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

Active, not recruiting

• Conditions: Crohn Disease

• Registration Number: NCT06603298
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-16
• Study First Submitted QC: 2024-09-18
• Study First Posted: 2024-09-19
• Study Start: 2024-10-17
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-24
• Primary Completion: 2025-10-17
• Study Completion: 2025-10-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

• Age ≥ 18 years,
• Confirmed diagnosis of Crohn's disease;
• Radiological or endoscopic evidence of Crohn's disease complicated by clinically significant intestinal stenosis treated by endoscopic balloon dilatation.
• Minimum 12-month clinical follow-up at this hospital;
• Ability to express and give informed consent for participation in the study and to adhere to the timetable of scheduled visits.

Exclusion Criteria

• Age <18 years;
• Patients with pouch or terminal ileostomy;
• Any clinical condition that, in the opinion of the investigators, may contraindicate enrolment in the study;
• Unstable personality or inability to adhere to protocol procedures;
• Inability to express and give informed consent for study participation and to adhere to the participation in the study and to adhere to the timing of the planned visits.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with transitable colonoscopy at 12 months assessed by endoscopic and radiological documentation	12 months	Measurement of the percentage of patients with Crohn's disease and intestinal stenosis who obtain a transitable colonoscopy after 12 months of follow-up, comparing two interventions: single biological therapy vs. endoscopic dilatation combined with biological therapy. Transitability of the colonoscopy will be determined by the ability of the colonoscope to completely pass through the stenosis as documented in the endoscopic and/or radiological reports. Data will be aggregated as the proportion of patients with transitable colonoscopy in the total number of patients in each treatment group.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD; 🇮🇹 Roma, Italy