NCT06603298

Evaluation of the Efficacy and Safety of Endoscopic Dilatation and Biological Therapy in Intestinal Stenosis Due to CD

Evaluation of the Efficacy and Safety of Endoscopic Dilatation Combined With Biological Therapy Therapy for the Treatment of Intestinal Stenosis in Patients With Crohn's Disease

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 182 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

All patients with Crohn\'s disease, already undergoing biological therapy for the treatment of clinically significant intestinal stenosis and/or already undergoing endoscopic balloon dilatation during the period January 2016 - June 2024 will be enrolled.

Detailed description

All patients meeting all inclusion criteria and no exclusion criteria will be offered participation in the study upon presentation of the information form and signing of the informed consent for participation in the study. Each patient will be assigned a progressive identification number (ID). All clinical data will be recorded for all patients: * Demographic data (age, sex, smoking habits) * Montreal classification; * Duration of disease; * History of previous surgery; * Past and current drug therapy. All available data on stenosis characteristics will be recorded: * Localisation (ileal, ileo-caecal, colic, anastomotic); * Extent (mm); * Evidence of concurrent endoscopic disease activity locally All data related to the endoscopic procedure will also be recorded: * Size of device used; * Maximum dilatation achieved (mm); * Technical success, assessed by endoscopic clearance of the stenosis after the dilation procedure; * Consensual local steroid injection; * Possible multiple endoscopic dilation sessions; The occurrence of episodes of intestinal sub-occlusion or occlusion will be recorded, the introduction of steroid therapy and the need for surgery. Where available radiological and endoscopic re-evaluation data will be recorded. Any changes in treatment and any adverse events, defined as any adverse event, will also be recorded. as any adverse event without a necessary causal relationship with the endoscopic procedure and the concomitant ongoing biological therapy.

Conditions

• Crohn Disease

Timeline

• Start date: 2024-10-17
• Primary completion: 2025-10-17
• Completion: 2025-10-17
• First posted: 2024-09-19
• Last updated: 2024-12-24

Locations

1 site across 1 country: Italy