Endoscopic bipolar radiofrequency ablation for the treatment of malignant biliary obstructions from cholangiocarcinoma or pancreatic adenocarcinoma: consultation document
Interventional procedure consultation document
Endoscopic bipolar radiofrequency ablation for treating biliary obstruction caused by cholangiocarcinoma or pancreatic adenocarcinoma
Using radiofrequency energy to treat malignant bile duct or pancreatic duct obstructions caused by cholangiocarcinoma or pancreatic adenocarcinoma
Bile duct cancers and pancreas cancers can cause obstructions and block the ducts that carry digestive juices from the gall bladder and pancreas to the small intestine. This can cause a number of symptoms including jaundice, nausea, bloating and abdominal pain. Often this is treated by inserting small tubes called stents, which help to keep the ducts open and draining properly. However, these stents can become blocked and need replacing, which may be difficult. This procedure uses heat energy both to clear the duct obstructions before inserting stents, and to clear blocked stents.
The National Institute for Health and Care Excellence (NICE) is examining endoscopic bipolar radiofrequency ablation for treating biliary obstructions caused by cholangiocarcinoma or pancreatic adenocarcinoma and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of specialist advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about endoscopic bipolar radiofrequency ablation for treating biliary obstructions caused by cholangiocarcinoma or pancreatic adenocarcinoma.
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 provisional recommendations
- the identification of factual inaccuracies
- additional relevant evidence, with bibliographic references where possible.
Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.
The process that NICE 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 NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.
For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).
Through its guidance NICE is committed to promoting race and disability equality, equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.
In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:
Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations between people with a characteristic protected by the equalities legislation and others?
Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.
Closing date for comments: 21 June 2013
Target date for publication of guidance: September 2013
1 Provisional recommendations
1.1 Current evidence on the safety and efficacy on endoscopic bipolar radiofrequency ablation for treating biliary obstructions caused by cholangiocarcinoma or pancreatic adenocarcinoma is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research.
1.2 Further research, in the form of comparative or observational studies, should document details of patient selection and should report all adverse events. Outcomes should include survival, quality of life, biliary patency and the need for further procedures.
1.3 Clinicians should consider entering patients with pancreatic adenocarcinoma into the EndoHPB 1001 trial.
2 Indications and current treatments
2.1 Cholangiocarcinoma and pancreatic adenocarcinoma causing obstruction of the bile or pancreatic ducts causes symptoms resulting from obstruction of the flow of bile and pancreatic juice into the duodenum, including jaundice, nausea, bloating and abdominal pain. Surgical resection is often not possible.
2.2 Current management of unresectable cholangiocarcinoma and pancreatic cancer includes biliary stenting, done at endoscopic retrograde cholangiopancreatography (ERCP), chemotherapy, biological therapies (for example, monoclonal antibodies), radiation therapy and photodynamic therapy. Stents often need to be replaced because of blockage by tumour ingrowth.
3 The procedure
3.1 Endoscopic radiofrequency ablation uses heat energy to ablate malignant tissue that is obstructing the bile or pancreatic ducts. This may be done before inserting stents or to clear obstructed stents.
3.2 The procedure is done with the patient under sedation. ERCP with fluoroscopic guidance is used to establish the length, diameter and position of the stricture. Under endoscopic visualisation, a bipolar endoscopic radiofrequency ablation catheter is deployed over a guide wire across the stricture. Controlled pulses of radiofrequency energy delivered by a radiofrequency generator are applied to obstructing tumour tissue to ablate it and to allow insertion of a stent, and/or to clear the lumen of a previously placed stent. Sequential applications are applied throughout the length of the stricture in order to achieve recanalisation. Repeat treatments may be used if obstruction recurs.
This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.
4.1 A case series of 22 patients reported that deployment of an endoscopic radiofrequency ablation catheter was successful in 95% (21/22) of patients. The one unsuccessful deployment occurred because of irretrievable proximal migration of a previously placed plastic stent.
4.2 The case series of 22 patients reported that self-expandable metal stent placement was achieved after endoscopic radiofrequency ablation in 100% (21/21) of successful catheter deployments.
4.3 The case series of 22 patients reported that stent patency was maintained in 95% (20/21) of patients at 30 days follow-up (1 patient developed further biliary obstruction), and 76% (16/21) of patients at 90 days follow-up (2 had died, 3 developed further biliary obstruction).
4.4 The Specialist Advisers listed key efficacy outcomes as survival, stent patency, reduced occurrence of cholangitis, reduced need for further biliary intervention and quality of life.
This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.
5.1 Death within 90 days was reported in 10% (2/21) of patients in a case series of 22 patients. One patient died after biliary decompression by self-expandable metal stent placement could not be achieved and the other patient died as a result of disease progression with a patent stent.
5.2 A hepatic artery pseudoaneurysm, arising from the central right hepatic artery, occurred in 1 patient who underwent ERCP with radiofrequency ablation catheter treatment in the right hepatic duct, left hepatic duct and the common hepatic duct biliary confluence. It was unclear if the aneurysm was partially or completely within the liver. Treatment with embolisation successfully stopped the haemorrhage and the patient recovered. This adverse event was reported in the Manufacturer and User Facility Device Experience (MAUDE) US Food and Drug Administration (FDA) database.
5.3 Asymptomatic biochemical pancreatitis developed after ERCP in 1 patient in the case series of 22 patients.
5.4 Cholecystitis needing percutaneous gallbladder drainage was reported in 10% (2/21) of patients in the case series of 22 patients. Both patients had tumour encasement of the cystic duct and sepsis before ERCP.
5.5 The Specialist Advisers listed additional anecdotal events as cholangitis and probe breakage inside the patient, and theoretical adverse events as cholangitis, stent occlusion, damage to surrounding tissues, perforation of bile duct, biliary leak, abscess formation and portal vein thrombosis.
Chairman, Interventional Procedures Advisory Committee
This page was last updated: 25 September 2013