The National Institute for Clinical Excellence is examining the Sugarbaker technique for pseudomyxoma peritonei and will publish guidance on its safety and efficacy to the NHS in England and Wales. 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 the Sugarbaker technique for pseudomyxoma peritonei.

This document has been prepared for public consultation. It summarises the procedure and sets out the provisional recommendation made by the Advisory Committee.

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 the Final Interventional Procedure Document (FIPD) and submit it to the Institute.
• The FIPD may be used as the basis for the Institute's guidance on the use of the procedure in the NHS in England and Wales.

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

Closing date for comments: 23 December 2003

Target date for publication of guidance: March 2004

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 the Sugarbaker technique for pseudomyxoma peritonei does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research. Clinicians wishing to undertake the Sugarbaker technique for pseudomyxoma peritonei should inform the clinical governance leads in their Trusts. They should ensure that patients offered it understand the uncertainty about the procedure's safety and efficacy and should provide them with clear written information. Use of the Institute's Information for the Public is recommended. Clinicians should ensure that appropriate arrangements are in place for audit or research. Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. NICE is not undertaking further investigation at present.

Pseudomyxoma peritonei is a rare, borderline malignant, slowly progressing tumour. It arises from the appendix or bowel and spreads throughout the peritoneal cavity, producing a large amount of mucus. Most patients will develop symptoms due to the bulk of the tumour. Most patients will eventually die of this condition, but they often survive for several years.

Standard treatment for this condition is surgical debulking, in which the surgeon attempts to remove as much tumour as possible. Recurrence is common, and therefore repeated debulking operations may be needed.

Patients with pseudomyxoma peritonei may be treated using a 'watch and wait' policy, using surgery only when unacceptable symptoms or life-threatening complications, such as intestinal obstruction, arise.

The Sugarbaker technique combines complete surgical tumour removal (complete cytoreduction) with intraoperative heated chemotherapy, and is followed by postoperative intraperitoneal chemotherapy The operation takes around 10 hours and includes:

• removal of the right hemicolon, spleen, gallbladder, greater omentum and lesser omentum
• stripping of the peritoneum from the pelvis and diaphragm
• stripping of the tumour from the surface of the liver
• removal of the uterus and ovaries in women
• removal of the rectum in some cases

No controlled studies were found. The studies were of poor quality. One of the studies including 385 patients found 5-year survival to be 86% for those with less malignant pathology (adenomucinosis) and 50% for those with more malignant pathology (mucinous adenocarcinoma). However, not all patients in this study were followed up for 5 years, and it is not clear how survival was calculated. Another study found overall 5-year survival to be around 74% in the 98 out of 321 patients who underwent repeat cytoreductive surgery. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors commented that there is international controversy about the effectiveness of the procedure, given the slow natural history of pseudomyxoma peritonei. One Advisor noted that uncertainty about efficacy emanates from the difficulty in accurately diagnosing pseudomyxoma peritonei preoperatively.

In a study of 42 patients the main safety concerns included: prolonged gastric paresis (almost all patients); neutropenia (52%); re-operation for postoperative complications (26%); enteral fistula (14%); stomach or bowel perforation (24%); and peripheral pressure neuropathy (12%). The studies, however, were of poor quality. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors considered there to be the risk of several operative and postoperative complications, such as: death; major blood loss; respiratory infection; peritonitis; bowel perforation; obstruction; adhesions; wound dehiscence; and wound infection. One Advisor commented that such prolonged surgery increased risk of morbidity and mortality.

The Advisory Committee noted that the procedure has a considerable risk of serious side effects, and that efficacy is not clearly established.

The Committee also considered that the procedure needs to be evaluated in comparison with less radical surgery.

The National Specialist Commissioning Advisory Group (NSCAG) has commissioned a service for pseudomyxoma peritonei including the Sugarbaker protocol from the North Hampshire Hospital, Basingstoke and the Christie Hospital, Manchester.

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

• Interventional Procedure Overview of Sugarbaker technique for pseudomyxoma peritonei, October 2002

Available from: www.nice.org.uk/ip079overview