Study on Using Fluorescein Sodium to Identify Inflammation in Crohn’s Disease Patients During Ileal Surgery

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What is this study about?

This clinical trial focuses on studying Crohn’s disease, specifically the type that affects the ileum, which is the last part of the small intestine. The study is investigating a treatment involving an intravenous injection of fluorescein sodium, a substance that helps doctors see inflammation more clearly during surgery. The treatment is used alongside a device called Cellvizio, which helps visualize the inside of the body in real-time during surgery.

The purpose of the study is to determine if using Cellvizio with fluorescein sodium can help surgeons identify the best areas to remove during surgery for Crohn’s disease. This is important because it can help ensure that the parts of the intestine that are removed are the ones most affected by the disease, potentially leading to better outcomes for patients.

Participants in the study will receive the fluorescein sodium injection during their surgery. The study will compare the results from the Cellvizio images with traditional pathology methods to see if they match in identifying inflammation. The study will also look at how well the Cellvizio images can identify inflammation in different layers of the intestine and how much of the intestine needs to be removed to ensure a non-inflammatory area is reached.

1 joining the study

Participation begins after meeting the inclusion criteria: being an adult aged 18 or older and having end-stage ileal Crohn’s disease that requires ileocaecal resection.

2 preparation for surgery

Before the surgical procedure, preparation involves understanding the use of the Cellvizio device and the administration of fluorescein sodium.

Fluorescein sodium is administered as an intravenous injection. This is a solution for injection known as FLUOCYNE 10%.

3 surgical procedure

During surgery, the Cellvizio device, equipped with the CelioFlex microsonde, is used to assess the ileal resection margins.

The main objective is to determine the best resection margins by evaluating the microscopic inflammation at the ileal section.

4 evaluation of results

The primary endpoint is to assess whether the ileal mucosal section margin is healthy or inflamed using Cellvizio and pathology.

Secondary endpoints include evaluating the concordance between Cellvizio and pathology for inflammation of the serosa and mesentery, and measuring the length of the ileum between the surgical margin and the theoretical resection site.

5 completion of study participation

The study is estimated to conclude by October 31, 2025. Participation ends after the surgical procedure and evaluation of results.

Who Can Join the Study?

Must be an adult who is at least 18 years old.
Must have end-stage ileal Crohn’s disease. This means the disease has progressed to a severe stage affecting the ileum, which is the last part of the small intestine.
Must require a surgical procedure called ileocaecal resection. This is an operation to remove the affected part of the intestine.
Both men and women can participate.
Participants should not belong to a vulnerable population, meaning they should not be in a group that needs special protection or care.

Who Cannot Join the Study?

Patients who do not have Crohn’s ileal disease cannot participate. This is a condition affecting a part of the small intestine called the ileum.
Patients who are not within the specified age range cannot participate. The age range includes certain age groups, but specific ages are not provided here.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	31.10.2023

Trial locations

Investigated drugs:

Fluorescein Sodium

Cellvizio is a medical imaging device used during surgery to help doctors see inside the body in real-time. In this trial, it is used with a special probe called the CelioFlex microsonde to help identify the best areas to remove in patients with Crohn’s disease affecting the ileum.

Fluorescein is a dye that is injected into the bloodstream. It helps highlight areas of inflammation or disease when viewed with certain imaging devices, like the Cellvizio, during surgery. This helps doctors make more precise decisions about which parts of the intestine to remove.

Investigated diseases:

Crohn's disease

Crohn’s Ileal Disease – Crohn’s ileal disease is a type of inflammatory bowel disease that primarily affects the ileum, which is the last part of the small intestine. It is characterized by chronic inflammation that can lead to symptoms such as abdominal pain, diarrhea, and weight loss. The inflammation can cause the intestinal walls to thicken, leading to blockages and other complications. Over time, the disease can progress with periods of flare-ups and remission. The exact cause of Crohn’s ileal disease is not fully understood, but it is believed to involve a combination of genetic, environmental, and immune system factors. The condition can vary greatly in severity and may affect other parts of the digestive tract.

Trial ID:

2024-517220-19-00

Protocol code:

PI2022_843_0111

NCT ID:

NCT05805020

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Using Fluorescein Sodium to Identify Inflammation in Crohn’s Disease Patients During Ileal Surgery

What is this study about?

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