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

NCT07680283 | Recruiting FDA Device

• 1 other identifier: 26-491
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• feasibility in ultrasound assessment of resection margin

  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.

  Intraoperative / day of surgery

Secondary Outcomes (1)

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

  6 to 12 months

Study Arms (2)

IOUS-guided margin selection "Margin B"

EXPERIMENTAL

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.

Device: IOUS-guided margin selection

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.

Interventions

IOUS-guided margin selection DEVICE

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

IOUS-guided margin selection "Margin B"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Margins of Excision

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Associate Professor

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 2, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)