IntAct- IFA to prevent anastomotic leak in rectal cancer surgery
Research type
Research Study
Full title
IntAct: Intraoperative Fluorescence Angiography to Prevent Anastomotic Leak in Rectal Cancer Surgery
IRAS ID
216411
Contact name
Julie Croft
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
Summary of Research
Surgery for colorectal cancer can offer a cure, but is associated with complications and even death. One of the most serious complications is anastomotic leak (AL). This happens when a join in the bowel does not heal properly, causing faecal contents to spill into the abdomen. ALs cause patients to become very unwell and 1 in 5 do not survive. Those who do survive can go on to experience difficulties with wound healing, longer stays in hospital, the need for a stoma (a bag to collect faeces),and increased risk of cancer coming back. One way to reduce the risk of AL is to ensure that the bowel being joined has a good blood supply. Intraoperative fluorescent angiography (IFA) has recently been introduced to help with this. During IFA a drug is injected into the blood which fluoresces(glows) when viewed with a special camera. The blood supply to the bowel can then be seen and helps the surgeon to decide which part of the bowel to use for the anastomosis. The trial will recruit 880 patients from hospitals in Europe. Patients will be randomly allocated to either surgery with IFA or standard care (surgery without IFA). The rates of AL will be compared between the groups to see if IFA decreases leak rate. The trial will also look at complications, bowel function, patients’ quality of life,and value for money.Two sub-studies will be undertaken to better understand why some anastomoses leak. 75 UK patients will take part in the perfusion substudy and will undergo a preoperative CT scan to look at variations in blood supply to the bowel,how radiotherapy affects blood supply,and how this alters IFA assessment and surgical decision-making. 200 UK patients will also undergo evaluation of bacteria within the rectum (microbiome analysis) to see if there is a link with AL.Summary of Results
Why did we do this trial?
Bowel (colorectal) cancer is one of the most common cancers in the UK, causing 16,000 deaths each year. Surgery is required to remove the piece of bowel that contains the cancer, and then the two open ends of the bowel are joined together. One of the most serious complications is an anastomotic leak which happens when the join in the bowel does not heal properly. This can cause patients to become very unwell. Ensuring good blood supply to the bowel that is being joined can reduce the risk of an anastomotic leak. There is a new technology to assist surgeons called Indocyanine Green near infra-red angiography (ICG-NIR). During the operation, a dye is injected into the blood which glows and shows the blood supply to help the surgeons make decisions. We wanted to find out if using ICG-NIR reduces the number of anastomotic leaks.What did we do?
Between 2017 and 2023, 766 patients who needed an operation for rectal cancer agreed to take part in the IntAct trial. To allow a fair comparison of treatments, half the patients were randomised to have a standard operation (surgery without ICG-NIR), and the other half were randomised to have their operation with ICG-NIR.What did we find and what does this mean?
The IntAct trial has shown that the use of ICG-NIR during surgery reduces the rate of most types of anastomotic leaks, but did not change how often the worst leaks occurred. Using IFA helped surgeons to better choose which parts of the bowel to join, which helped prevent anastomotic leaks from happening. Reducing the risk of anastomotic leaks means that less patients will become unwell after having an operation for rectal cancer and overall cancer outcomes will improve.REC name
North West - Preston Research Ethics Committee
REC reference
17/NW/0193
Date of REC Opinion
20 Apr 2017
REC opinion
Further Information Favourable Opinion