Is There a Concordance Between Cellvizio Imaging With Fluorescein Injection and Pathology to Determine Microscopic Inflammation at Ileal Resection Margins in Crohn's Ileal Disease

What this Trial Is About

Crohn disease is an inflammatory bowel condition that often requires surgery, affecting about 80% of patients. Although surgery does not cure Crohn disease, how the surgery is performed is important because certain risk factors during the operation can lead to disease recurrence. One key factor is microscopic inflammation at the edges of the tissue removed, which can increase the chances of the disease returning. Surgeons aim to remove enough tissue to avoid inflammation while preserving as much as possible to prevent complications like short bowel syndrome. This study focuses on using a new imaging method called Cellvizio to better identify these inflammation margins during surgery. Cellvizio is a confocal laser endomicroscopy tool that provides high-magnification, real-time images of the gut lining at a cellular level. In this study, patients undergoing ileal resection surgery for Crohn disease will receive an intravenous injection of fluorescein, a dye that helps highlight tissues. The surgeon will use Cellvizio to examine the mucosa, serosa, and mesentery at the resection margins to see if there is microscopic inflammation. The length between the observed inflammatory margin and the expected non-inflammatory margin will be measured during surgery. The study collects this data during the operation, separate from later pathological analysis, to evaluate how well Cellvizio images match with lab results. Participants in this trial will undergo standard ileocaecal resection surgery for Crohn disease with the addition of Cellvizio imaging during the operation. The study will compare the Cellvizio images with pathology results over two years to determine concordance. Data is collected anonymously and includes videos of the imaging. The goal is to improve surgical precision by identifying the best tissue margins to reduce disease recurrence. Participants will be closely monitored throughout the trial, which is expected to continue until March 2026.

Cellvizio to Evaluate Margins in Crohn's Ileal Disease