NCT07680283Recruiting
Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal CD
Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal Crohn's Disease: A Phase II Randomized Trial
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- First submitted
- 22 Jun 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- The Cleveland Clinic
- Diseases
- Crohn's disease
- NCT number
- NCT07680283
What you commit to
- Study type: Interventional
- Planned participants: 22
- From 1 Sept 2026 to the primary completion date, 31 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior ileocolic resection.
Other illness
- Penetrating disease with abscess or complex fistula requiring complex resection.
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.