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NCT Number: NCT06603298

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD

Roma, 00168, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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