Usefulness of intralesional triamcinolone in treatment of benign esophageal strictures

Usefulness of intralesional triamcinolone in treatment of benign esophageal strictures Rakesh Kochhar MD, DM, Govind K. Makharia MD, DM, DNB Chandigarh, India

Introduction: The cornerstone treatment for benign esophageal strictures is endoscopic dilation. There are reports suggesting that intralesional corticosteroid injection decreases the frequency of endoscopic dilation. Methods: Seventy-one patients (mean age 42.39 [17.52] years; range, 13-78 years) with benign esophageal strictures (corrosive 29, peptic 14, anastomotic 19, radiation-induced 9) were recruited for this study. All were being managed with a program of intermittent endoscopic dilation by using over-the-wire polyvinyl dilators. All patients were treated by intralesional injections of triamcinolone acetonide (40 mg/mL diluted 1:1 with saline solution) by using a 23-gauge, 5-mm long sclerotherapy needle in aliquots of 0.5 mL. At each session, 4 injections (4 quadrants) were made at the proximal margin of the stricture with another 4 injections into the strictured segment itself whenever possible. The intervals between dilations and frequency of dilations were calculated before and after triamcinolone injections. A periodic dilation index (defined as number of dilations required per month) before and after the triamcinolone injections was calculated. Results: The overall mean (SD) duration of treatment before intralesional injection was 10.9 (19.8) months (range, 1-120 months) and the mean number (SD) of esophageal dilations required was 9.67 (13.06) (range, 1-70). The mean number of sessions of intralesional injection was 1.4 (0.62). After initiation of intralesional injections mean follow-up was 8.1 (5.6) months (range 3-30 months) and the mean number of esophageal dilations was 3.8 (3.0) (range 0-16). The periodic dilation index decreased significantly from 1.24 (0.05) (range 0.13-3.16) before injection to 0.5 (0.33) (range, 0-2) after injection (p < 0.001). For each category of stricture, the periodic dilation index decreased significantly: corrosive, 1.24 (0.5) to 0.53 (0.34) (p < 0.001); peptic, 0.92 (0.44) to 0.42 (0.2) (p < 0.001); anastomotic, 1.24 (0.49) to 0.51 (0.4) (p < 0.001); and radiation-induced, 1.32 (0.6) to 0.6 (0.3) (p < 0.02). Conclusion: Intralesional injections of triamcinolone augment the effects of dilation in patients with benign esophageal strictures. (Gastrointest Endosc 2002;56:829-34.)

Etiologically, benign esophageal strictures are classified as peptic, corrosive-induced, anastomotic, radiation-induced, and drug-induced.1-6 Although peptic strictures predominate (68%-86%) in the United States3 and Europe,4 corrosive injury accounts for 42% to 60% of strictures in India.2,5,7 Management consists of control of acid reflux (for peptic strictures)8 and periodic esophageal dilation.9 Although most peptic strictures respond to antireflux treatment and usually do not require more than one session of esophageal dilatation, repeated dilation is Received February 14, 2002. For revision May 24, 2002. Accepted August 21, 2002. Current affiliations: Department of Gastroenterology, Postgraduate Institute of Medical Education and Research, Chandigarh, India. Presented in part at Digestive Diseases Week and the annual meeting of American Gastroenterological Association, May 21-24, 2000, San Diego, California (Gastroenterology 2000;18(Suppl 2):A243. Reprint requests: Rakesh Kochhar, MD, Additional Professor, Department of Gastroenterology, Postgraduate Institute of Medical Education and Research, Chandigarh-160012, India. Copyright © 2002 by the American Society for Gastrointestinal Endoscopy 0016-5107/2002/$35.00 + 0 37/1/129871 doi:10.1067/mge.2002.129871 VOLUME 56, NO. 6, 2002

nevertheless required for some patients.3,4 As compared with peptic strictures, corrosive strictures may be long, tortuous, and even multiple.5,10 By comparison, these require more esophageal dilation sessions and are more likely to recur.5,10 The natural history of radiation-induced and anastomotic esophageal strictures has not been studied to a great extent.11 Among therapeutic options for augmentation of the effects of endoscopic dilation, one novel technique is intralesional injection of corticosteroids.12-15 Although evidence of the effectiveness of injection of corticosteroids into benign esophageal strictures was first reported by Ashcraft and Holder16 in 1969, this therapy was used only occasionally during the 1970s and 1980s.16-19 However, over the last decade there has been growing interest in the use of this form of therapy for refractory benign esophageal strictures.12-15,20,21 In a study of patients with corrosive-induced strictures, a significant decrease was found in the periodic dilation index (esophageal dilations required per month) when intralesional corticosteroid injections were combined with esophageal dilation.15 The aim of the present study was to determine whether intralesional corticosteroid GASTROINTESTINAL ENDOSCOPY

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Table 1. Characteristics of 71 patients with esophageal strictures of differing etiology Characteristics Age (y) Mean (SD) Range Gender (M:F) Site of stricture(s) Proximal third Mid third Distal third No. of strictures One Two Three No. of patients with length of stricture <3 cm ≥3 cm Mean diameter of stricture (mm) (SD)

Corrosive (n = 29)

Peptic (n = 14)

Anastomotic (n = 19)

After radiation (n = 9)

Total (n = 71)

29.3 (8.6) 13-53 14:15

53.5 (19.5) 16-78 10:4

50.0 (16.8) 19-73 11:8

51.0 (10.4) 32-65 5:4

42.3 (17.5) 13-78 40:31

14 (19.7%) 12 (16.9%) 3 (4.2%)

— — 14 (19.7%)

19 (26.76%) — —

— 6 (8.45%) 3 (4.23%)

33 (46.48%) 18 (25.35%) 18 (28.17%)

18 (25.35%) 10 (14.08%) 1 (1.4%)

14 (19.71%) — —

19 (26.76%) — —

9 (10.68%) — —

60 (85.4%) 10 (14.08%) 1 (1.4%)

19 (26.76%) 10 (14.08%) 6.68 (1.25)

14 (19.71%) — 7.35 (1.49)

19 (26.76%) — 5.89 (0.73)

9 (10.68%) — 8.22 (0.83)

61 (85.91%) 10 (14.08%) 6.80 (1.34)

injections decrease the need for subsequent dilation of esophageal strictures of differing etiologies. PATIENTS AND METHODS The study group was comprised by 71 patients (40 men, 31 women; mean age [SD] 42.39 [17.52] years; range, 13-78 years) with benign esophageal strictures of differing etiologies treated between June 1995 to May 2000. All had significant dysphagia and required esophageal dilation on a regular basis. The esophageal strictures were characterized by barium contrast radiography and upper endoscopy. Stricture diameter was measured on radiographs with adjustments for magnification. The site(s), length(s), and number(s) of stricture(s) were recorded for each patient. In those with radiation-induced and anastomotic strictures (after transhiatal esophagectomy for carcinoma of the esophagus), multiple biopsy specimens were taken from the stricture to exclude recurrent malignancy. Patients with peptic strictures were advised to adhere to antireflux measures and treated with proton pump inhibitors. Eight of the 17 patients who participated in a previous study15 were included among the 29 patients with corrosiveinduced strictures in the present study. This was done because the length of follow-up had been extended for these 8 patients. Exclusions criteria were pharyngeal stenosis precluding endoscopic examination and dilation, tracheoesophageal fistula, and gastric cicatrization that precluded safe placement of a guidewire. The study was approved by the ethics committee of our institution. Informed consent was obtained from each patient. Before endoscopic esophageal dilation, patients were sedated by intravenous administration of midazolam (30 µg/kg). Intralesional injections of corticosteroid were preceded by intravenous administration of 20-40 mg of hyoscine-n-butyl-bromide (Buscopan, German Remedies, Goa, India). Triamcinolone acetonide (40 mg/mL diluted 1:1 with saline solution) Kenacort, Squibb, Vadodra, India) was injected with a 23-gauge, 5-mm long sclerotherapy 830

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needle (3MK; Olympus Optical Co., Tokyo, Japan) in aliquots of 0.5 mL. At each injection session, a total of 4 injections were made at the proximal margin of the stricture in quadrants, and another 4 injections were made into the strictured segment whenever possible. In 63 (88.7%) patients, intralesional injections were made just before dilation, whereas the remaining 8 patients underwent injections 2 hours after dilation because the stricture was located in the postcricoid region (n = 4) or a tortuous stricture with an obliquely placed opening (n = 4) prevented optimal positioning of the endoscope. If at the subsequent scheduled dilation procedure there was no subjective improvement in dysphagia, injections were repeated, the maximum number of sessions in any patient being 4. Endoscopic dilation was performed by wire-guided passage of Savary-Gilliard dilators (Wilson-Cook Medical Inc., Winston-Salem, N.C.) at intervals of 3 weeks until a 15-mm diameter dilator could be passed. Subsequently, dilation was performed on an “on-demand” basis. Fluoroscopic guidance was used during the first dilation in each patient and subsequently whenever guidewire passage was believed to be “not smooth.” At each visit, patients were interrogated as to severity of dysphagia, which was graded on a scale of 0 to 4 (grade 0, no dysphagia; grade 1, dysphagia with ingestion of solid food; grade 2, dysphagia to semisolid food, grade 3, dysphagia to liquids; grade 4, aphagia). After each dilation patients were observed for 4 hours with specific attention to the occurrence of chest pain, abdominal pain, and difficulty in breathing and hemodynamic status. Patients were discharged home the same day with instructions to immediately report the development of fever, chest pain, or shortness of breath. To assess the effect of intralesional triamcinolone injection on requirement for esophageal dilation, a periodic dilation index (PDI) was calculated as the number of dilations required/duration of time in months.15 The PDI was calculated from the time of the first dilation to the first intralesional triamcinolone injection and from that point until the last follow-up assessment. VOLUME 56, NO. 6, 2002

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Table 2. Effects of intralesional triamcinolone injections on esophageal dilation (n = 71) Variables No. of dilations Before injection Mean Range After injection Mean Range Total duration (mo) Before injection Mean Range After injection Mean Range Periodic dilation index Before injection Mean Range After injection Mean Range No. of patients in whom stricture could be dilated to 15 mm Before injection After injection Maximum dilation (mm) Before injection Mean (SD) Range After injection Mean (SD) Range

Corrosive (n = 29)

Peptic (n = 14)

Anastomotic (n = 19)

After radiation (n = 9)

Total (n = 71)

16.72 (18.04) 1-70

3.58 (1.29) 2-6

4.84 (3.3) 2-15

6.22 (4.17) 2-13

9.67 (13.06) 1-70

4.6 (3.04)* 1-14

2.71 (1.43)* 0-6

3.73 (3.7)* 0-16

3.66 (2.78)* 0-10

3.88 (3.0)* 0-16

17.7 (28.7) 1-120

6.5 (6.6) 2-24

5.3 (6.6) 1-30

8.0 (8.8) 1-25

10.9 (19.8) 1-120

10.6 (7.2) 3-30

6.5 (2.7) 3-12

7.2 (3.9) 4-20

4.4 (2) 3-8

8.13 (5.6) 3-30

1.37 (0.62) 0.5-3.16

0.92 (0.44) 0.16-1.66

1.24 (0.49) 0.13-2

1.32 (0.6) 0-2

1.24 (0.5) 0.13-3.16

0.53 (0.34)* 0.1-1.33

0.42 (0.2)* 0-0.75

0.51 (0.4)* 0-2

0.6 (0.3)* 0-1

0.51 (0.33)* 0-2

12 26

8 13

8 17

3 8

31 64

13.28 (1.15) 11-15

14.08 (0.94) 12.8-15

13.23 (1.42) 11-15

13.91 (1.1) 12.8-15

13.49 (1.22) 11-15

14.93 (0.7)* 14-17

14.85 (0.36)* 14-15

14.73 (0.45)* 14-15

14.64 (0.76)* 12.8-15

14.82 (0.59)* 12.8-17

*Statistically significant (p < 0.05), Student t test.

Data were analyzed by using the Student paired t test and analysis of variance. The Student t test was applied to assess the level of change within the group between preinjection and postinjection PDIs. Analysis of variance was applied to assess differences in PDI among the 4 etiologic categories for benign esophageal strictures. Unless otherwise noted, data are expressed as mean (1 standard deviation).

RESULTS The etiologies of the esophageal strictures were as follows: corrosive ingestion (n = 29), peptic (n = 14), anastomotic (n = 19), and radiation-induced (n = 9). Stricture locations were as follows: proximal esophagus, 46.4%; mid esophagus, 25.3%; and distal esophagus, 28.1%. All anastomotic strictures were located in the proximal esophagus whereas all peptic strictures were confined to the distal esophagus. Corrosive-induced strictures characteristically involved all 3 segments of the esophagus (41 strictures in 19 patients) (Table 1). All peptic, anastomotic, and radiation-induced strictures were less than 3 cm long, whereas 10 (14.08%) of the 41 VOLUME 56, NO. 6, 2002

corrosive induced strictures were between 3 and 6 cm in length. Peptic, anastomotic, and radiationinduced strictures characteristically were solitary, whereas 11 (15.48%) of 29 patients in the corrosive-induced category had multiple strictures (Table 1). Intralesional triamcinolone injection was successful and esophageal dilations uneventful in all patients. The mean number of sessions of intralesional injections was 1.4 (0.6) (range 1-4). Forty-four (61.9%) patients underwent 1 session, 25 (35.3%) 2 sessions, 1 (1.4%) 3 sessions, and 1 (1.4%) 4 sessions of intralesional triamcinolone injection. No complications developed as a result of intralesional injections or esophageal dilation. The mean number of dilations before intralesional injections for all patients was 9.67 (13.06) (range, 170), which were performed over a mean period of 10.9 (19.8) months (range, 1-120 months). After initiation of intralesional injections the mean number of dilations was 3.88 (3.0) (range, 0-16) over a mean period of 8.1 (5.6) months (range, 3-30 months) (Table 2). GASTROINTESTINAL ENDOSCOPY

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Table 3. Grade of dysphagia and effect of endoscopic dilation and intralesional triamcinolone injection Grade of dysphagia Etiology

Figure 1. Periodic dilation index (number of dilations required/duration in months) before and after intralesional triamcinolone injection in 4 etiologic groups.

Overall, the PDI changed significantly from 1.24 (0.5) (range 0.13-3.16) to 0.51 (0.33) (range, 0-2) (p < 0.001) (Table 2). For all etiologic categories of stricture, there was a significant change when the PDI before was compared with the PDI after initiation of corticosteroid injections: corrosive-induced, 1.37 (0.62) to 0.53 (0.34) (p < 0.001); peptic, 0.92 (0.44) to 0.42 (0.2) (p < 0.001); anastomotic, 1.24 (0.49) to 0.51 (0.4) (p < 0.001); radiation-induced, 1.32 (0.6) to 0.6 (0.3) (p < 0.02) (Fig. 1). When the effect of intralesional corticosteroids on PDI was compared between different etiologic categories, no significant difference was observed. Dysphagia score decreased significantly after stricture dilation in each of the 4 etiologic groups, and there was a further decrease after initiation of intralesional triamcinolone injections (Table 3). Mean maximum esophageal dilation achieved before injection was 13.49 (1.22) mm, which increased significantly to 14.8 (0.59) mm (p < 0.01). Overall, in 31 (43.6%) of the 71 patients, the maximum diameter achieved increased after beginning intralesional triamcinolone injections (Table 2). The length, number, and location of strictures did not have any significant effect on the PDI. DISCUSSION The preferred mode of treatment of benign esophageal strictures is endoscopic dilation with either a bougie or a balloon.2,10 Most peptic strictures respond to treatment with acid suppressive drugs and require a single session of endoscopic dilation, but some patients have intractable strictures.20 Strictures from other causes often require repeated sessions of endoscopic dilation.2,4-10,13-15 Corrosive-induced strictures require more endoscopic dilation sessions compared with peptic strictures, and the treatment of patients with the former type is often prolonged.2,5-7,10,15 Radiation-induced strictures also fall in the category of treatmentresistant.11 There are few data on anastomotic 832

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Before dilation

Corrosive (n = 29) 2.89 (0.4) Peptic (n = 14) 2.78 (0.42) Anastomotic (n = 19) 3.1 (0.31) After radiation (n = 9) 3.0 (0.5) Total (n = 71) 2.94 (0.41)

Before injection 2.34 1.85 2.42 2.44 2.28

(0.55)* (0.36)* (0.5)* (0.52)* (0.53)*

After injection 0.65 0.28 0.63 1.22 0.64

(0.61)† (0.46)† (0.59)† (0.44)† (0.61)†

*Significant difference from before dilation to before corticosteroid injections in dysphagia score (p = 0.001), Student t test. †Significant difference from before corticosteroid injections to after injection dysphagia score (p = 0.001), Student t test.

strictures.2 Attempts to improve the results of endoscopic dilation include endoscopic stricture incision, treatment with Nd:YAG laser,22 prosthesis placement,23 and intralesional injection of corticosteroids.13-15 The results of the present study demonstrate that the frequency of dilation, as assessed by PDI, decreased after corticosteroid injection(s) in all etiologic groups of esophageal strictures. Mean maximum diameter of the strictures, as assessed by the largest dilator passed, increased significantly from 13.49 (1.22) mm before corticosteroid injections to 14.82 (0.59) mm after initiation of injections in 71 patients. In addition, the response was consistent across all etiologic groups (Table 2). These observations support the contention that corticosteroid injections help to alleviate dysphagia, either by maintaining luminal diameter or by enhancing the response to concomitant dilation. The location, number, and length of the strictures did not influence efficacy of the treatment: results were similar for strictures in the proximal (46.48%), mid (25.3%), and distal (28.1%) esophagus, for short (<3 cm) as opposed to long (>3 cm) strictures, and for single versus multiple strictures. It is possible that the decrease in PDI noted after intralesional corticosteroid injections may actually be due to a gradual opening of the stricture in response to repeated dilations. To eliminate this potential bias inherent in a longitudinal study, the mean PDI calculated after intralesional corticosteroid injections was compared with the mean PDI calculated for the entire period starting from the first dilation onward. The former was found to be significantly less (p < 0.01) for all 4 etiologic groups, thus discounting the possibility of bias. A significant decrease in mean dysphagia score was observed in the postinjection period (Table 3). As expected, there was a decrease in mean dysphagia score with dilation alone before intralesional corticosteroid injections. VOLUME 56, NO. 6, 2002

Benign esophageal strictures: intralesional triamcinolone

Ideally, the assessment of the efficacy of intralesional corticosteroid injections would require a randomized controlled trial in which patients in one study arm would undergo injections together with dilation whereas patients in the other would have only esophageal dilation. A report of one such study has been published in abstract form.24 In that study of patients with peptic strictures, those receiving a combination of intralesional corticosteroid injection and endoscopic dilation had a PDI of 0.065, as compared with a PDI of 0.255 in those who underwent endoscopic dilations alone. Triamcinolone acetate or acetonide in concentrations of 10 mg/mL has been used in most studies of intralesional corticosteroid injection,13-15 although Gandhi et al.19 used a concentration of 40 mg/mL. The volume per injection has varied from 0.6 mL to 2.8 mL. In the present study, 40 to 100 mg (i.e., 1.0 to 2.5 mL of 40 mg/mL) of triamcinolone acetonide was injected per session. Patients underwent 1 to 4 injection sessions (mean 1.4 [0.6]). The criterion used to determine whether further injections were needed was the subjective response of the patient; if improvement was reported at subsequently scheduled sessions, no further injections were given. It is possible that additional injections, irrespective of response, might have further decreased the subsequent requirement for dilation. Response to corticosteroid injections in different series has not been uniform, with some patients failing to respond even after multiple injections. This could be due to improper localization of the injections. Bhutani et al.21 suggested the use of an EUS catheter probe to guide the injection into the thickest portion of the stricture. The exact mechanism(s) whereby intralesional corticosteroid injections reduce the need for dilation of esophageal strictures is unknown. The efficacy of corticosteroid injections in the treatment of dermatologic scars, such as keloids and burn scars, is well established.25,26 Based on results in an experimental study, Ashcraft and Holder16 suggested that intralesional corticosteroids inhibit not only collagen synthesis, but also fibrosis and chronic scarring, thereby inhibiting the formation of a stricture. It has also been suggested that triamcinolone prevents the cross linking of collagen that results in scar contracture.27 There are isolated case reports in which intralesional corticosteroids injection is described as effective treatment for strictures in different sites such as the subglottic region,28 urethra,29-31 and pylorus.32 No complication related to intralesional corticosteroids injection(s) was encountered in any of our patients. Theoretically, there is a potential for VOLUME 56, NO. 6, 2002

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esophageal perforation and mediastinitis or pleural effusion. The only reported esophageal perforation occurred in a series of patients in whom a rigid endoscope was used.18 There could also be a risk of esophageal candidiasis inasmuch as there is a great propensity for this to occur in stenotic esophageal lesions; local corticosteroid injections could further increase this risk. In our initial experience, patients were routinely treated with antifungal agents as a prophylactic measure before intralesional corticosteroid injections, but this practice has been discontinued. In conclusion, intralesional corticosteroid injections augmented the effects of endoscopic dilation in all forms of benign esophageal strictures studied. This intervention is safe and has not been associated with any complication. REFERENCES 1. Miller LS, Jackson W, McCray W, Chung CY. Benign nonpeptic esophageal strictures: diagnosis and treatment. Gastrointest Endosc Clin N Am 1998;8:329-55. 2. Kochhar R, Makharia GK. Endoscopic therapy of benign esophageal strictures. In: Bhutani M, Tandon RK, editors. Advances in gastrointestinal endoscopy. New Delhi: Jaypee Brothers; 2001. p. 57-85. 3. Patterson DJ, Graham DY, Smith JL, Schwartz JT, Alpert E, Lanza FL, et al. Natural history of benign esophageal stricture treated by dilation. Gastroenterology 1983;89:346-50. 4. Williamson RCN. The management of peptic esophageal stricture. Br J Surg 1975;62:448-54. 5. Broor SL, Kumar A, Chari ST, Singal A, Misra SP, Kumar N, et al. Corrosive esophageal strictures following acid ingestion: clinical profile results of endoscopic dilatation. J Gastroenterol Hepatol 1989;4:56-61. 6. Zargar SA, Kochhar R, Nagi B, Mehta S, Mehta SK. Ingestion of corrosive acids. Spectrum of injury to upper gastrointestinal tract and natural history. Gastroenterology 1989;97:702-7. 7. Zargar SA, Kochhar R, Nagi B, Mehta S, Mehta SK. Ingestion of strong corrosive alkalis : spectrum of injury to upper gastrointestinal tract and natural history. Am J Gastroenterol 1992;87:337-44. 8. Marks RD, Richter JE. Peptic strictures of the esophagus. Am J Gastroenterol 1993;88:1160-73. 9. American Society of Gastrointestinal Endoscopy. Esophageal dilation. Guidelines for clinical application. Gastrointest Endosc 1991;37:122-4. 10. Broor SL, Raju GS, Bose PP, Lahoti D, Ramesh GN, Kumar A, et al. Long term results of endoscopic dilatation for corrosive esophageal strictures. Gut 1993;34:1498-501. 11. Swaroop VS, Desai DC, Mohandas KM, Dhir V, Dave UR, Gulla RI, et al. Dilation of esophageal stricture induced by radiation therapy for cancer of the esophagus. Gastrointest Endosc 1994;40:311-5. 12. Berenson GA, Wyllie R, Caulfield M, Steffen R. Intralesional steroids in the treatment of refractory esophageal strictures J Pediatr Gastroenterol Nutr 1994;18:250-2. 13. Lee M, Kubik CM, Polhamus CD, Brady CD, Kadakia SE. Preliminary experience with endoscopic intralesional steroid injection therapy for refractory upper gastrointestinal strictures. Gastrointest Endosc 1995;41:598-601. 14. Zein MN, Greseth JM, Perrault J. Endoscopic intralesional GASTROINTESTINAL ENDOSCOPY

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