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

2026年8月26日 更新者：Anthony de Buck van Overstraeten、The Cleveland Clinic

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

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

22

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Ohio
      • Cleveland、Ohio、美国、44195
        • 招聘中
        • Cleveland Clinic
        • 首席研究员：
          • Anthony de Buck van Overstraeten, MD
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
设备：IOUS-guided margin selection
Intra-operative ultrasound (IOUS)-guided proximal resection margin selection during ileocolic resection for terminal ileal Crohn's disease
无干预：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
feasibility in ultrasound assessment of resection margin
大体时间：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.
Intraoperative / day of surgery

次要结果测量

结果测量
措施说明
大体时间
Comparison of histologic inflammation within the IOUS arm at 6 to 12 months
大体时间：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.
6 to 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The Cleveland Clinic

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2028年8月1日

研究完成 (估计的)

2029年1月1日

研究注册日期

首次提交

2026年6月22日

首先提交符合 QC 标准的

2026年6月29日

首次发布 (实际的)

2026年7月2日

研究记录更新

最后更新发布 (实际的)

2026年8月27日

上次提交的符合 QC 标准的更新

2026年8月26日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 26-491

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared outside the Cleveland Clinic study team. Results will be reported in aggregate form in presentations and publications. This is a small single-center feasibility study, and the consent form does not include a plan for external sharing of de-identified individual participant-level data.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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