Interventional procedure consultation document

Percutaneous pancreatic necrosectomy

Keyhole removal of dead tissue to treat pancreatic necrosis

The pancreas produces juices that contain substances (enzymes) that help to digest food. Sometimes these substances can attack the pancreas itself. This can happen 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). Some patients with acute pancreatitis develop a complication called necrosis, when part of the pancreas is destroyed. This is a serious condition with high risk of death, and removal of the dead tissue is required as part of the management.

The usual way of removing the destroyed part of the pancreas is by open surgery. Percutaneous pancreatic necrosectomy is an alternative treatment option where a thin telescope, inserted through a small cut in the side above the hip, is used to wash out and remove the dead tissue.

The National Institute for Health and Clinical Excellence (NICE) is examining percutaneous 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 percutaneous 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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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).

NICE is committed to promoting through its guidance race and disability equality and 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 guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. 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 December 2010

Target date for publication of guidance: March 2011

1   Provisional recommendations

1.1  Current evidence on the safety and efficacy of percutaneous pancreatic necrosectomy is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit.

1.2  The procedure 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 can occur in some patients (with or without the formation of a pseudocyst). It is a condition associated with significant morbidity, requiring prolonged hospitalisation, and it has a high mortality.

2.1.2  Current treatment options for pancreatic necrosis include conventional open or laparoscopic necrosectomy.

2.2   Outline of the procedure

2.2.1  Percutaneous pancreatic necrosectomy aims to remove necrotic tissue under direct vision. Percutaneous drainage may be attempted as part of the management prior to the procedure. 

2.2.2  With the patient under general anaesthesia, an endoscope (which may be rigid or flexible) is inserted via a postero-lateral approach into the retroperitoneal space to visualise the area of necrosis. Dead tissue is removed using suction and debrided where necessary using forceps. Drains may be placed for irrigation in the post-operative period. The procedure may be repeated if required.

Sections 2.3 and 2.4 describe efficacy and 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, available at www.nice.org.uk/guidance/IP/103a/overview

2.3   Efficacy

2.3.1  A randomised controlled trial (RCT) of 88 patients treated by a step-up protocol using percutaneous pancreatic necrosectomy after failure of percutaneous drainage, or by primary open necrosectomy, reported mortality rates of 19% (8/43) and 16% (7/45) respectively (p = 0.70) (6-month follow-up). In the step-up group  60% (26/43) of patients underwent percutaneous pancreatic necrosectomy, 35% (15/43) of patients required drainage alone and 5% (2/43) of patients with multiple organ failure were too unstable for percutaneous pancreatic necrosectomy surgery and underwent endoscopic transgastric drainage.

2.3.2  A non-randomised controlled study of 189 patients treated by percutaneous or open pancreatic necrosectomy reported mortality rates of 19% (26/137) and 38% (20/52) respectively (p = 0.009) (follow-up not stated).

2.3.3  A non-randomised controlled study of 30 patients treated by percutaneous or open necrosectomy reported in-hospital mortality rates of 7% (1/15) and 40% (6/15) respectively (p = 0.08).

2.3.4  The non-randomised controlled study of 30 patients treated by percutaneous or open necrosectomy reported postoperative multiple organ failure in 13% (2/15) and 67% (10/15) of patients respectively (p = 0.008).

2.3.5  The RCT of 88 patients treated by a step-up protocol using percutaneous pancreatic necrosectomy after failure of percutaneous drainage, or by open necrosectomy, reported rates of major complication or death of 40% (17/43) and 69% (31/45) respectively (p = 0.006) (follow-up not stated).

2.3.6  The Specialist Advisers listed key efficacy outcomes as a reduction in mortality and morbidity, reduction of requirement for post-operative critical care, number of interventions required and length of hospital stay.

2.4   Safety

2.4.1  The RCT of 88 patients treated by a step-up protocol using percutaneous pancreatic necrosectomy after failure of percutaneous drainage, or by open necrosectomy, reported fistula formation or perforation requiring intervention in 33% (14/43) and 22% (10/45) of patients respectively (p = 0.32) (follow-up not stated).

2.4.2  Bowel perforation occurred in 7% (1/15) of patients treated by percutaneous necrosectomy and in 13% (2/15) of patients treated by open necrosectomy in the non-randomised controlled trial of 30 patients (p = not significant). In the same study, pancreatic fistula developed in 13% (2/15) of patients and 0% (0/15) of patients respectively (p = not significant).

2.4.3  The RCT of 88 patients reported that bleeding requiring intervention occurred in 16% (7/43) of patients treated in the step-up group and in 22% (10/45) of patients treated by open necrosectomy (p = 0.48).

2.4.4  The Specialist Advisers stated that adverse events reported in the literature include incomplete drainage and/or sepsis control, iatrogenic injury to the kidney or spleen, colonic necrosis, pseudocyst formation, venous thrombosis and death.

3   Further information

3.1  This guidance is a review of ‘Percutaneous pancreatic necrosectomy’ NICE interventional procedures guidance 33 (2003).

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

November 2010

_{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.}