome 2–6 months after placement of 30 covered retrievable expandable metallic stents in 24 patients with benign tracheobronchial strictures resistant to conventional balloon dilation, thus resulting in both technical and short-term clinical success rates of 100 %. The 6-month stenting group also exhibited a lower recurrence rate (41.7 vs. 83.3 %, P = 0.045) and a better mean maintained patency (39.7 ± 7.8 vs. 9.4 ± 5.4 months, P = 0.001) than the 2-month stenting group. We are not certain of the best time to remove a stent because it differs in each patient depending on the cause, duration, and severity of the strictures. However, when we removed a stent 6 months after its placement in a patient with a bronchial stricture resistant to balloon dilation, he had not experienced any complications at the end of the follow-up period (11 months). There were no significant immediate or delayed complications and no stricture recurrence after cutting balloon treatment during the follow-up period of 5 months. Cutting balloon dilation can be also a safe and effective therapeutic option for the treatment of benign bronchial strictures which are resistant to conventional balloon dilation. Kim et al. [30] reported that cutting dilation superior better patency, i.e., *60 % at 2 years, for the treatment of benign bronchial strictures resistant to conventional balloon dilation, as observed in the clinical outcomes of 11 patients who underwent cutting balloon treatment. Therefore, it is possible that temporary placement of a covered retrievable metallic stent or cutting balloon dilation may be appropriate for patients with RT-induced bronchial strictures resistant to conventional balloon dilation. Our study has a number of limitations that should be considered. First, it was nonrandomized and retrospective. Second, the small number of study patients may decrease the study’s statistical strength. In conclusion, fluoroscopically guided balloon dilation seems to be a safe and clinical effective for the treatment of RT-induced benign bronchial stricture. Temporary stent placement or cutting balloon dilation may be considered in patients with benign bronchial strictures resistant to fluoroscopically guided balloon dilation. Conflict of interest of interest.

The authors declare that they have no conflict

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Fluoroscopically guided balloon dilation for benign bronchial stricture occurring after radiotherapy in patients with lung cancer.

To evaluate the safety and clinical effectiveness of fluoroscopically guided balloon dilation in patients with benign bronchial stricture occurring af...
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