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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT07680283
Status
Recruiting
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Conditions

  • Crohn's Disease (CD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.
  • 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.

Primary Outcome Measure

feasibility in ultrasound assessment of resection margin [ Time Frame: Intraoperative / day of surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Monica Branche
[email protected]
216-445-6570
Anthony de Buck van Overstraeten, MD (PRINCIPAL_INVESTIGATOR)

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