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

NCT ID: NCT06603298

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 182 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-17
• Study Completion Date: 2025-10-17

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.

Conditions

Crohn Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Medical therapy alone

It includes patients with Crohn's disease who were only treated with biological therapy for clinically significant intestinal stenosis. These patients underwent drug treatment without any endoscopic procedure.

No interventions assigned to this group

Medical therapy + endoscopic dilatation

It includes patients who received both endoscopic dilatation (ED) with a balloon and biological therapy. This cohort underwent combined treatment for intestinal stenosis, integrating mechanical and pharmacological intervention.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Franco Scaldaferri, PI

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Gemelli, Rome

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD

Roma, , Italy

Countries

Italy

Other Identifiers

ENDO_BIO- CROHN- ID 6815

Identifier Type: -

Identifier Source: org_study_id