For treatment of Crohn disease strictures, endoscopic balloon dilation (EBD) is more effective than fully covered self-expandable metal stents (FCSEMS) and should be the preferred endoscopic treatment, according to a multi-center, open-label study published in The Lancet Gastroenterology & Hepatology (ClinicalTrials.gov Identifier: NCT02395354).

While the established endoscopic treatment for short strictures in Crohn disease is EBD, FCSEMS have been used in patients who underwent unsuccessful EBD. As there are no randomized controlled trials comparing endoscopic treatments for fibrostenosing

Crohn disease, researchers sought to compare the efficacy, safety, and financial costs of EBD vs FCSEMS for the treatment of Crohn disease strictures.


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From August 28, 2013 to October 9, 2017, 80 patients were included in the study and randomly assigned to treatment: 41 (51%) patients to the EBD group and 39 (49%) patients to the FCSEMS group. Demographics characteristics in the EBD vs FCSEMS group were as follows: mean patient age was 47 vs 43 years, 39% vs 59% were women, 80% vs 72% reported being current smokers, and time from Crohn disease diagnosis at study enrollment was 17 vs 16 years, respectively.

The researchers found that 33 (80%) patients in the EBD group and 20 (51%) patients in the FCSEMS group were free of a new therapeutic intervention due to symptom recurrence at 1 year (P =.0061). Patients in the EBD group had increased symptom-free survival compared with the FCSEMS group at 1 year (80% vs 51%; P =.0043). Treatment efficacy was also longer in the EBD group compared with the FCSEMS group (148.6 vs 89.7 days).

A cost analysis indicated that EBD was less expensive than FCSEMS placement for the treatment of Crohn disease strictures (mean cost, €1365.63 vs €1923.55). The researchers noted that the shorter a patient’s stricture, the greater the likelihood of successful treatment with EBD; thus, it is imperative not to delay EBD when patients begin to show obstructive symptoms.

Only 2 (3%) patients overall had severe adverse events (1 [2%] patient in the EBD group and 1 [3%] patient in the FCSEMS group), both of which were perforations. No procedure-related patient deaths were reported.

Investigators note this research was not free from limitations, as both study participants and medical staff were not blinded to treatment allocation. Additionally, the majority of patients had short strictures, which could potentially limit the ability to achieve more favorable results via FCSEMS.

“In summary, our findings show that both endoscopic treatments have good safety profiles, but that EBD is more effective than FCSEMS for Crohn’s disease strictures,” researchers concluded. “Therefore, EBD should be the preferred endoscopic treatment for Crohn’s disease strictures.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. 

Reference

Loras C, Andújar X, Gornals JB, et al, on behalf of the Grupo Español de Trabajo de la Enfermedad de Crohn y Colitis Ulcerosa (GETECCU). Self-expandable metal stents versus endoscopic balloon dilation for the treatment of strictures in Crohn’s disease (ProtDilat study): an open-label, multicentre, randomised trial. Lancet Gastroenterol Hepatol. Published online January 20, 2022.  doi: 10.1016/S2468-1253(21)00386-1