A new technique to help ensure the bowel heals properly following cancer surgery is to be assessed in an international clinical trial, with support from the HTC.
One of the most dangerous complications following removal of cancerous sections of the bowel is an anastomotic leak, when joins in the bowel fail to heal, allowing faecal material to leak out. One in five patients die as a result of anastomotic leaks; those that survive can also suffer wound complications, permanent stoma and an increased risk of the cancer recurring. Rectal surgery brings the highest risk of anastomotic leak.
One of the key factors in enabling a join to heal is the quality of the blood supply to that area. The new technique, called intraoperative fluorescent angiography (IFA), involves injecting a fluorescent molecule into the blood stream during surgery, which allows the blood supply to the bowel to be made visible using a near-infrared camera. Surgeons can then make the join between areas of the bowel that are well supplied with blood to promote healing.
The technique has undergone proof of concept trials, with only two out of 147 patients who underwent rectal cancer surgery using IFA subsequently suffering an anastomotic leak. This is a significant reduction from the 10-15 percent of patients who suffer a leak following standard surgery.
The use of IFA is now to be rigorously evaluated in a multi-centre trial involving 320 patients undergoing surgery for rectal cancer, recruited at 15 centres in the UK and 15 centres in other countries across Europe. The trial is being led by HTC Clinical Director, Professor David Jayne and coordinated by the University of Leeds Clinical Trials and Research Unit. The HTC will play a pivotal role by providing public and patient involvement and trial promotion. The trial is being funded jointly by the Medical Research Council and the National Institute for Health Research, under their Efficacy and Mechanism Evaluation (EME) Programme.
Patients will be randomly assigned to receive surgery either with or without IFA. As well as monitoring the number of subsequent anastomotic leaks, the trial will look at any other complications that occur, including postoperative bowel function, quality of life and the amount of health resources used. A sub-study of 75 patients will undergo additional CT angiography and CT scans to assess rectal blood supply, to enable assessment of how variations in vascular anatomy and rectal blood supply affect the use of IFA and surgical decision-making.