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NCT Number: NCT07680283

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

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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Key information

Conditions

Crohn's Disease (CD) Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Margins of Excision Morphological and Microscopic Findings Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Anthony de Buck van Overstraeten, MD

PRINCIPAL_INVESTIGATOR

Monica Branche

CONTACT

[email protected]

216-445-6570

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

IOUS-guided margin selection

Device

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

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Acronym: SMILE-CD

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

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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