Feasibility of sentinel lymph node biopsy in rectal cancer

• Research type

  Research Study

• Full title

  Feasibility study of sentinel lymph node biopsy in rectal cancer

• IRAS ID

  155425

• Contact name

  Christopher Cunningham

• Sponsor organisation

  Buckinghamshire NHS Trust

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  One issue in managing rectal cancer is identifying which patients will benefit from less radical surgery, which is much safer and better tolerated. However it does not remove lymph nodes where cancer cells may have spread. If lymph nodes containing cancer are left behind, the cancer may recur. So this surgery is only suitable in early rectal cancers not involving lymph nodes. Unfortunately, current investigations do not always accurately identify involved lymph nodes.
  Sentinel lymph node biopsy (SLNB) is a technique to surgically remove the first lymph node where cancer cells spread. If this lymph node contains cancer, radical surgery is needed to reduce the risk of recurrence. However if it is clear, less radical surgery should be sufficient. This is standard practice for breast cancer and avoids unnecessary major surgery in many patients.
  We aim to assess whether SLNB is useful in rectal cancer. We will investigate whether the Sienna+/Sentimag system effectively identifies the sentinel lymph node, and whether the node can then be removed surgically.
  We will recruit patients in Oxford hospitals about to undergo surgery for rectal cancer. Patients will receive an injection of magnetic tracer during endoscopy prior to surgery. Some patients will have an extra MRI scan. During or after surgery, depending on the type of operation planned, a magnetic probe will be used to locate the sentinel lymph node in the tissue around the rectum. The removed specimen will be examined by a pathologist. Funding to undertake this study has been granted by NIHR. Endomagnetics, the manufacturer, will supply the magnetic tracer and probe for use in this study.
  If successful, we will plan a larger clinical trial. This could have a major impact on improving outcomes for patients by allowing less radical surgery to be used where it is most appropriate.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  15/SC/0317

• Date of REC Opinion

  15 Jun 2015

• REC opinion

  Favourable Opinion