Clinical trial NCT06603298: Evaluation of the Efficacy and Safety of Endoscopic Dilatation and Biological Therapy in Intestinal Stenosis Due to CD
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Crohn Disease
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with Crohn\&#39;s disease

Brief summary: All patients with Crohn\&#39;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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years,
* Confirmed diagnosis of Crohn\&#39;s disease;
* Radiological or endoscopic evidence of Crohn\&#39;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 \&lt;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.

Primary outcomes:
measure: Proportion of patients with transitable colonoscopy at 12 months assessed by endoscopic and radiological documentation
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD
Study officials:
affiliation: Fondazione Policlinico Gemelli, Rome
name: Franco Scaldaferri, PI
role: PRINCIPAL_INVESTIGATOR
References: