III.2.1. Endoscopic balloon dilation in inflammatory bowel disease

Dr. Fernando Muñoz Núñez
Hospital Universitario de León

 

INTRODUCTION

The development of stenoses in Crohn’s disease (CD) is a common complication that occurs in up to 30% of patients with the diagnosis1-3. Moreover, in 27% patients with initially uncomplicated CD, the phenotype eventually evolves into stenosing forms after 10 years2 (Fig. 1). The appearance of stenosis is associated with an increased risk of requiring immunosuppressants and especially surgery in up to 90% of cases4. Stenoses are the most common reason for bowel resection in CD5, with the aggravating factors of the high probability of recurrence, and the need for two or more surgeries during the course of the disease in up to 9–13% of cases3,6. In fact, CD is one of the most common causes of short bowel syndrome 7, hence the need to search for alternatives to bowel resection and strictureplasty, with excellent results similar to those of resection in terms of clinical recurrence8. Thus, it makes sense to resort to approaches such as endoscopic dilation, which aims to reopen the intestinal lumen without the need to resect the stenotic area.

 
FIGURA 1. Comportamiento de la EC con el tiempo2.

 

INITIAL ASSESSMENT OF STENOSES. FACTORS TO CONSIDER IN THE THERAPEUTIC DECISION

The first important factor to consider when treating a stenosis in a patient with inflammatory bowel disease (IBD) is whether it is causing symptoms, usually of the subocclusive kind. If the stricture is asymptomatic, the risk-benefit ratio is probably not propitious to dilation, as the procedure is associated with complications, without any apparent benefit. This is distinct from the decision of whether or not to step up medical treatment, as this is a complicated disease. Secondly, the information obtained by endoscopy must be complemented by other imaging techniques, usually magnetic resonance enterography (MR enterography) or computerised tomography enterography (CT enterography), allowing us to identify the characteristics of the stenoses including their length, number, concomitant activity, the presence of fistulas or abscesses, their nature, etc.

The different factors that can influence the decision of whether or not to dilate are:

Location of the stenosis. Most stenoses in CD are located in the distal ileum (90%): 5–17% in the colon, and a small percentage (1–5%) in proximal regions; perhaps due to their implications, duodenal ones are especially worthy of mention9. As a result, in most cases, stenoses can be reached using conventional endoscopes in order to perform endoscopic dilation. Non-accessible lesions can be successfully tackled with different types of enteroscopes10,11. More than difficulty of access, the presence of distinct angulation can hinder this approach and limit its effectiveness, which is why it is not usually recommended in these cases12.

Two locations in particular are propitious to endoscopic dilation: doudenal and ileoanal pouch stenoses. In the case of duodenal stenoses, this is due to their marked clinical impact and the difficulties involved in their surgical resection, which reduce the possibility of strictureplasty or diversion. While there is currently very limited experience with dilation at this location, and despite the small number of series and cases included therein13-15, this method is potentially promising. Stenoses located in ileoanal pouches are difficult to repair surgically, with a considerable risk of definitive ileostomy; thus, the risk-benefit of dilation in this situation is particularly propitious to the procedure (Fig. 2). Again, while there are only few case series, in the most numerous, which included 150 patients with stenoses at different sites in the pouch, endoscopic dilation allowed maintenance of the pouch at 5, 10 and 25 years in 97%, 90.6% and 86% of cases, respectively16.

 
FIGURA 2. Entrada y salida de las estenosis (A) y el tratamiento de la dilatación con balón (B y C).
 

Length of the stenosis. In addition to being more difficult to tackle from a technical perspective, longer strictures have worse outcomes in terms of avoidance of surgery over time. A meta-analysis by Hassan et al.17, which included 13 studies and a total of 347 patients with CD, found that the only factor related to the success of the procedure in the multivariate analysis was a stricture length of less than 4 cm (OR = 4.01; 95%: 1.16-13.8, p <0.028). In one of the few prospective studies published to date18, the length of the stenoses that eventually require surgery was significantly greater than that of those treated with dilation alone (7.5 cm vs 2.5 cm, p = 0.006). Therefore, in order to be eligible for endoscopic dilation, stenoses should measure no more than 4–5 cm in length, a limit established by most series published to date19,20, although this does not mean that longer stenoses (up to 7 cm) cannot be treated in this manner in certain cases, albeit with a lower success rate.

Number of strictures. In general, it is recommended that single strictures be dilated21; however, the number of cases with more than one stenosis described in the literature is very small (1.7% in Hassan’s meta analysis). It is therefore not possible to confirm whether this is a precondition for successful treatment. However, the presence of multiple stenoses in ileoanal pouches is associated with an increased risk of treatment failure, even when their number is small16.

Likelihood of malignancy and underlying disease. The presence of a stenosis should arouse suspicion of a neoplasm, consequently making biopsy mandatory. Such an eventuality in the small intestine is very rare, occurring primarily in patients with long-standing CD. However, the probability of malignancy in the colon is high and depends on the underlying disease. It is more frequent in the context of stenoses observed in ulcerative colitis (up to 25% of cases)22 vs. CD (6.8%)23. In addition to taking biopsies, it is therefore important to try to determine the whole length of the stricture24, with a paediatric endoscope if necessary (Video 1), in addition to other imaging techniques (CT/MRI) (Fig. 3).

In ulcerative colitis, the incidence of stenoses is rare, ranging from 3.4 to 11% of patients, although we have already seen that the probability of malignancy is high.

 
FIGURA 3. Estudio de TC de estenosis en ángulo esplénico
 

The risk factors for malignancy 22 are:

• Onset late in the course of disease (61% in patients with a course of disease longer than 20 years vs 0% when less than 10 years).

• Location proximal to the splenic flexure (86% vs 47% in the sigmoid colon and 10% in the rectum).

• Presence of obstructive symptoms.

Therefore, in patients with proximal stenoses, long-standing disease and obstructive symptoms, it seems reasonable to indicate surgery even when biopsies are negative. In any case, a stenosis in the context of ulcerative colitis that does not meet these criteria should be monitored closely even when biopsies detect no malignancy.

Presence of local complications: fistula or abscess. For most authors18,25,26, the presence of fistulas or abscesses in the stenotic area is a contraindication to endoscopic dilation probably because, intuitively, the risk of complications associated with the procedure is greater, and because, in this case, the advantages of surgery are obvious.

Presence or absence of inflammatory activity. There is controversy over whether or not to perform dilation when endoscopic activity is present, although the limited data available in the literature supports the procedure being safe and effective in this context. This does not mean that dilation is the first-line therapy in patients with activity, but rather that the procedure may be performed when faced with a stenosis that one has decided to dilate and in which activity is detected during endoscopy.

Here is a brief summary of the current evidence in this regard. The first study to be considered is a meta-analysis conducted by Hassanet et al.17 which found no differences between patients with active vs. inactive disease, although no activity criteria were specified. Nor were there any differences observed in terms of the need for dilation vs. surgery in function of the C-reactive protein or the existence of endoscopic activity in the article by van Asscheet et al.20, which is among the studies with the longest follow-up and largest sample size. However, in this publication, most stenoses were anastomotic and marked activity was present in only in a minority of patients27. According to the study conducted by Scimeca et al.28, severe activity also does not entail a greater need for surgery. The only publication whose results contradicted these was a retrospective study of 135 patients, in which a multivariate analysis found the presence of mucosal inflammation to be associated with a two-fold increase in the probability of surgery during follow-up (HR = 2.4; p = 0.03)29. No further complications have been observed in the presence of activity, although the sample size in the various series is too low to allow differences to be detected. However, it seems to be a safe procedure;  thus, in a series of 61 patients, 75% of whom had endoscopic activity, only one perforation occurred30.

In view of these factors, in order to be eligible for endoscopic dilatation, a stenosis should ideally be easy to access, non-angulated, with no associated fistula or abscess, short, single, with no evidence of malignancy and low activity. However, as always, this is a procedure that should be individualised in a manner such that it may be indicated in situations where not every criterion is fulfilled (for example, in patients with comorbidities and several prior resections).

 

ENDOSCOPIC DILATION TECHNIQUE: DILATION EQUIPMENT AND METHODS

The introduction of the balloons via the endoscope (through the scope [TTS]) has allowed the dilation of a stenosis outside of the oesophagus or rectum to be accessed. The technique is very simple and involves inserting a balloon through the stenosis before inflating it. From here on, there are significant variations in terms of the techniques described by the different authors with respect to the maximum balloon diameter used, dilation using different diameters, the maximum starting diameter, the number of dilations, the duration of inflation (1 to 5 minutes), whether or not a guide is used, whether radioscopy is used, etc.

The most commonly used maximum diameters are 18 mm and 20-25 mm. While there do not appear to be differences between these in terms of effectiveness17, there are some in terms of complications, particularly between all the 25 mm ones vs. those of smaller diameter (9.3% vs 3.5%; p >0.01)26.

The number of dilations per session varies widely, but in the vast majority of studies, attempts are made to thread the endoscope through the stenosis before proceeding to dilation, meaning a minimum calibre of 12–13 mm, which is termed a “technical success”. This definition is arbitrary; indeed, symptomatic relief is achieved in some patients, even when the above is not. Thus, according to the previously mentioned meta-analysis by Hassan, whether or not “technical success” is achieved does not does reflect on the results. What it does provide is an idea of the minimum diameter achieved as an immediate efficacy parameter (Video 2).

 

 

In the case of long stenoses, this is done using a guide and dilated in segments18. Some authors resort to corticosteroid injection13, while others make use of electrosurgery incisions in refractory stenoses31.

In our centre, we use progressive dilation (1 minute) starting with 12-15 mm balloons for stenoses measuring less than 5 mm, or directly with 15-18 mm balloons in the case of longer ones. The target balloon diameter (18 mm) is achieved in a single session, which is repeated if the endoscope fails to pass through the stricture.

 

SUBSTANCE INJECTION

 

Corticosteroids

Several series have described attempts to improve the effectiveness of endoscopic dilation by injecting corticosteroids, usually triamcinolone (40 mg in 4.5 ml, 4 quadrants) after dilation13,14,32,33. However, an analysis of all these studies combined17 does not show greater effectiveness compared to patients treated with dilation alone. Two placebo-controlled clinical trials were subsequently published, with conflicting results (Fig. 4). The first34 included only 13 patients and was stopped prematurely due to low recruitment. Under these circumstances, no differences were found between groups and even the results with corticosteroids were worse than placebo in the per protocol analysis: 5/7 patients who received steroids required another dilation vs 1/5 of those in the placebo group (p = 0.07). This study was instrumental in stopping this procedure from being adopted for the treatment of stenoses in IBD, unlike in other indications35. The second study36, which had a similar design and was conducted in the paediatric population, included a total of 29 patients. Dilation was less frequently required in the group treated with corticosteroids (1/15 vs 5/14) or surgery (0/15 vs 4/14), although the difference was not statistically significant. However, the duration of the clinical effectiveness of dilation, with no need for further dilation or surgery, was significantly higher in the group treated with triamcinolone. Taking into account all the above and in the absence of better data, corticosteroid injections appear to increase the efficacy of dilation, although it remains unknown whether this should be used routinely or only when the first dilation has failed.

 
FIGURA 4. Resultados de los dos ensayos clínicos que valoran la eficacia de la inyección de corticoides tras la dilatación.
 

Anti-tumour necrosis factor (anti-TNF)

Infliximab injections have been used in rheumatology37, perianal fistulas associated with CD38-41, and even in the treatment of endoscopic recurrence42; it therefore seems reasonable to attempt local administration in stenoses exhibiting inflammatory activity. There are just four case series43-46 that, when pooled together and assessing only the indication of stenosis, include a total of 14 patients, with efficacy in 11 of them (increased luminal diameter and improvement of ulceration). While the posology varied, the most common regimen consisted of injecting 100 mg of infliximab along the stenosis at variable intervals45,47. A controlled, open-label study of 23 patients47 was recently presented that compared infliximab injections followed by dilation vs. dilation alone. The results were in favour of the combination therapy group, although not statistically significantly so (new dilation 33% vs 54%). Therefore, while the initial data is promising, both the effectiveness of the approach in controlled studies, and its place in clinical practice, remain to be established.

 

RESULTS AND SHORT- AND LONG-TERM FOLLOW UP

Before describing the results of this approach, it is necessary to emphasise the poor quality of the available evidence.

No randomised or controlled studies have been conducted (except for the the above-mentioned two involving steroid injections), and virtually all were open-label and retrospective, with significant heterogeneity in terms of the techniques employed, making it difficult to draw conclusions. Many of the studies included a high proportion of anastomotic stenosis, whose pathogenesis is different than that of IBD or de novo stenoses. Finally, the influence of medical treatment is unknown, since it remained unchanged in most publications.

With these limitations in mind, a summary of the results is shown in Table I. Technical success, that is to say, the successful passage of the endoscope through the stenosis is achieved in 90% of cases (weighted average), avoiding the need for surgery in 30% of patients, with a mean follow-up of five years. The aforementioned has a reduced rate of complications, with a 3.2% perforation rate. Single dilatation allows surgery or new dilations to be avoided in 70% of patients in the first year, in about 50% at three years, and 42% at five years26.

Currently available data makes it difficult to find differences between de novo and anastomotic stenoses26,29; however, in some series18 the efficacy of the procedure is lower in de novo stenoses, although not statistically significantly so. A series was recently published that showed significantly better results in anastomotic stenosis48, although the differences were small.

How could these results be improved?

First, stepping up medical treatment could play a significant role. Stenoses with a greater fibrous component from a radiological point of view (CT/MR) are susceptible to dilation; however, the distinction between fibrosis and inflammation is suboptimal (Fig. 5). A retrospective study of 22 patients that correlated post-surgical histology with CT findings found that the inflammatory component of stenoses that are considered fibrous is important. Something similar occurred with findings considered characteristic of non-inflammatory stenosis, such as proximal dilation49. Therefore, it makes sense to step up treatment, although this has been little studied in the literature. There is only one small randomised controlled study of 30 patients that compared azathioprine with budesonide versus placebo after dilation, which found better results at one year in the experimental group (3% vs 20%; p <0.05). The reverse also seems reasonable, namely, complementing medical treatment with the dilation of residual stenosis in stenoses presumed inflammatory. Again, only one study of just 33 patients supports this strategy, which found differences in favour of the combination of infliximab and dilation vs. the drug alone50. An algorithm for the management of CD stenosis is shown in Figure 6.

 
Tabla_SEC3_02_01_T01
 
FIGURA 5. Componentes de inflamación y fibrosis en las estenosis según su consideración radiológica y en aquellas con dilatación proximal.
 
FIGURA 6. Algoritmo de tratamiento de las estenosis en la EII.
 
Another possible strategy proposed to improve effectiveness in the medium to long term involves performing repeat dilations at fixed intervals, even when the patient is asymptomatic. Only one study of 53 patients compared the standard strategy of single dilation with regular sessions, showing better results with the latter25. However, it remains to be determined which patients would benefit from this approach, since a large proportion remains asymptomatic after a single dilation.

 

OPTIONS IN THE EVENT OF RECURRENCE: HOW MANY TIMES CAN THE PROCEDURE BE REPEATED?

While the effectiveness of a single dilation has been demonstrated, the procedure may be repeated if symptoms reoccur. In the largest series, the procedure was repeated in 45–66% of patients20,26, thus avoiding surgery in 64–76% of cases at five years of follow-up, with only one or two further dilations in most cases. However, each new dilation affords the patient a shorter symptom-free interval; thus, after the first procedure, the median time to recurrence is 12.5 months, falling to eight months after the second20; this is why it does not seem adequate for the number of dilations to be indefinite; instead, it should depend on the symptom-free interval afforded by each procedure. If recurrence occurs early, disease activity should be reassessed and one should consider either stepping up medical treatment or modifying the approach, using steroid injection if this has not been done before, as this seems effective despite the limited available data. A new recurrence calls for surgery, although other alternatives, such as the placement of a self-expanding stent, could be an option.

Unlike in other locations, no particular number of dilations has been defined at which stenoses are deemed refractory; however, it seems reasonable to seek a balance between the number of procedures performed and the results that may be achieved, given that the treatment goal is not so much to avoid surgery as to achieve lasting symptomatic control.

Lastly, individualised treatment decisions should be insisted upon in this situation too.  In patients who have never had surgery, and in whom the stenotic area is short, surgical resection is likely to be the treatment option that will afford them the longest disease- and symptom-free interval, always in combination with the appropriate recurrence prevention treatment. However, in patients with a prior history of surgery or comorbidities, endoscopic dilation should be regarded as an effective and reasonably safe option. In this regard, the few studies that have attempted to compare this procedure with strictureplasty have failed to find a significant difference between the two in terms of the likelihood of recurrence51,52.

 

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52. Wibmer AG, Kroesen AJ, Grone J, Buhr HJ, Ritz JP. Comparison of strictureplasty and endoscopic balloon dilatation for stricturing Crohn’s disease–review of the literature. Int J Colorectal Dis. 2010; 25(10): 1149-57. Epub 2010/07/16.

 

PÁGINA ANTERIOR: << III.2 Manejo endoscópico de las estenosis en la Enfermedad Inflamatoria Intestinal
PÁGINA SIGUIENTE: >> III.2.2 Enteroscopia. Dilatación con balón y otras utilidades terapéuticas
ÍNDICE COMPLETO: << Volver al Índice ENDI

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