BioStent

• Research type

  Research Study

• Full title

  The BioStent study: Biodegradable oesophageal stents plus radiotherapy in carcinoma of the oesophagus

• IRAS ID

  107202

• Contact name

  Andrew Jackson

• Contact email

  andrew.jackson@uhs.nhs.uk

• Sponsor organisation

  University Hospital Southampton NHS Foundation Trust

• Research summary

  The commonest symptom of oesophagus (gullet/food pipe) cancer is difficulty swallowing due to blockage of the oesophagus by cancer. Patients unsuitable for curative treatment can have a wire mesh tube (metal stent) inserted to open up the oesophagus, quickly improving swallowing. Metal stents have side effects including pain and back flow of stomach contents. They can slip, become blocked, and may require removal or replacement. We therefore need to explore alternative treatments.

  Radiotherapy (high energy X-ray treatment) can improve swallowing, often for longer than stents, but improvement in swallowing is slower to start following radiotherapy, and swallowing may worsen at first.

  Biodegradable oesophageal stents are placed like metal stents but dissolve within 3-4 months. They are currently used for non-cancerous causes of oesophageal narrowing but not malignant disease. The placement of a biodegradable stent followed by a short course of radiotherapy may give both quick (from the stent) and longer-term (from radiotherapy) relief of swallowing problems and avoid some of the side effects associated with metal stents.
  We aim to test the effectiveness of biodegradable stents plus radiotherapy in patients with swallowing problems from incurable oesophagus cancer.

  Patients will be invited to have a biodegradable stent placed instead of a metal stent, then have a 1-2 week course of radiotherapy. We would consider the treatment promising if no more than 15% of patients require another procedure to help their swallowing within 4 months of this treatment. We will also ask patients about symptoms (particularly swallowing), their quality of life, their diet and their mood.

  We will conduct a qualitative sub-study (process evaluation) to evaluate participants' experiences of the intervention, study processes and day-to day life following insertion of the biodegradable stent.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  14/LO/0389

• Date of REC Opinion

  12 Jun 2014

• REC opinion

  Further Information Favourable Opinion