Crohn DiseaseNCT06603298
Evaluation of the Efficacy and Safety of Endoscopic Dilatation and Biological Therapy in Intestinal Stenosis Due to CD
An observational study of Crohn Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- How many people
- 182 participants
- Where
- 1 siteItaly
- Study dates
- 17 Oct 2024to 17 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: patients with Crohn\'s disease
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD
Roma, 00168
About this study
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
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.
Read the 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
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start17 Oct 2024
- Primary completion17 Oct 2025 (estimated)
- Study completion17 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franco Scaldaferri, PI, Principal investigator, Fondazione Policlinico Gemelli, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603298
- Sponsor's protocol ID
- ENDO_BIO- CROHN- ID 6815
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06603298
- Acronym / sponsor ID
- ENDO_BIO- CROHN- ID 6815
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 17 Oct 2025 (estimated)
- Study completion
- 17 Oct 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with Crohn\'s disease
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
Related trials for Crohn Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franco Scaldaferri, PI principal investigator
Fondazione Policlinico Gemelli, Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with transitable colonoscopy at 12 months assessed by endoscopic and radiological documentation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.