Crohn's Disease (CD)
Ultrasound-Guided Surgical Margins for Terminal Ileal Crohn's Disease
This single-center randomized study is investigating whether intra-operative ultrasound can feasibly guide the proximal resection margin in adults undergoing ileocolic surgery for terminal ileal Crohn's disease, compared with standard visual and tactile margin selection.
Registry title: Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal CD
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years and older
- Treatment
- IOUS-guided margin selection
- Design
- Randomized
- Sponsor
- The Cleveland Clinic
Research question
Can intra-operative ultrasound feasibly identify a proximal surgical margin meeting the study's ultrasound criteria during ileocolic resection for terminal ileal Crohn's disease?
Participant snapshot
Who the study is looking for
- The study is looking for adults age 18 or older.
- Participants must have terminal ileal Crohn's disease with an inflammatory or fibrostenotic phenotype localized to the terminal ileum or ileocecal region.
- Participants must be scheduled for a first ileocolic resection.
- The study is recruiting at Cleveland Clinic in Cleveland, Ohio.
Participation overview
What participation may involve
Participants undergo a planned ileocolic resection. The assigned group determines whether the proximal margin is selected using intra-operative ultrasound criteria or the surgeon's standard visual and tactile assessment. What participation may involve: - Undergo the planned ileocolic resection for terminal ileal Crohn's disease. - Have the proximal resection margin selected using either intra-operative ultrasound guidance or standard visual and tactile assessment, depending on randomized assignment. - Provide surgical-margin tissue for histologic assessment comparing inflammation within and between study groups. - The registry identifies an endoscopic-recurrence endpoint, but does not clearly describe the associated assessment schedule or procedures.
Study interventions
What participants may receive or do
- IOUS-guided margin selection: During ileocolic surgery, intra-operative ultrasound (IOUS) is used after the surgeon selects an initial margin to guide selection of a proximal resection margin. The ultrasound-guided margin must have bowel-wall thickness of 2.5 mm or less and preserved wall stratification.
Study design
How the comparison works
This is a Phase II, single-center, two-group study planning to randomly assign 44 participants to ultrasound-guided or standard surgical margin selection during ileocolic resection. Assignment is randomized and computer-generated, with concealed allocation using permuted blocks to balance group sizes. The narrative states that participants and outcome assessors will be blinded but surgeons cannot be; however, the structured design field reports no masking. This discrepancy needs clarification. The comparison group receives standard margin selection, in which the surgeon chooses the proximal transection site using visual and tactile assessment of the bowel.
Reported activities
Procedures and tests
- Ileocolic resection is the surgery participants are already scheduled to undergo.
- In the ultrasound-guided group, intra-operative ultrasound measures bowel-wall thickness and assesses preservation of bowel-wall stratification.
- In the standard group, the surgeon selects the margin through visual and tactile assessment of the bowel.
- Surgical-margin tissue is assessed for histologic inflammation, with comparisons involving the initial, ultrasound-guided, and distal margins where applicable.
- Screening may involve confirming the disease location and inflammatory or fibrostenotic phenotype from preoperative imaging or findings during surgery.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be adults age 18 or older.
- Participants must have terminal ileal Crohn's disease with an inflammatory or fibrostenotic phenotype localized to the terminal ileum or ileocecal region.
- The required disease features must be assessed through preoperative imaging or during surgical exploration.
- Participants must be scheduled for a first ileocolic resection.
Possible reasons someone may not be able to join
- People with penetrating disease involving an abscess or complex fistula that requires complex resection are excluded.
- People who previously had an ileocolic resection are excluded.
- People diagnosed with Crohn's colitis are excluded.
- Pregnant people and people unable to provide informed consent are excluded.
- If a stoma is found to be required before randomization, the person will not be randomized and will be excluded.
- A person remains in the trial if a stoma is created after randomization, but will not be evaluated for the endoscopic-recurrence endpoint.
- People whose surgeon determines that intra-operative ultrasound is contraindicated are excluded.
Important unknowns
What the record does not make clear
- The registry does not state how many study visits are required or when they occur.
- The total duration of participation for an individual is not reported.
- The registry does not explain whether Crohn's disease medicines continue, pause, or change before or after surgery.
- No medication washout requirements are provided.
- The registry does not describe rescue treatment or how postoperative Crohn's disease recurrence would be managed.
- The eligibility text mentions an endoscopic-recurrence endpoint, but the registry does not describe whether or when participants undergo endoscopy.
- The registry does not identify which surgical, research, imaging, pathology, or follow-up costs are covered.
- Compensation for participation is not reported.
- Travel or lodging support is not reported.
- The narrative says participants and outcome assessors are blinded, while the structured design field reports no masking.
Before contacting the site
Questions for the study team
- How many research visits are required, and how long would participation last after surgery?
- Does the study require postoperative endoscopy or other imaging, and when would those assessments occur?
- Which Crohn's disease medicines may continue around surgery, and are any washout periods required?
- Who will know the assigned study group during surgery and follow-up?
- What happens if ultrasound cannot identify a qualifying margin within 30 minutes?
- What additional tissue, records, or follow-up assessments are collected for the histology and safety outcomes?
- Which costs are covered, and are compensation or travel support available?
Before changing care
Questions for your gastroenterologist
- Would any of my current Crohn's disease medicines need to change around this surgery or possible study participation?
- How stable is my disease, and how do my disease location and inflammatory or fibrostenotic phenotype relate to the planned operation?
- What approved surgical and medical alternatives should I understand before discussing this study with the research team?
- Are there risks from intra-operative ultrasound-guided margin selection that are especially relevant to my disease and surgical history?
- How would you coordinate my postoperative Crohn's disease treatment and monitoring with the Cleveland Clinic research team?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
This is a Phase II, single-center (Cleveland Clinic), two-arm, randomized, parallel-group superiority trial. The two arms will compare IOUS-guided margin selection against standard macroscopic margin selection in patients undergoing ileocolic resection for terminal ileal Crohn's disease. Patients and outcome assessors (pathologists, endoscopists) will be blinded to the intervention arm, while surgeons, by the nature of the intervention, cannot be blinded. Randomization will be computer-generated with concealed allocation using permuted blocks to ensure balanced group sizes.
Study design and administration
- Organization
- The Cleveland Clinic
- Organization class
- Other
- Organization study ID
- 26-491
- Lead sponsor
- The Cleveland Clinic
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
IOUS-guided margin selection "Margin B"
After the surgeon initially selects the macroscopic Margin A, IOUS will be performed to guide the selection of a proximal resection margin ("Margin B"). Margin B will be defined by specific IOUS criteria: mural thickness ≤ 2.5 mm and preserved stratification of the bowel wall.
Interventions: Device: IOUS-guided margin selection
No Intervention
Macroscopic margin selection "Margin A"
The proximal transection site of the ileocecal resection will be chosen by the surgeon based on gross visual and tactile assessment of the bowel ("Margin A"). This represents the current standard of care.
Interventions
Device
IOUS-guided margin selection
Intra-operative ultrasound (IOUS)-guided proximal resection margin selection during ileocolic resection for terminal ileal Crohn's disease
Eligibility
18 Years and older
All
Not accepted
Inclusion criteria (3)
- Adults aged ≥18 years.Registry-derived · unreviewed
- Diagnosis of terminal ileal Crohn's disease with inflammatory or fibrostenotic phenotype localized to terminal ileum/ileocecal region and assessed on either preoperative imaging or during surgical exploration at the time of surgery.Registry-derived · unreviewed
- Scheduled to undergo primary ileocolic resection.Registry-derived · unreviewed
Exclusion criteria (6)
- Penetrating disease with abscess or complex fistula requiring complex resection.Registry-derived · unreviewed
- Prior ileocolic resection.Registry-derived · unreviewed
- Diagnosis of Crohn's colitis.Registry-derived · unreviewed
- Pregnancy or inability to provide informed consent.Registry-derived · unreviewed
- Stoma at or before randomization: Participants in whom a stoma is required before randomization (identified intra-operatively) will not be randomized and will be excluded from the trial. Stoma after randomization: If a stoma is created after randomization-either during the index operation or at re-operation for postoperative complications-the participant remains in the trial. All feasibility, histopathology, operative, and safety outcomes will be collected and analyzed in the assigned arm (ITT). However, these participants will not be evaluable for the endoscopic-recurrence endpoint; they will be listed as "not assessed for endoscopic recurrence (stoma)" with reasons documented.Registry-derived · unreviewed
- Contraindication to IOUS (as determined by the surgeon).Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
feasibility in ultrasound assessment of resection margin
Time frame: Intraoperative / day of surgery
Feasibility, defined as the proportion of cases in which IOUS is successfully performed with a designated proximal margin (Margin B) in the IOUS arm, will be reported as a percentage with 95% confidence intervals. Feasibility will be declared if ≥ 75% of randomized patients in the IOUS arm achieve successful designation of Margin B. Failure will be defined as such: Technical inability to measure bowel wall thickness with ultrasound or to stratify the bowel wall stratification; failure to identify an appropriate margin within 30min; resection exceeding the additional length by 20cm in more than 20% of the cases.
Secondary outcome
Comparison of histologic inflammation within the IOUS arm at 6 to 12 months
Time frame: 6 to 12 months
Comparison of histologic inflammation within the IOUS arm (Margin A versus Margin B versus distal margin) will be performed using McNemar's test or Wilcoxon signed-rank test for paired data, as appropriate. Between-arm comparison of histologic findings (IOUS arm versus standard arm) will be performed using Chi-square test, Fisher's exact test, or Wilcoxon rank-sum test for unpaired comparisons.
Recruiting locations in the United States
Cleveland Clinic
RecruitingCleveland, Ohio, 44195, United States
Monica Branche216-445-6570BRANCHM2@ccf.org
Anthony de Buck van Overstraeten, MD
Registry dates
- First posted
- Jul 2, 2026
- Primary completion
- Jun 2028
- Overall completion
- Jan 2029
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.