Balloon dilation versus endoscopic stricturotomy in the treatment of Crohn's anastomotic stricture: experimental randomized study.

BACKGROUND

Up to 80% of patients with Crohn's disease (CD) require surgery, and anastomotic strictures are a frequent postoperative complication with limited response to medical therapy. Endoscopic balloon dilation (EBD) and endoscopic stricturotomy (ESt) are widely used minimally invasive treatments, though comparative evidence remains scarce. Standardized animal models enable controlled assessment of therapeutic efficacy. This study compared EBD and ESt in a randomized experimental model replicating CD-associated anastomotic strictures.

METHODS

A chemically induced anastomotic stricture model was established in miniature pigs using a standardized ileo-sigmoid side-to-side anastomosis followed by serial TNBS/phenol injections. Forty-four animals with confirmed strictures were randomized to EBD, ESt, or control groups. Interventions consisted of graded balloon dilation or needle-knife stricturotomy with clip closure. Stricture diameter was measured endoscopically at baseline and every 8 weeks for 6 months. Primary outcomes were change in anastomotic diameter and long-term luminal patency. Secondary outcomes included adverse events and animal welfare indicators.

RESULTS

Both EBD and ESt increased anastomotic diameter compared with baseline. Significant improvement occurred only after ESt (final diameter 17.51 ± 4.71 mm vs. 11.27 ± 1.46 mm at baseline; p = 0.0002). EBD produced a non-significant trend toward enlargement (16.09 ± 5.35 mm; p = 0.0554). Diameter gain over 6 months was significantly greater with ESt than EBD (6.24 ± 4.40 mm vs. 3.31 ± 5.01 mm; p = 0.042). Controls showed no meaningful change. Three perforations occurred (two EBD, one ESt), all treated endoscopically without mortality. Weight gain and overall health status were comparable across groups throughout follow-up.

CONCLUSION

In this randomized experimental study, both EBD and ESt were technically feasible and safe. ESt resulted in significantly greater and more durable luminal enlargement than EBD. These findings support stricturotomy as a potentially more effective endoscopic option for fibrostenotic CD and may help reduce or delay surgical intervention in affected patients.