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

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What is this study about?

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.

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.

2 pre-surgery preparation

Before surgery, preparation involves standard preoperative procedures. No specific additional steps related to the trial are required at this stage.

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.

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.

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 Study?

  • 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.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Centr Georges Francois Leclerc Dijon France
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier William Morey Chalon Sur Saone France
Clinique Tivoli Ducos Bordeaux France
Hopital Europeen Marseille Marseille France
Clinique De La Sauvegarde Lyon France
Hopital Saint Joseph Marseille France
Hopital NOVO Pontoise France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Sante Atlantique Saint-Herblain France
Cpvarw Hwsphzgobcg Ukijtzezrzqiy Rtrjl Reims France
Cyu ddbucxdpnxyyxi Epagny Metz Tessy France
Coinsd Haznouchivb Uvzowwaovqaaf Dc Dgxqs Dijon France
Abzejslgsq Prkudapf Hjhvbmod Dp Mtarnmmvz Marseille France
Bzqrzsld Uqcoldywye Hbqzxibs Czywln Besançon France
Cdeoph Hoccevcijzi Rzjelseg Uyqbaozchdyix Dg Tkfzv Tours France
Gpffpn Haacydojxag Uxzaqcvtaeazu Poctt Ptvqoxpmfiq Er Nztkvyyrbuju Paris France
Iacovekk Pgpeqfrsbddrazl Cumcsd Chewjt Marseille France
Cxzims Ozbjn Lvopmba Lille France
Hzvpoqwv Uffkkwoveznfdy Sfaiznbamz &eyqcec Hhdzqch dn Hzevrdsuvit STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
26.09.2022

Trial locations

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.

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.

Trial ID:
2024-515118-42-00
NCT ID:
NCT05168839
Trial Phase:
Human Pharmacology (Phase I) – Other

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