Lymphatic mapping for sentinel node identification and analysis

• Research type

  Research Study

• Full title

  A study to assess near infrared laparoscopy with indocyanine green (ICG) for intraoperative lymphatic imaging and sentinel lymph node identification during standard surgical resection for colonic cancer

• IRAS ID

  88823

• Contact name

  Robin Kennedy

• Eudract number

  2012-000424-18

• Research summary

  Early diagnosis of colorectal cancer (CRC), our third commonest cancer and second highest cause of cancer death, is likely to become more common since the introduction of the National Bowel Cancer Screening Programme and increased patient and physician awareness. Data published from screening centers demonstrate a significant shift towards earlier stage disease in the screened population, suggesting that in future, up to 50% of cancers detected through screening will be localised within the bowel wall (Stage I) compared to the current 10%. In addition, in those tumours that are relatively small (T1 and T2 tumours), approximately only 15% have tumour present in the regional lymph nodes that drain the area. Current radiological techniques (CT scan, MRI or ultrasound) are not sensitive enough to accurately identify this small group of patients before surgery. Instead, a major operation is performed in order to remove the segment of the bowel bearing the early cancer and regional lymph nodes regardless of the stage of the disease. Microscopic examination of these lymph nodes has to be performed on every patient, as the presence of cancer cells in lymph nodes remains the most important factor in determining whether subsequent chemotherapy is necessary. Therefore at present, over 85% of patients with T1 and T2 cancers (approximate number ~3000/year) who are node negative, have surgery receiving no additional benefit from removal of these lymph nodes and are subject to a long hospital stay (mean 9 days) with significant short and long-term complications. Over the recent years, efforts have been made to develop localized excision techniques, combining endoscopy and minimal access laparoscopy, which would allow us to avoid major surgery in patients in such patients. Unfortunately, using the current diagnostic techniques, we are unable to accurately identify these patients. The aim of this study is to determine whether the first draining lymph nodes from the cancer site can be identified during surgery using advanced technology. We will then establish whether the presence or the absence of cancer cells in the first order lymph nodes is comparable to that of all the lymph nodes in resected specimen (bowel containing the tumour and the mesentery). If this is proven to be the case, it would potentially transform the surgical care of patients with early colon cancer. Patients with no cancer spread to the local lymph nodes could be offered a less invasive and a more personalized surgery.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  12/LO/1406

• Date of REC Opinion

  26 Oct 2012

• REC opinion

  Favourable Opinion