May 2012, VOLUME 198
NUMBER 5

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May 2012, Volume 198, Number 5

Vascular and Interventional Radiology

Original Research

Benign Anastomotic Strictures After Esophagectomy: Long-Term Effectiveness of Balloon Dilation and Factors Affecting Recurrence in 155 Patients

+ Affiliations:
1 The Johns Hopkins University School of Medicine, Baltimore, MD.

2 Department of Radiology and 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.

3 Department of Thoracic and Cardiovascular Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.

Citation: American Journal of Roentgenology. 2012;198: 1208-1213. 10.2214/AJR.11.7608

ABSTRACT
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OBJECTIVE. The purpose of this article is to retrospectively evaluate the long-term clinical results of balloon dilation in the treatment of benign anastomotic strictures after esophagectomy and to identify factors associated with stricture recurrence.

MATERIALS AND METHODS. From January 1996 to June 2011, a total of 309 sessions of balloon dilation were performed in 155 patients with benign anastomotic strictures after esophagectomy. Long-term clinical effectiveness was assessed using the following variables: technical and clinical success, complications, and patency rates. Factors independently related to recurrence were evaluated with the Cox model. Tested variables were age, sex, operation type, postoperative anastomotic leakage, balloon size, length of stricture, time to postoperative stricture development, complications, and neoadjuvant chemoradiotherapy.

RESULTS. The mean follow-up period was 37 months (range, 1–159 months). Overall clinical success was achieved in 153 patients (99%) after a single (n = 78) or multiple (n = 75) balloon dilations. During follow-up, recurrence of the stricture requiring repeated dilation was seen in 77 of 155 patients (50%). Esophageal rupture (mostly intramural rupture) occurred in 22 of 155 patients (14%) and 34 of 309 balloon dilations (11%). In multivariate analysis, early development of stricture within 10 weeks after surgery (p = 0.002) and McKeown esophagectomy (p = 0.002) were independently related to recurrence after initial balloon dilation.

CONCLUSION. Balloon dilation under fluoroscopic guidance has encouraging long-term results in the treatment of benign anastomotic strictures after esophagectomy. However, recurrence after balloon dilation was common, with McKeown esophagectomy and development of stricture within 10 weeks after surgery associated with recurrent strictures.

Keywords: balloon dilation, benign anastomotic stricture, esophagectomy

Fluoroscopically guided balloon dilation has been regarded as a safe and effective treatment for patients with benign anastomotic strictures of the upper gastrointestinal tract [1]. These benign strictures develop frequently when an esophagogastric anastomosis is performed after esophagectomy, with a mean prevalence rate of 30% (range, 9–48%) [28]. Furthermore, a proportion of patients with benign anastomotic strictures experience recurrent strictures requiring multiple therapeutic sessions [9]. Earlier reports have identified several risk factors for developing primary benign anastomotic strictures in general, including postoperative anastomotic leakage, poor vascularization of the gastric tube, a stapled rather than a handsewn anastomosis, and patients with preoperative cardiac disease and diabetes mellitus [10, 11]. However, the risk factors, prevalence, and clinical history of recurrent anastomotic strictures in patients complaining of dysphagia even after the initial treatment have been poorly delineated. In addition, few reports have yet explored the results of balloon dilation treatment for postoperative anastomotic esophageal strictures with a long-term follow-up period. Therefore, the aim of our retrospective study was to evaluate the long-term clinical results of balloon dilation for benign anastomotic strictures after esophagectomy and to identify factors associated with recurrence of strictures.

Materials and Methods
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Patient Population

Informed consent was obtained from each patient, and the study was approved by our institutional review board. Between January 1996 and June 2011, we performed fluoroscopically guided balloon dilation in 155 patients with benign anastomotic stricture after esophagectomy. These patients underwent either Ivor-Lewis (n = 117) or McKeown (n = 38) esophagectomy. The characteristics of the patient population in the current study are summarized in Table 1. They consisted of 148 men and seven women, and the age range was 16–93 years (mean, 63 years). The average interval between esophagectomy and the first session of balloon dilation was 9 months (median, 6 months; range, 6 weeks to 67 months). Esophagectomy was performed for esophageal cancer (n = 154) or traumatic esophageal rupture (n = 1).

TABLE 1: Characteristics of 155 Patients Who Underwent Balloon Dilation After Esophagectomy

Esophagography and endoscopy were performed within 2 weeks before balloon dilation to confirm the degree and location of the stricture. Participant criteria included patients with dysphagia from documented benign strictures diagnosed by endoscopic biopsy or clinical history, together with the findings of esophagography. The exclusion criteria were evidence of malignancy on endoscopic biopsy and tumor recurrence at the anastomosis site after balloon dilation. None of the 155 patients had a history of other management of anastomotic stricture, such as endoscopic dilation or bougienage. Twenty-seven patients had received both neoadjuvant radiation therapy and chemotherapy (n = 13), neoadjuvant radiation therapy alone (n = 11), or chemotherapy alone (n = 3).

Balloon Dilation Technique

The pharynx of each patient was topically anesthetized with an aerosol spray of lidocaine hydrochloride before balloon dilation. Neither sedation nor general anesthesia was used. The method used for balloon dilation has been described in detail elsewhere [12], and the summary is presented here. Under fluoroscopic guidance, a deflated balloon catheter (15–25 mm in diameter and 4–6 cm long; MAXILD, Cordis/Johnson & Johnson) was slowly inflated with diluted water-soluble contrast medium (iopromide; Ultravist 300, Schering Korea) until the hourglass deformity created by the stricture disappeared from the balloon contour or the patient developed severe pain (Figs. 1A, 1B, 1C, and 1D). The inflations were usually performed two or three times for 2–3 minutes in total. In cases of very severe strictures detected on esophagography, a small balloon catheter 10 or 12 mm in diameter was used first. If dilation with the first balloon catheter was easily accomplished and the patient tolerated the procedure well, the caliber of the balloon catheter was gradually increased to 20 mm at the same sitting. For patients with recurrent strictures that failed to resolve even after two or three sessions of balloon dilation with a 20-mm catheter, a 25-mm balloon catheter was used to treat the strictures if the patient could tolerate it. After balloon dilation, the patients swallowed water-soluble contrast medium to evaluate the presence of esophageal rupture.

The procedure was performed on an outpatient basis. If there were esophageal ruptures, we classified them into three types according to the movement of the leaked barium: type 1, intramural; type 2, transmural without mediastinal leakage; and type 3, transmural with mediastinal leakage [13]. When the natural drainage of leaked contrast medium back into the esophageal lumen (type 1 rupture) was not evident on the image, we allowed the patient to swallow 30–50 mL of saline to note washout of the leaked contrast medium. If leaked barium was not seen to be washed out after the patient swallowed saline, it was considered a type 2 rupture. Outpatients who had no mucosal tear or type 1 esophageal rupture were discharged after an observation period of 30 minutes. Patients with type 2 esophageal rupture were discharged with antibiotics (a combination of cephalosporins and amikacin) after an observation period of 30 minutes. If they reported no fever after 1 day, they stopped taking antibiotics. In case of fever, they were admitted. Patients with type 3 esophageal rupture were admitted to the hospital. Patients were allowed a soft diet 1 hour after completion of the procedure and were encouraged to resume intake of solid food the next day. All patients who underwent a balloon dilation treatment at our institution were advised to keep the head and upper body elevated during sleep to prevent reflux and not to eat for 2 hours before going to bed.

Follow-Up and Analysis of Data

All patients underwent esophagography 1 month after the procedure to verify the status of the stricture. Additional follow-up esophagography was performed only in patients with recurrent symptoms. If a patient had no difficulty swallowing solid food, further dilation was not performed. If a patient experienced dysphagia or if no improvement was noted on follow-up esophagography, repeat balloon dilation was performed. Final clinical information was later obtained by telephone from the patient or the patient’s physician to determine the final clinical results.

We evaluated technical success, clinical success, recurrence of dysphagia, primary and secondary patency rates, and complications related to the procedure. Technical success was defined by full obliteration of the hourglass deformity without a major complication, such as esophageal perforation or massive bleeding. Clinical success was considered to have been achieved if the patient did not report dysphagia after the procedure, without additional treatment until the last follow-up or death.

We defined recurrence as the reappearance of the patient’s symptoms of dysphagia and recurrent strictures as strictures that needed more than one session of balloon dilation to resolve the dysphagia. The primary patency period was defined as the time from balloon dilation until recurrence of dysphagia. The secondary patency period was defined as the total time from the first balloon dilation until recurrence of dysphagia after one or two additional sessions of balloon dilation undertaken because of primary recurrence. If multiple balloon catheters were used, the largest one was recorded as the balloon size.

Data processing and analysis were performed with SPSS software (version 18.0, SPSS). Patients lost to follow-up were censored at the date of the last observation or telephone interview. The patency curves after balloon dilation were created according to the Kaplan-Meier method and were compared with results of the log-rank test. Cox regression analysis was performed to assess factors related to recurrence after balloon dilation.

The following factors were included in a Cox univariate regression analysis of primary recurrence after balloon dilation: age, sex, operation type, postoperative anastomotic leakage, balloon size, length of stricture, time to postoperative stricture development, complications, and neoadjuvant chemoradiotherapy. In the multivariate analysis, we included factors that were significant or showed a trend toward statistical significance (p < 0.1) in the univariate analysis. Variables were selected in a stepwise forward selection manner, with entry and retention set with a two-sided p value of 0.05 considered to indicate a significant statistical difference.

Results
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Benign stricture was observed at the anastomotic site within a median time of 5 months after esophagectomy (mean, 7 months; range, 8 days to 36 months). All patients had a short stricture less than 1 cm at the esophagogastric anastomosis, except for five patients with a long stricture of 2.5–8 cm at the anastomotic site. The 155 patients in this study underwent a total of 309 sessions of balloon dilation, with a mean of 1.99 sessions per patient. The five patients with a long stricture all had undergone McKeown esophagectomy, and all except one showed recurrence after initial balloon dilation. They underwent a mean of 2.2 balloon dilation sessions during follow-up. We performed a single dilation in 78 patients (50%) and multiple dilations in 77 patients (50%). The follow-up period after the first balloon dilation was 1–159 months (mean, 37 months; median, 28 months). At the time this article was prepared, 91 patients were being followed, 62 patients had died of metastatic disease (n = 60) or pneumonia (n = 2), and two patients had been lost to follow-up.

Balloon dilation procedures were technically successful in all patients (100%). The clinical results are summarized in Table 2. Clinical success was achieved in 78 of the 155 patients (50%) after initial balloon dilation. As of the end of the follow-up period, these patients had not experienced symptomatic recurrence. The remaining 77 patients (50%) experienced recurrent dysphagia and underwent a second session of balloon dilation during the follow-up period. The time interval between the first and second dilation procedures ranged from 8 days to 39 months (mean, 5 months; median, 2 months). A total of 151 sessions of additional balloon dilation were performed in 77 patients because of recurrence (mean, 2 sessions; range, 1–8 sessions). Fifty-eight patients (37%) had no recurrence after one (n = 44) or two (n = 14) additional balloon dilation sessions. Seventeen patients (11%) underwent three or more additional balloon dilation procedures until recurrent dysphagia resolved. One patient had recurrent dysphagia and died of pneumonia 1 month after the second session of balloon dilation. Another patient had a 6-cm-long diffuse stricture and received temporary placement of a covered retrievable stent (16-mm diameter) for 2 months (Figs. 2A, 2B, 2C, and 2D). Thus, overall clinical success was achieved in 153 patients (99%) after a single (n = 78) or multiple (n = 75) balloon dilations.

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Fig. 1A65-year-old man treated with McKeown esophagectomy and esophagogastrostomy.

A, Image shows stricture (arrow) at anastomosis.

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Fig. 1B65-year-old man treated with McKeown esophagectomy and esophagogastrostomy.

B, Balloon (20 mm in diameter) was placed and inflated until hourglass deformity (arrow, B) disappeared (arrow, C).

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Fig. 1C65-year-old man treated with McKeown esophagectomy and esophagogastrostomy.

C, Balloon (20 mm in diameter) was placed and inflated until hourglass deformity (arrow, B) disappeared (arrow, C).

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Fig. 1D65-year-old man treated with McKeown esophagectomy and esophagogastrostomy.

D, Esophagography performed immediately after balloon dilation shows improvement of luminal diameter (arrow) without rupture.

The maximum diameter of the balloon used in the initial dilation was 20 mm in 138 patients, 18 mm in seven patients, 16 mm in two patients, and 15 mm in eight patients. In subsequent balloon dilation sessions, a 25-mm-diameter balloon was used in 13 patients whose dysphagia failed to resolve even after two or three sessions of balloon dilation with a 20-mm catheter. In the rest of the patients, a balloon with a diameter up to 20 mm was used to manage recurrent strictures.

TABLE 2: Clinical Results of Fluoroscopically Guided Balloon Dilation in 155 Patients With Benign Anastomotic Stricture After Esophagectomy

No treatment-related deaths occurred in this series. Esophageal rupture occurred in 22 of 155 patients (14%) and 34 of 309 balloon dilations (11%): there were 32 type 1 and two type 2 ruptures. After the first balloon dilation session, 15 patients developed type 1 rupture and none developed type 2 rupture. No one showed fever or had major complications requiring further treatment or surgery.

TABLE 3: Risk Factors for Recurrence of Benign Anastomotic Strictures After Esophagectomy

Primary and secondary patency curves are shown in Figure 3. The primary patency rates at 1, 3, and 6 months and 1, 2, 3, and 5 years were 88%, 67%, 59%, 52%, 49%, 45%, and 43%, respectively. Secondary patency rates at 1, 3, and 6 months and 1, 2, 3, and 5 years were 98%, 92%, 86%, 82%, 79%, 75%, and 74%, respectively.

Results of univariate and multivariate analysis of risk factors for developing recurrent strictures (defined beforehand as requiring > 1 balloon dilation session) are shown in Table 3. The following p values less than 0.1 on Cox univariate regression analysis were entered into the multivariate Cox proportional-hazards model: operation type (p = 0.001), stricture diagnosed within 10 weeks after surgery (p = 0.006), esophageal rupture (p = 0.072), and length of stricture (p = 0.032). In the proportional-hazards model, only early development of stricture within 10 weeks after surgery (odds ratio [OR], 2.39; p = 0.002) and McKeown esophagectomy (OR, 2.35; p = 0.002) were significant risk factors for recurrent strictures.

Discussion
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Balloon dilation has become a widely used nonsurgical method of managing anastomotic strictures after esophagectomy [14]. Although it is associated with high clinical success, balloon dilation is reported to require repeated dilations to successfully treat benign anastomotic strictures [12]. Despite this fact, few studies have yet explored the factors associated with a recurrent stricture necessitating multiple dilation sessions.

In this study, 78 of 155 patients (50%) required only a single dilation procedure. Approximately half the patients were found to have developed recurrence requiring repeated balloon dilations, and 58 patients (37%) experienced no recurrence after one (n = 44) or two (n = 14) additional balloon dilation sessions after the initial balloon dilation failed to resolve recurrent stricture. Balloon dilation achieved long-term stricture resolution and concomitant clinical resolution of symptoms after one to three trials in 136 patients (88%). The overall clinical success rate with balloon dilation was 99%, consistent with other rates reported in the literature, ranging from 83% to 100% [1518].

The multivariate Cox regression analysis showed that the early development of stricture within 10 weeks after surgery and McKeown esophagectomy were independently related to recurrence after initial balloon dilation. Patients who developed a benign anastomotic stricture within 10 weeks after esophagectomy were more than twice as likely to experience frequent recurrence requiring multiple balloon dilations as those who developed a stricture later than 10 weeks after surgery (OR, 2.39; p = 0.002). Considering that anastomotic stricture in the early postoperative period is due to wound healing [19], there might be differences in the “aggressiveness” of scar tissue formation leading to high resistance to balloon dilation [11].

A statistically significant correlation was also found between surgical techniques for esophagectomy (e.g., Ivor-Lewis or McKeown) and the development of recurrent anastomotic stricture. The McKeown esophagectomy is similar to the Ivor-Lewis esophagectomy except that the anastomosis is created in the neck through a separate cervicotomy rather than via intrathoracic anastomosis [19]. Patients who underwent a McKeown esophagectomy were more prone to recurrences after balloon dilation than were those who had an Ivor-Lewis esophagectomy (OR, 2.35; p = 0.002). Twenty-five of 38 patients (66%) developed a recurrent stricture, compared with 52 of 117 (44%) patients who underwent an Ivor-Lewis esophagectomy. This difference in recurrence rate might be partly explained by the findings of Levy et al. [20], who reported that anastomotic leak and stricture have been shown to occur with increased frequency in patients with McKeown esophagectomy compared with the Ivor-Lewis approach. Anastomotic leak can cause fistula formation with adjacent anatomic structures, and patients who develop anastomotic leaks have a higher chance of eventual stricture formation [21, 22]. Another possible explanation for the higher recurrence rate seen in patients with McKeown esophagectomy might be related to the difference in the location where the anastomosis is created during surgery. The gastric tube is pulled up higher in the cervical esophagus to form the anastomosis during the McKeown surgery compared with the Ivor-Lewis surgery [19]. This maneuver might have contributed to poorer vascularization of the gastric tube at the anastomotic site, which is known to be a risk factor for developing postoperative anastomotic strictures [10].

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Fig. 2A65-year-old man with long stricture after McKeown esophagectomy.

A, Barium esophagography performed before dilation shows 6-cm-long stricture (arrows) in esophagus.

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Fig. 2B65-year-old man with long stricture after McKeown esophagectomy.

B, Partially inflated balloon (arrows) shows stricture in esophagus.

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Fig. 2C65-year-old man with long stricture after McKeown esophagectomy.

C, After second session of balloon dilation, 16-mm covered retrievable stent (arrows) was placed over stricture site.

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Fig. 2D65-year-old man with long stricture after McKeown esophagectomy.

D, Follow-up esophagogram with stent removed 2 months after stent placement shows resolution of stricture (arrows).

Although the length of the stricture did not show a statistically significant correlation with recurrence in the multivariate model, it was a statistically significant factor in the univariate model (OR, 3.03; p = 0.032). Five patients in this study had a long stricture and all except one showed recurrence after the initial balloon dilation. The mean number of balloon dilations in these patients was greater than that of the entire study population. It was previously reported that short strictures smaller than 1.2 cm showed better responses to balloon dilation than did long strictures and that the number of repeat dilations was correlated with the length of the stricture [16]. A larger sample size of patients with a long stricture might be needed to show similar results in our multivariate analysis.

Balloon size had no significant correlation with symptomatic recurrence in the Cox model. A separate chi-square test also revealed that balloon size and complications such as esophageal rupture were not statistically correlated in our study (p = 0.671). In most patients, we used a balloon with a 20-mm diameter during the initial dilation session. Only 17 patients (11%) were treated with a balloon with a diameter less than 20 mm because we did not proceed to use a larger balloon when the patient reported severe pain. Considering that there was no significant statistical association between balloon size and symptomatic recurrence in our study, a 20-mm balloon seems to be a desirable size for achieving successful dilation of anastomosis provided that the patient can tolerate it, because most patients were treated with a 20-mm balloon with no major complications.

The use of stents has rarely been indicated for the management of benign gastrointestinal strictures when the long-term survival of the patient is likely because of the high rates of complications caused by stent placement, including perforation, esophageal ulceration, and stent migration [23, 24]. However, temporary placement of covered retrievable stents has been reported to be effective for patients who show resistance to balloon dilation [14]. Kim et al. [25] proposed that temporary stenting be considered for patients with a postoperative anastomotic stricture less than 7 cm that showed elastic recoil phenomenon after balloon dilation or severe stenosis precluding an adequate balloon at the anastomotic site. One of our study patients had a 6-cm-long diffuse stricture refractory to balloon dilations. We placed a covered retrievable stent across the stricture for 2 months. After removal of the stent, the stricture became widely patent and the patient did not report any dysphagia.

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Fig. 3 Kaplan-Meier plot shows primary (black hashmarks and line) and secondary (gray hashmarks and line) patency rates for 155 patients who underwent balloon dilation.

The principal limitation of this study is its retrospective and nonrandomized design, which could introduce some bias and decrease the study’s statistical strength.

In conclusion, fluoroscopically guided balloon dilation is a well-standardized and a technically easy modality for the treatment of benign anastomotic stricture after esophagectomy. Balloon dilation is associated with a low complication rate and yields a high clinical success rate after only a few sessions in most patients. However, the recurrence rate after initial balloon dilation is rather high, with McKeown esophagectomy and early development of stricture within 10 weeks after surgery associated with repeated balloon dilation.

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Address correspondence to H. Y. Song ().

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