The National Institute for Health and Clinical Excellence is examining photodynamic therapy for bile duct cancer and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about photodynamic therapy for bile duct cancer.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the preliminary recommendations
• the identification of factual inaccuracies
• additional relevant evidence.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows:

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual).

Closing date for comments: 26 April 2005
Target date for publication of guidance: July 2005

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Current evidence on the safety and efficacy of photodynamic therapy (PDT) for bile duct cancer does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research.

Clinicians wishing to undertake PDT for bile duct cancer should take the following actions.

• Inform the clinical governance leads in their Trusts.
• Ensure that patients understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. Use of the Institute's Information for the public is recommended.
• Audit and review clinical outcomes of all patients having PDT for bile duct cancer.

When cancer develops in the bile duct, 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 from biliary obstruction such as jaundice, itchy skin, abdominal discomfort, loss of appetite, weight loss and fever. Photodynamic therapy is a palliative treatment option for bile duct cancer.

Treatment options depend on the stage, size, position and type of 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. The benefits of other palliative treatments such as radiotherapy, chemotherapy and brachytherapy are still being investigated.

Photodynamic therapy produces localised tissue necrosis by applying a photosensitising agent that is absorbed into the tumour tissue and then exposing the area to laser light of an appropriate wavelength.

A randomised controlled study of 39 patients reported that those treated with PDT and biliary stenting had a significantly longer median survival time than patients treated with biliary stenting alone (493 days versus 98 days, p < 0.0001). This study was terminated prematurely because PDT was so superior to stenting alone. Several quality of life scores were significantly improved after PDT, including global quality of life, fatigue, itching and weight loss. No significant improvements in quality of life scores were reported for the patients receiving biliary stenting alone. A non-randomised study of 44 patients reported that the mean survival after PDT and biliary stenting was 16 months, compared with 12.5 months after biliary stenting alone. For more details, refer to the sources of evidence (see Appendix).

Three studies reported 30-day mortality, which ranged from 0% (0/24) to 17% (1/6).

The Specialist Advisors stated that potential adverse effects included uncontrollable haemorrhage, bile leakage, gas embolism, deep vein thrombosis and infection. 2.4.2 The most common complications were cholangitis, affecting between 15% (3/20) and 56% (13/23) of patients, and photosensitivity, which was reported in 0% (0/8) to 33% (2/6) of patients. Other reported complications included bilioma, cholecystitis, stenosis, and haemobilia. For more details, refer to the sources of evidence (see Appendix).

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

Interventional procedures overview of photodynamic therapy for bile duct cancer, October, 2004

Available from: www.nice.org.uk/ip273overview