Recruiting

Study on Indocyanine Green for Reducing Leakage in Colorectal Cancer Surgery Patients

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the use of a special imaging technique during surgery for patients with colorectal cancer. The trial involves a substance called indocyanine green, which is used to help surgeons see blood flow in tissues during operations. This technique is known as intraoperative fluorescence angiography. The main goal of the study is to see if using this method can help reduce the risk of a complication called anastomotic leakage, which can occur after surgery when the connection between two parts of the intestine leaks.

Participants in the study will undergo surgery for colorectal cancer, where the surgeons will use the indocyanine green to check the blood flow in the area where the intestines are joined together. This is done to ensure that the tissues are healthy and well-supplied with blood, which may help prevent leaks. The study will monitor patients for 90 days after their surgery to see if this method helps reduce complications.

Throughout the study, researchers will also look at other factors, such as any changes made during surgery based on the blood flow assessment, the need for additional procedures, and the overall recovery of patients, including their quality of life and time spent in the hospital. The study aims to provide valuable information on whether this imaging technique can improve outcomes for patients undergoing colorectal cancer surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after signing an informed consent form. Eligibility includes being scheduled for elective left colectomy or high rectal resection for cancer with intraperitoneal anastomosis, being over 18 years old, and being affiliated with the French social security system.
Step 2
Pre-surgery preparation
Before surgery, preparation involves standard preoperative procedures. No specific additional steps related to the trial are required at this stage.
Step 3
Surgery and medication administration
During surgery, an assessment of blood flow to the surgical site is performed using intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG).
ICG is administered as a solution for injection through an intravenous bolus. The product used is INFRACYANINE 25 mg/10 mL.
Step 4
Post-surgery monitoring
After surgery, monitoring for any complications, including anastomotic leakage, occurs over a 90-day period. This involves regular check-ups and imaging if necessary.
The primary focus is on detecting any leakage at the surgical site, which is defined as any dehiscence with leakage into the pelvic cavity or any isolated pelvic organ-space infection.
Step 5
Follow-up and evaluation
Follow-up includes evaluating changes in the planned surgical procedure, the rate of temporary stoma creation, overall complications, and any need for additional surgery within 90 days.
Quality of life is assessed using specific questionnaires at the start and 90 days after surgery. The economic impact of using IOFA with ICG is also evaluated.

Who can join the trial?

4 criteria

Must be scheduled to have a planned surgery called a left colectomy or high rectal resection for cancer. This involves removing part of the colon or rectum and connecting the remaining parts inside the abdomen.
Must have signed a document called an informed consent, which means you understand the study and agree to participate.
Must be part of the French social security system, including CMU, which is a type of health coverage in France.
Must be an adult, meaning you are over 18 years old.

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Verified sites

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Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Verified
Besancon University Hospital Center
Besançon, France
Responsive
Institut De Cancerologie De Lorraine
Vandoeuvre Les Nancy, France

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Investigated drugs

Indocyanine Green (ICG) is a dye used in medical imaging. In this trial, it is used during surgery to help doctors see blood flow in the tissues. This helps them check if the area where they are joining two parts of the intestine has good blood supply, which can help prevent complications after surgery.

Indocyanine Green

What is already known about the treatment

Indocyanine Green – This medication is administered intravenously and is used during surgery to visualize blood flow and tissue perfusion. It is currently being studied in clinical trials for its effectiveness in preventing complications during colorectal surgery, specifically to reduce anastomotic leakage. Indocyanine Green works by binding to plasma proteins and emitting fluorescence when exposed to near-infrared light, allowing surgeons to assess blood supply to tissues. It is classified as a diagnostic agent and is widely used in various medical fields for imaging purposes.

Investigated diseases

Colorectal cancer – This is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. As the disease progresses, it can invade and damage nearby tissues and organs. It may also spread to other parts of the body, such as the liver or lungs, through the bloodstream or lymphatic system. Symptoms can include changes in bowel habits, blood in the stool, abdominal discomfort, and unexplained weight loss.