Intralesional steroid injection after endoscopic balloon dilation in pediatric Crohn's disease with stricture: a prospective, randomized, double-blind, controlled trial

doi:10.1016/j.gie.2010.08.003

Gastrointestinal Endoscopy

Volume 72, Issue 6, December 2010, Pages 1201-1208

https://doi.org/10.1016/j.gie.2010.08.003 Get rights and content

Background

Endoscopic balloon dilation (EBD) is an attractive conservative therapy for Crohn's disease (CD) with stricture; however, its long-term efficacy has been questioned because many patients require more dilations or postdilation surgery. Most reports are retrospective, and no pediatric data are available.

Objective

To assess the effectiveness of corticosteroid intralesional injection after EBD in preventing stricture recurrence.

Design

Single-center prospective, randomized, double-blind, controlled trial.

Setting

Tertiary-referral university hospital.

Patients

Between November 2005 and January 2009, 29 pediatric patients with stricturing CD were enrolled.

Interventions

Enrolled patients were randomized to receive intrastricture injection of corticosteroid (CS) (n = 15) or placebo (n = 14) after EBD. Patients were followed clinically via small intestine contrast US and intestinal magnetic resonance imaging at 1, 3, 6, and 12 months; all underwent colonoscopy 12 months after dilation.

Main Outcome Measurements

Time free of repeat dilation and time free of surgery in the 2 groups.

Results

One of the 15 patients receiving CS required redilation, whereas the latter was needed in 5 of the 14 placebo patients; surgery was needed in 4 of the placebo patients, but in none of those receiving CS. The 2 groups statistically differed in the time free of redilation (P = .04) as well as for time free of surgery after EBD (P = .02), which were worse in the placebo group compared with the CS group. There were no significant differences in baseline demographics between the 2 groups.

Limitations

Sample size, participation bias, and short-term follow-up.

Conclusion

In pediatric CD with stricture, intralesional CS injection after EBD is an effective strategy for reducing the need both for redilation and surgery.

Section snippets

Patients and methods

Between November 2005 and January 2009, 29 pediatric patients (13 female patients; median age 14.5 years; range 9-17.5 years) with stricturing CD were enrolled. Inclusion criteria were obstructive symptoms (abdominal cramps, nausea, vomiting, feeding difficulties or inability) with evidence of gut narrowing and prestenotic dilation on small intestine contrast US (SICUS) and intestinal magnetic resonance imaging (MRI); nonobstructive symptomatic patients (failure to thrive, weight loss,

Results

Fifteen patients were randomized to CS (7 female patients; median age 13.6 years, range 9-17 years) and 14 to placebo (6 female patients; median age 14.5 years, range 10.5-17.5 years). All had follow-up evaluations until 12 months after the last dilation. The 2 groups did not differ in clinical details, stricture characteristics, and concomitant medications (Table 1). The sites of strictures were the ileocolonic anastomosis in 8 patients (4 in the placebo group and 4 in CS group), the

Discussion

Strictures occurring both in the small bowel and the colon are a common complication of CD.¹ Epidemiological data from pediatric registries in Europe and the United States indicate that at diagnosis, most patients with CD exhibit a nonstricturing and nonpenetrating phenotype, whereas at a 5-year follow-up, a dramatic change in disease behavior occurs, with roughly 30% of patients evolving toward a stricturing disease.³ However, previous data revealed that at diagnosis, a stricturing disease is

Acknowledgment

Thanks to Patrizia Schifano for the statistical analysis.

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A pesar de los avances farmacológicos, la estenosis en la Enfermedad de Crohn (EC) sigue siendo un problema importante que obliga en un alto porcentaje de pacientes a realizar tratamientos endoscópicos y/o quirúrgicos. No existen en la actualidad índices clínicos o herramientas diagnósticas que nos permitan predecir qué pacientes desarrollarán esta complicación, y actualmente cuando una estenosis se diagnostica, suele estar ya bien establecida y clínicamente relevante. El papel actual del tratamiento farmacológico se limita a tratar la inflamación y una vez que existe una fibrosis importante, las únicas opciones terapéuticas son las endoscópicas y/o quirúrgicas. Para poder establecer un correcto algoritmo terapéutico y con base en la evidencia científica disponible en este momento, el grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) ha decidido realizar este documento de posicionamiento sobre el tratamiento de la estenosis en la EC. Este documento abarca los tres abordajes terapéuticos mencionados, médico, endoscópico y quirúrgico. Se establecen recomendaciones y algoritmos terapéuticos que nos permitan ayudar a elegir la opción más adecuada en función de las características de la estenosis y del paciente.
Despite pharmacological advances, strictures in Crohn's disease (CD) continues to be an important problem that leads in a high percentage of patients to undergo endoscopic and/or surgical treatments. There are currently no clinical scores or diagnostic tools that allow predicting which patients will develop this complication, and when a stricture is diagnosed, it is usually already well established and clinically relevant. The current role of pharmacological treatment is limited to treat inflammation and once there is significant fibrosis, the only therapeutic options are endoscopic and/or surgical. To establish a correct therapeutic algorithm and based on the current scientific evidence available, the Spanish Group Working on Crohn's Disease and Ulcerative Colitis (GETECCU) has decided to conduct this position statement on the treatment of strictures in CD. This document embraces the three mentioned therapeutic approaches, medical, endoscopic and surgical. Recommendations and therapeutic algorithms are established to help us to choose the most appropriate option based on the characteristics of the stricture and the patient.
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Stricture formation is a common complication of Crohn's disease, resulting from the disease process, surgery, or drugs. Endoscopic balloon dilation has an important role in the management of strictures, with emerging techniques, such as endoscopic electroincision and stenting, showing promising results. The underlying disease process, altered bowel anatomy from disease or surgery, and concurrent use of immunosuppressive drugs can make endoscopic procedures more challenging. There is an urgent need for the standardisation of endoscopic procedures and peri-procedural management strategies. On the basis of an extensive literature review and the clinical experience of the consensus group, which consisted of representatives from the Interventional Inflammatory Bowel Disease Group, we propose detailed guidance on all aspects of the principles and techniques for endoscopic procedures in the treatment of inflammatory bowel disease-associated strictures.
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Other endoscopic techniques that have been proposed include triamcinolone corticosteroid injection into CD-related strictures. Although this approach has been successful in reflux-related esophageal strictures, one prospective study in pediatric CD demonstrated benefit, but one study in adult CD was prematurely terminated due to worse outcome in patients with corticosteroid injection in CD-strictures [88,89]. Case reports of injecting TNF antagonists into CD-associated strictures have been reported as successful [90,91] although this approach has not been widely accepted, particularly in light of cost considerations and findings from the CREOLE study suggesting possible benefit to systemic TNF antagonist administration.
Intestinal fibrosis with stricture formation affects up to half of patients with Crohn’s disease (CD), resulting in impaired quality of life, increased risk of surgical intervention, and associated patient morbidity. The underlying pathophysiologic mechansisms responsible for initiating and perpetuating intestinal fibrosis are complex, dynamic, and implicate both inflammation-dependent and independent pathways. Previously thought to be an irreversible complication of long-standing inflammation unresponsive to medical therapy, fibrostenotic CD has been traditionally managed with endoscopic or surgical approaches. However, recent advances in our understanding of the humoral, cellular, and environmental pathways driving intestinal fibrosis has the potential to fundamentally change these management paradigms for CD-related strictures. Furthermore, the promise of fibrosis treatments in other organ systems has encouraged hope that anti-fibrotic treatment approaches for CD may be within reach. Here, we summarize the key breakthroughs in our molecular understanding of intestinal fibrosis, review current medical, endoscopic, and surgical treatment approaches to CD-related strictures, propose future directions for anti-fibrotic therapy in CD, and identify crucial research questions in this field that require additional investigation.
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Endoscopic Balloon Dilatation in Pediatric Crohn Disease: An IBD Porto Group Study
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: DISCLOSURE: All authors disclosed no financial relationships relevant to this publication.

^⁎: Drs Di Nardo and Oliva contributed equally to this article.

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Original Article: Clinical EndoscopyIntralesional steroid injection after endoscopic balloon dilation in pediatric Crohn's disease with stricture: a prospective, randomized, double-blind, controlled trial

Background

Objective

Design

Setting

Patients

Interventions

Main Outcome Measurements

Results

Limitations

Conclusion

Section snippets

Patients and methods

Results

Discussion

Acknowledgment

Lancet

J Pediatr

Gastroenterology

Gastroenterology

Gastroenterology

Gastroenterology

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

Clin Gastroenterol Hepatol

Ultrasound Med Biol

Medical therapy for Crohn's disease strictures

Inflamm Bowel Dis

Primary and recurrent Crohn's diseaseExperience with 1379 patients

Ann Surg

The long-term results of resection and multiple resections in Crohn's disease

Semin Gastrointest Dis

Natural history of recurrent Crohn's disease at the ileocolonic anastomosis after curative surgery

Gut

Recurrence and reoperation after strictureplasty for obstructive Crohn's disease: long term results

Br J Surg

Endoscopic therapy of strictures in Crohn's disease

Inflamm Bowel Dis

Original Article: Clinical Endoscopy
Intralesional steroid injection after endoscopic balloon dilation in pediatric Crohn's disease with stricture: a prospective, randomized, double-blind, controlled trial