Though both endoscopic balloon dilation (EBD) and fully covered self-expandable metal stents (FCSEMS) have good safety profiles, EBD is more effective for Crohn disease (CD) strictures, according to a study published in The Lancet.
Researchers conducted an open-label, multicenter, randomized clinical trial, called ProtDilat (ClinicalTrials.gov Identifier: NCT02395354), in 19 secondary and tertiary Spanish hospitals. The study included 80 adults with CD with obstructive symptoms and fibrotic strictures measuring less than 10 cm long. Study participants were randomly assigned 1:1 to either EBD or FCSEMS. Those in the EBD group underwent dilation using a CRE Boston Scientific pneumatic balloon for a maximum of 2 sessions with at least 15 to 30 days between sessions. Those in the FCSEMS group received a Taewoong fully covered metal stent 20 mm in diameter.
The primary outcome was efficacy of endoscopic treatment, measured by the proportion of study participants who did not require new therapeutic intervention (EBD, FCSEMS, or surgery) to manage recurrence of symptoms at 1 year of follow-up. All adverse events were recorded and were categorized as possibly, probably, or definitely associated with the procedure. Secondary outcomes included safety, symptom-free survival, and mean costs.
At the 1-year mark, 80% of those in the EBD group were free of a new therapeutic intervention compared with 51% of those in the FCSEMS group (odds ratio, 3.9; 95% CI, 1.4-10.6; P =.0061). Severe adverse events occurred among 3% (n=2) of participants and included 1 perforation in each group.
Study limitations included a lack of masking to treatment, studying patients with short strictures, and a lack of analysis of cost-effectiveness.
The researchers concluded that “both endoscopic treatments have good safety profiles, but that EBD is more effective than FCSEMS for [CD] strictures. Therefore, EBD should be the preferred endoscopic treatment for [CD] 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.
Loras C, Andújar X, Gornals JB, et al. 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. 2022;7(4):332-341. doi:10.1016/S2468-1253(21)00386-1