Recruiting

IOUS-guided Selection

Sponsor:

The Cleveland Clinic

Code:

NCT07680283

Conditions

Crohn's Disease (CD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IOUS-guided margin selection

Study Details

Brief 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.

Conditions

Crohn's Disease (CD)

Study ID

NCT07680283

Start date

Sep, 2026

Status verified date

Aug, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

22 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

IOUS-guided margin selection

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

Primary outcome measure

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

Central Contacts and Locations

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Monica Branche

216-445-6570BRANCHM2@ccf.org

Principal Investigator:

Anthony de Buck van Overstraeten, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Ultrasound
  • ileocecal resection
  • anastomosis
  • resection margin
  • ileocolic resection
  • Crohn's disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-08-27.