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INPIC   

Title

Invasive Procedures In Cancer Pain


Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Other Closed Betsi Cadwaladr University Health Board

Purpose

Mesothelioma is a cancer of the mesothelium. The mesothelium is a thin membrane that lines the chest and abdomen and surrounds the organs in these areas. Approximately 1800 new cases of mesothelioma are diagnosed each year in England. The large majority of patients will die within a year of diagnosis and only a very small minority will survive five years. Patients often experience pain on one side of their chest as the cancer damages the tissues of the wall of the chest. In some cases the pain can be so severe that it responds poorly to even the strongest painkillers doctors can prescribe. In cases such as this, national guidelines recommend that patients should be able to have a procedure called a cordotomy to relieve their pain.

Cordotomy is a major procedure that involves severing the nerves in the spinal cord that carry the nerve signals from the area affected by the mesothelioma to the brain where these signals are felt as pain. There are reports that this procedure (when successful) can be a very effective form of pain relief. The procedure is available in some areas of the country but not others, and there is not much information to help doctors or patients decide whether the risks of having a cordotomy are worth the benefits it may offer.

The purpose if the INPIC study is to examine all the available evidence about the benefits and risks of cordotomy, and find out how many Hospitals and specialists are able to carry out this procedure. We are also using a research approach called the Consensus method to decide whether doctors should use cordotomy to treat the pain associated with mesothelioma, and at what point the procedure should be offered to patients.

The Study will be in five main stages

  • A systematic review of all published and unpublished literature
  • A screening questionnaire to determine the availability of the procedure in the UK and reveal which clinicians are referring patients for the service.
  • An initial consensus phase will measure the extent of agreement amongst clinicians toward cordotomy by asking them to score their opinions on certain statements. This exercise will be repeated over a number of rounds with statistical analyses fed back from the previous round each time. The intention being to gradually produce a consensus of opinion.
  • A subsequent consensus phase will follow a similar method to the one above but will use more specific statements.
  • Finally a nominal group technique will be carried out at a national study day. Champions will be assigned to each one of the treatment modalities for mesothelioma related pain and the experts will be able to score the options live, resulting in immediate feedback and debate. The overall aim of the study and the National Study Day is to produce draft guidelines for the place and use of cordotomy in mesothelioma-related pain management.



Trial Lead Organisations

Betsi Cadwaladr University Health Board

Chief investigator: Dr Matthew Makin, Wrexham Maelor Hospital


Trial Start Date

Trial Not Open


Trial Coordinator

Gary Jeffers


Trial Coordinator Email Address

gary.jeffers@liverpool.ac.uk


Trial Coordinator Contact No

0151 794 8248