GLiSten: 5-ALA in Bowel Cancer Surgery - Development Phase

• Research type

  Research Study

• Full title

  GLiSten: Next generation intraoperative lymph node staging for stratified colon cancer surgery- Development Phase

• IRAS ID

  103369

• Contact name

  David Jayne

• Sponsor organisation

  University of Leeds

• Eudract number

  2012-002623-15

• ISRCTN Number

  N/A

• Research summary

  Colorectal cancer is the third most common cancer in the UK (41,142 new cases per annum), representing a substantial burden on healthcare resources. Surgery remains the only curative option. Currently, the standard approach is to remove the cancer along with its draining lymph nodes in order to reduce the risk of disease recurrence. There is emerging evidence that radical surgery, removing more lymphatic tissue, may improve survival. However, this will only benefit patients where the disease has spread to the lymph nodes. As the majority of patients with colon cancer (75%) do not have lymph node disease, they will not benefit from radical surgery and may in fact be exposed to unnecessary risk. An accurate method for real-time intraoperative lymph node assessment is required to tailor surgery to the stage of disease. The GLiSten study investigates the use of the photosensitiser, 5-amino levulinic acid (5-ALA), to detect lymph node metastases. 5-ALA is selectively taken up by cancer cells anfluresces red when viewed with blue-violet light. Patients undergoing elective surgery for right or sigmoid colon cancer suitable for laparoscopic surgery including those with metastatic disease with be invited to take part. Participants will take an oral solution of 5ALA before undergoing surgical resection. Areas oflurescence will be marked with surgical clips and specimens will be histologically scrutinised to determine the ability of 5-ALflurescence to diagnose the presence or absence of lymph node metastases. The project includes a development phase in two hospitals (Leeds and Dublin) to optimise techniques, followed by an evaluation phase (outlined in separate protocol and application) involving further centres with laparoscopic cancer expertise. If successful, it will enable a step-wise change in the surgical management of colon cancer, with surgery being individualised according the stage of the patient's disease, rather than the current "one-size-fits-all" approach.

• REC name

  London - South East Research Ethics Committee

• REC reference

  13/LO/0214

• Date of REC Opinion

  20 Mar 2013

• REC opinion

  Further Information Favourable Opinion