Crohn DiseaseNCT04803916
Pre-stenotic Inflammation Following Endoscopic Balloon Dilatation in Crohn's Disease: A Prospective Study
An observational study of Crohn Disease, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
As a consequence of chronic relapsing inflammation in Crohn's disease (CD), progressive bowel damage and scarring occurs in affected regions of intestine. This damage often leads to narrowing, or stricturing of the bowel lumen, and even complete bowel obstruction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Crohn Disease
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2020to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This prospective, observational study will include both pediatric and adult patients with stricturing CD on stable therapy who are planned to undergo EBD for management of a Crohn's stricture.
Who may be able to join
- Patients diagnosed with CD as per most recent international guidelines.
- Presence of strictured bowel (jejunal, ileal, colonic or ileocecal valve), either primary or anastomotic in nature, with prestenotic dilatation >2.5cm loop diameter as demonstrated on cross-sectional imaging (Magentic Resonance Enteroclysis (MRE), Computerized Tomography Enteroclysis (CTE) or ultrasound (US))
- Evidence of pre-stenotic inflammation defined as wall thickness ≥5mm on cross-sectional imaging, or pre-stenotic SES-CD ≥3.
- Planned EBD as per clinical management.
- Unchanged CD medications - 3 months no change in therapy including immunomodulators (thiopurines or methotrexate), biological therapies, corticosteroid therapy, or nutritional therapy with exclusive enteral nutrition (EEN) or partial enteral nutrition (PEN).
- No planned treatment changes or additions over the 3 months following recruitment. The treating physician can change treatment at any time should the clinical need arise however the patient will be excluded from primary analysis
Who cannot join
- Any patient deemed not appropriate for EBD by treating physician due to stricture- specific, or patient-specific reasons will not be included
- Change in therapy (dose or type) in the 3 months prior to planned EBD
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
As a consequence of chronic relapsing inflammation in Crohn's disease (CD), progressive bowel damage and scarring occurs in affected regions of intestine. This damage often leads to narrowing, or stricturing of the bowel lumen, and even complete bowel obstruction. Stricturing CD is thought to be a major contributor to penetrating complications including abscesses and fistulae.
Depending on the severity and clinical significance of fixed strictures, treatment options include either endoscopic balloon dilatation (EBD), or surgery with either resection or stricturoplasty recommended on a case-by-case basis.
Read more
EBD has been shown to be a safe alternative to surgery in management of CD strictures.
While the short- and medium-term clinical outcomes of EBD have been well described, less well studied is the impact of relieving Crohn's strictures on the inflammatory load proximal to the stricture. The restricted flow of fecal contents through a stricture creates a region of relative stasis in the bowel loops immediately proximal to the stricture, appreciated at times by pre-stenotic dilatation on cross-sectional imaging. This stasis fosters localized bacterial overgrowth and worsening dysbiosis in these bowel loops.
The investigators hypothesize that improvement of fecal flow by way of successful balloon dilatation of a CD stricture, could independently reduce the inflammatory burden, not only in the stenotic segment but also in the proximal loop of bowel.
Read the detailed description
This prospective, observational study will include both pediatric and adult patients with stricturing CD on stable therapy who are planned to undergo EBD for management of a Crohn's stricture.
Included patients are those in whom the treating physician is planning a colonoscopic EBD for a CD stricture. Patients will be followed with imaging, clinical assessment, serologic testing, stool microbiome and endoscopic assessment at time of EBD, and post-EBD. EBD will be performed to a target dilatation size of 18-20mm. If the stricture is deemed too narrow to allow dilatation to target size in a single session, graduated dilatations at a number of sessions can be undertaken at the treating clinician discretion. Time-point of week 0 will be defined as achievement of dilatation target size.
Clinical assessment, blood and stool for calprotectin and microbiome, and focused bowel US to be performed within a 4 week period prior to EBD. Previous imaging (US/MRE/CTE) from 2-4 months prior to EBD, where performed, will also be assessed.
In the absence of any contra-indication, repeat colonoscopy will be performed at week 12 (±2 weeks) to assess stricture size and assess extent of mucosal inflammation at the stricture site and the pre-stenotic region. Follow-up clinical review with repeat blood tests, stool for calprotectin and microbiome and focused bowel US will also be performed at week 12 (±2 weeks).
Endoscopic images from pre-stenotic bowel loop and bowel US from week 0 and week 12 will be centrally read by two central readers blinded to the patient and stage. An average of pre-stenotic region SES-CD score and US-derived outcome measures from both readers will be recorded. Where available, imaging from 2-4 months pre-EBD, either US, MRE or CTE, will be assessed by the same central readers.
Patients in whom successful balloon dilatation was achieved (see definitions below) will be included in the primary analysis. Patients in whom dilatation was attempted but was not successful (see below) will also be followed and will be analyzed as control group.
Patient's medications are to remain unchanged throughout the follow-up period, including biologic type or dose, or addition of corticosteroids/nutritional therapy, unless the treating physician decides otherwise on clinical grounds, in which case the patient will be defaulted from analysis. Patients on corticosteroid or nutritional therapy at recruitment can continue to wean therapy as per clinician directive.
- Conditions
- Crohn Disease
- Keywords
- Crohn, Stricture, Endoscopic Balloon Dilatation
- Medical subject headings
- Crohn Disease, Constriction, Pathologic
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic response
Decrease in SES-CD in the pre-stenotic region of ≥ 3 at 12 weeks compared to week 0
Measured: 12 weeks compared to week 0
Secondary outcomes (12)
Endoscopic healing
Post-endoscopic balloon dilatation (EBD) mucosal healing in pre-stenotic region defined as regional SES-CD ≤ 1
Measured: week 12
Wall thickness
≥30% reduced intestinal wall thickness in pre-stenotic loop of bowel 12 weeks following successful EBD
Measured: week 12 compared to week 0
Limberg score US
Decrease in Limberg grade of hyperemia in pre-stenotic region of ≥ 2
Measured: week 12 compared to week 0
Luminal diameter
>50% reduction of ratio of maximal upstream luminal diameter to minimal downstream luminal diameter
Measured: week 12 compared to week 0
Inflammed length
>50% reduced length of involved pre-stenotic inflamed region
Measured: week 12 compared to week 0
Obstructive score reduction
CDOS ≤ 1 at week 12
Measured: week 12
Clinical remission
Clinical remission as measured by physician global assessment (PGA). 0-100 mm scale 0 being full remission (lower score better outcome)
Measured: week 12
Stool calprotectin
>50% reduction in stool calprotectin at week 12
Measured: week 12 compared to week 0
No treatment escalation
No treatment escalation following EBD
Measured: week 12
Comparison of imaging and calprotectin
Comparison of outcome measures from cross-sectional imaging and stool calprotectin at week 12 between patients with successful EBD vs those with unsuccessful EBD "control".
Measured: week 12
Clinical remission
Clinical remission as measured by Crohn's Disease Activity Index (CDAI )< 150 at week 12.Lower score better outcome
Measured: week 12
Clinical remission
Clinical remission as measured by wPCDAI < 12.5 at week 12
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Nov 2020
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (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.
- 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
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Children's NHS Foundation Trust, Bambino Gesù Hospital, University of Roma La Sapienza, Hopital Universitaire Robert-Debre
- Responsible party
- Principal investigator, Oren Ledder, MD, Shaare Zedek Medical Center
- Investigators
- Oren Ledder, Principal investigator, Department of Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803916
- Sponsor's protocol ID
- Inflammation following EBD
- Status last verified
- May 2025
- First submitted
- 31 Aug 2020
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-stenotic Inflammation Following Endoscopic Balloon Dilatation in Crohn's Disease: A Prospective Study
- ClinicalTrials.gov ID
- NCT04803916
- Acronym / sponsor ID
- Inflammation following EBD
- Conditions
- Crohn Disease
- Keywords
- Crohn, Stricture, Endoscopic Balloon Dilatation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Collaborators
- Sheffield Children's NHS Foundation Trust, Bambino Gesù Hospital, University of Roma La Sapienza, Hopital Universitaire Robert-Debre
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 18 Mar 2021 (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.
As a consequence of chronic relapsing inflammation in Crohn's disease (CD), progressive bowel damage and scarring occurs in affected regions of intestine. This damage often leads to narrowing, or stricturing of the bowel lumen, and even complete bowel obstruction. Stricturing CD is thought to be a major contributor to penetrating complications including abscesses and fistulae.
Depending on the severity and clinical significance of fixed strictures, treatment options include either endoscopic balloon dilatation (EBD), or surgery with either resection or stricturoplasty recommended on a case-by-case basis.
EBD has been shown to be a safe alternative to surgery in management of CD strictures.
While the short- and medium-term clinical outcomes of EBD have been well described, less well studied is the impact of relieving Crohn's strictures on the inflammatory load proximal to the stricture. The restricted flow of fecal contents through a stricture creates a region of relative stasis in the bowel loops immediately proximal to the stricture, appreciated at times by pre-stenotic dilatation on cross-sectional imaging. This stasis fosters localized bacterial overgrowth and worsening dysbiosis in these bowel loops.
The investigators hypothesize that improvement of fecal flow by way of successful balloon dilatation of a CD stricture, could independently reduce the inflammatory burden, not only in the stenotic segment but also in the proximal loop of bowel.
Detailed description
This prospective, observational study will include both pediatric and adult patients with stricturing CD on stable therapy who are planned to undergo EBD for management of a Crohn's stricture.
Included patients are those in whom the treating physician is planning a colonoscopic EBD for a CD stricture. Patients will be followed with imaging, clinical assessment, serologic testing, stool microbiome and endoscopic assessment at time of EBD, and post-EBD. EBD will be performed to a target dilatation size of 18-20mm. If the stricture is deemed too narrow to allow dilatation to target size in a single session, graduated dilatations at a number of sessions can be undertaken at the treating clinician discretion. Time-point of week 0 will be defined as achievement of dilatation target size.
Clinical assessment, blood and stool for calprotectin and microbiome, and focused bowel US to be performed within a 4 week period prior to EBD. Previous imaging (US/MRE/CTE) from 2-4 months prior to EBD, where performed, will also be assessed.
In the absence of any contra-indication, repeat colonoscopy will be performed at week 12 (±2 weeks) to assess stricture size and assess extent of mucosal inflammation at the stricture site and the pre-stenotic region. Follow-up clinical review with repeat blood tests, stool for calprotectin and microbiome and focused bowel US will also be performed at week 12 (±2 weeks).
Endoscopic images from pre-stenotic bowel loop and bowel US from week 0 and week 12 will be centrally read by two central readers blinded to the patient and stage. An average of pre-stenotic region SES-CD score and US-derived outcome measures from both readers will be recorded. Where available, imaging from 2-4 months pre-EBD, either US, MRE or CTE, will be assessed by the same central readers.
Patients in whom successful balloon dilatation was achieved (see definitions below) will be included in the primary analysis. Patients in whom dilatation was attempted but was not successful (see below) will also be followed and will be analyzed as control group.
Patient's medications are to remain unchanged throughout the follow-up period, including biologic type or dose, or addition of corticosteroids/nutritional therapy, unless the treating physician decides otherwise on clinical grounds, in which case the patient will be defaulted from analysis. Patients on corticosteroid or nutritional therapy at recruitment can continue to wean therapy as per clinician directive.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This prospective, observational study will include both pediatric and adult patients with stricturing CD on stable therapy who are planned to undergo EBD for management of a Crohn's stricture.
Key inclusion criteria (6 listed)
- Patients diagnosed with CD as per most recent international guidelines.
- Presence of strictured bowel (jejunal, ileal, colonic or ileocecal valve), either primary or anastomotic in nature, with prestenotic dilatation >2.5cm loop diameter as demonstrated on cross-sectional imaging (Magentic Resonance Enteroclysis (MRE), Computerized Tomography Enteroclysis (CTE) or ultrasound (US))
- Evidence of pre-stenotic inflammation defined as wall thickness ≥5mm on cross-sectional imaging, or pre-stenotic SES-CD ≥3.
- Planned EBD as per clinical management.
- Unchanged CD medications - 3 months no change in therapy including immunomodulators (thiopurines or methotrexate), biological therapies, corticosteroid therapy, or nutritional therapy with exclusive enteral nutrition (EEN) or partial enteral nutrition (PEN).
Key exclusion criteria (2 listed)
- Any patient deemed not appropriate for EBD by treating physician due to stricture- specific, or patient-specific reasons will not be included
- Change in therapy (dose or type) in the 3 months prior to planned EBD
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
Endoscopic response
Time frame: 12 weeks compared to week 0
Decrease in SES-CD in the pre-stenotic region of ≥ 3 at 12 weeks compared to week 0
12 secondary outcomes
Endoscopic healing
Time frame: week 12
Wall thickness
Time frame: week 12 compared to week 0
Limberg score US
Time frame: week 12 compared to week 0
Luminal diameter
Time frame: week 12 compared to week 0
Inflammed length
Time frame: week 12 compared to week 0
Obstructive score reduction
Time frame: week 12
Clinical remission
Time frame: week 12
Stool calprotectin
Time frame: week 12 compared to week 0
No treatment escalation
Time frame: week 12
Comparison of imaging and calprotectin
Time frame: week 12
Clinical remission
Time frame: week 12
Clinical remission
Time frame: week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Oren Ledder principal investigator
Department of Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel
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 Shaare Zedek Medical Center at 1 site in Israel.
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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 22 May 2025. 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 Israel. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oren Ledder, Dr. (+972-2-6666743, orenl@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopic response (time frame: 12 weeks compared to week 0). 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 22 May 2025.