Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal CD

NCT07680283 — Not applicable, Recruiting, 22 participants, The Cleveland Clinic

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Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal Crohn's Disease: A Phase II Randomized Trial

Registry	NCT07680283, acronym SMILE-CD
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	22 (Estimated)
Sponsor	The Cleveland Clinic (Other)
Conditions	Crohn's Disease (CD)
Interventions	IOUS-guided margin selection (Device)
Dates	start 2026-09-01 (estimated), primary completion 2028-08-01 (estimated), completion 2029-01-01 (estimated), first posted 2026-07-02, last updated 2026-08-27
Locations	1 site in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
IOUS-guided margin selection "Margin B"	Experimental	Device: IOUS-guided margin selection	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.
Macroscopic margin selection "Margin A"	No intervention		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.

IOUS-guided margin selection (Device): Intra-operative ultrasound (IOUS)-guided proximal resection margin selection during ileocolic resection for terminal ileal Crohn's disease

+Outcome measures

Primary outcomes

feasibility in ultrasound assessment of resection margin [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 outcomes

Comparison of histologic inflammation within the IOUS arm at 6 to 12 months [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.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Adults aged ≥18 years.
* 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.
* Scheduled to undergo primary ileocolic resection.

Exclusion Criteria:

* Penetrating disease with abscess or complex fistula requiring complex resection.
* Prior ileocolic resection.
* Diagnosis of Crohn's colitis.
* Pregnancy or inability to provide informed consent.
* 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.
* Contraindication to IOUS (as determined by the surgeon).

+Locations (1)

Facility	City	Country	Status
Cleveland Clinic	Cleveland, Ohio	United States	Recruiting

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