The National Institute for Health and Clinical Excellence (NICE) issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on photodynamic therapy for bile duct cancer in July 2005. In accordance with the Interventional Procedures Programme Process Guide, guidance on procedures with special arrangements are reviewed 3 years after publication and the procedure is reassessed if important new evidence is available.
The guidance was considered for reassessment in July 2008 and it was concluded that NICE will not be updating this guidance at this stage. However, if you believe there is new evidence which should warrant a review of our guidance, please contact us via the email address below.
If cancer develops in the biliary tract, it may prevent bile flowing from the liver to the intestine. Early cancers are often asymptomatic but as the disease advances patients may experience symptoms such as jaundice, itchy skin, abdominal discomfort, loss of appetite, weight loss and fever.
Treatment options depend largely on the stage, size, position and type of the cancer. Bile duct cancer is not usually diagnosed before the symptoms of biliary obstruction occur, by which time the cancer may be too advanced for curative surgical resection. The standard options for palliative treatment include surgical bypass of the bile duct or the insertion of a stent using surgical, endoscopic or percutaneous techniques.
Photodynamic therapy (PDT) produces localised tissue necrosis by applying a photosensitising agent and then exposing the area to laser light of an appropriate wavelength. A photosensitising agent is used that preferentially accumulates in the tumour tissue rather than normal tissue.
Photodynamic therapy is usually administered in conjunction with a biliary stenting procedure. The photosensitising agent is injected intravenously and photoactivation is performed approximately 48 hours later. This is done by inserting a laser through a catheter situated close to the tumour or by placing the laser directly across the tumour. Patients remain in the dark for about 3 days after injection and are then gradually readapted to light.
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.