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

NCT06603298 | Active Not Recruiting

• 1 other identifier: ENDO_BIO- CROHN- ID 6815
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with transitable colonoscopy at 12 months assessed by endoscopic and radiological documentation

  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.

  12 months

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with Crohn\'s disease

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Franco Scaldaferri, PI

  Fondazione Policlinico Gemelli, Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: October 17, 2024
• Primary Completion: October 17, 2025
• Study Completion: October 17, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-09

Locations

IT (1)