Endoscopic transluminal drainage of pancreatic pseudocyst and pancreatic necrosectomy - Consultation Document

Interventional procedure consultation document

Endoscopic transluminal drainage of pancreatic pseudocyst and pancreatic necrosectomy

Removing dead tissue from the pancreas using an endoscope through the mouth.

The pancreas produces juices that help to digest food. However, these digestive juices can attack the pancreas itself, for example if the tube that normally takes the juices to the gut becomes blocked. This can cause swelling of the pancreas and severe pain in the abdomen (acute pancreatitis). A serious complication of acute pancreatitis is pancreatic necrosis, which typically requires removal of the dead tissue, either by needle or open surgery.

This procedure (transluminal endoscopic pancreatic necrosectomy) is an alternative treatment option. A thin telescope (called an endoscope) is inserted through the mouth. Special instruments are then passed through the stomach wall in order to wash out and remove the dead tissue.

The National Institute for Health and Clinical Excellence (NICE) is examining endoscopic transluminal drainage of pancreatic pseudocyst and pancreatic necrosectomy 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 transluminal drainage of pancreatic pseudocyst and pancreatic necrosectomy.

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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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 and promote equality 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: 24 June

Target date for publication of guidance: September 2011

1   Provisional recommendations

1.1  Current evidence on the efficacy and safety of endoscopic transluminal drainage of pancreatic pseudocyst (simple placement of a drain without instrumentation) is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit.

1.2  Endoscopic transluminal aspiration, with or without removal using instruments of pancreatic necrosis (necrosectomy), involving passage of an endoscope through the gastric wall, shows the potential for serious complications. Evidence on small numbers of patients shows that endoscopic transluminal necrosectomy is efficacious, but repeated procedures are often required. This procedure should only be used with special arrangements for clinical governance, consent and audit or research.

1.3  Clinicians wishing to undertake endoscopic transluminal aspiration, with or without removal using instruments, of pancreatic necrosis (necrosectomy) by passage of an endoscope through the gastric wall 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. In addition, the use of NICE’s information for patients (‘Understanding NICE guidance’) is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]
• Audit and review clinical outcomes of all patients having endoscopic transluminal aspiration of pancreatic necrosis (see section 3.1).

1.4  Endoscopic transluminal drainage of pancreatic pseudocyst and pancreatic necrosectomy should only be carried out by a team experienced in the management of complex pancreatic disease.

2   The procedure

2.1   Indications and current treatments

2.1.1  Pancreatic necrosis (also called necrotising pancreatitis) is a serious complication of acute pancreatitis that occurs in some patients. It is often accompanied by the formation of a pseudocyst. It is associated with significant morbidity, requiring prolonged hospitalisation, and high mortality.

2.1.2  Traditionally pancreatic necrosis has been treated by open necrosectomy via laparotomy, but image-guided drainage or laparoscopic drainage may also be used.

2.2   Outline of the procedure

2.2.1  Endoscopic transluminal drainage of pancreatic pseudocyst and pancreatic necrosectomy aim to remove necrotic material without the need for, and associated morbidity of, open surgical necrosectomy.

2.2.2  Endoscopic transluminal drainage of pancreatic pseudocyst and pancreatic necrosectomy is performed with the patient under conscious sedation and using upper gastrointestinal endoscopy and endosonographic guidance. Drainage involves creating an opening by diathermy in the posterior wall of the stomach or duodenum: this allows the contents of a pseudocyst to drain into the gastrointestinal tract. One or more stents or irrigation catheters may be left in situ to facilitate further drainage into the stomach.   Drainage can be performed alone, or in combination with necrosectomy.  For necrosectomy, balloon dilatation may be done of the opening in the stomach (or duodenum) to enable passage of endoscopic instruments. CO2 insufflation is usually used to aid visualisation of the retroperitoneal space. Any retroperitoneal fluid collection is drained and dead tissue is then removed using suction, forceps, and irrigation. Repeated sessions may be needed, a few days apart.

2.3   Efficacy

2.3.1  A non-randomised controlled study of 45 patients treated by endoscopic transluminal necrosectomy or standard drainage alone reported 90% resolution of the cavity without further surgical or percutaneous intervention in 88% and 45% of patients respectively at 4-month follow-up (p = 0.003).

2.3.2  A case series of 93 patients treated by endoscopic transluminal necrosectomy reported short-term (up to 30 days) and long-term freedom from symptoms with no further intervention in 81% (75/93) and 68% (63/93) of patients respectively (mean follow-up 43 months).

2.3.3  In the non-randomised controlled study of 45 patients treated by endoscopic transluminal necrosectomy or standard drainage alone, recurrent collections were reported in 8% and 40% of patients respectively at follow-up longer than 6 months (p = 0.014).

2.3.4  A case series of 53 patients treated by endoscopic transluminal necrosectomy reported complete or almost complete resolution of collection and no clinical symptoms in 81% (43/53) of patients at 6-month follow-up. However, 40% (21/53) of patients were also treated by concurrent percutaneous drainage at the time of the initial procedure.

2.3.5  In a non-randomised study of 83 patients comparing endoscopic transluminal versus laparoscopic versus open surgical drainage of pancreatic pseudocysts (45, 16 and 22 patients respectively), 64% (29/45) of patients treated by endoscopic transluminal drainage were managed successfully without the need for subsequent laparoscopic or open drainage.

2.3.6  The Specialist Advisers listed key efficacy outcomes as resolution of pain and inflammation, reduction of cyst size, length of stay, number of procedures required, and recurrence rate.

2.4   Safety

2.4.1  Bleeding was reported in 32% of patients treated by endoscopic transluminal necrosectomy and 20% of patients treated by standard drainage alone in the non-randomised controlled study of 45 patients (p = 0.50) (follow-up not stated). Bleeding occurred in a total of 15% (22/146) of patients in  case series of 93 patients and 53 patients considered together. In the case series of 93 patients, 1 patient died as a consequence of bleeding and 2 required surgery. In the case series of 53 patients, 2 required repeat endoscopy and 2 required intensive care and blood transfusion.

2.4.2  Air embolism was reported in 2% (2/93) of patients in the case series of 93 patients (1 patient died and 1 had a non-fatal cerebral infarction).

2.4.3  Perforation of necrosis in the abdominal cavity occured in 2% (2/93) of patients in the case series of 93 patients (1 patient died and 2 required surgery).

2.4.4  Gallbladder puncture occurred in 1 patient in the case series of 53 patients. Bile duct stenting was required.

2.4.5  The Specialist Advisers listed anecdotal adverse events as leak of cyst contents and technical failure. The Specialist Advisers considered theoretical adverse events as infection and death.

3   Further information

3.1  This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion), which will be available when the guidance is published.

3.2  For related NICE guidance see www.nice.org.uk

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

May 2011

_{Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.}

 _{It is the responsibility of consultees to accurately cite academic work in order that they can be validated.}