The National Institute for Clinical Excellence is examining laparo-endogastric surgery 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 laparo-endogastric surgery. 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 Procedures 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: 22 July 2003

Target date for publication of guidance: 24 December 2003

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 laparo-endogastric surgery does not appear adequate to support the use of this procedure without special arrangements for consent and for audit or research. Clinicians wishing to undertake laparo-endogastric surgery 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 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.

The Advisory Committee noted that the technique is likely to have limited application in the foreseeable future.

Laparo-endogastric surgery is used to treat lesions located in the fundus of the stomach, the gastroesophageal junction, and near the pylorus. They include gastric polyps, gastric wall tumours (lymphomas, leiomyomas leiomyosarcomas, carcinoids), gastric cancer, Dieulafoy's lesion (arterial malformation) and intractable gastroduodenal ulcers. Lesions on the greater and lesser curvatures are relatively inaccessible.

Large or advanced gastric cancers are rarely suitable for laparo-endogastric surgery.

Traditional approaches to gastric surgery are resection operations through a laparotomy incision or laparoscopy.

Laparo-endogastric surgery is a minimally invasive approach to surgery for gastric wall lesions, and attempts to avoid resection of the full thickness of stomach wall. With the patient under general anaesthetic, the surgeon passes an endoscope through the oesophagus into the stomach. A laparoscope is inserted through a small incision in the upper abdominal wall, passed into the stomach, and surgery is performed from inside the stomach.

Evidence was from small, uncontrolled case series. The efficacy of the procedure compared with conventional open laparotomy or laparoscopic partial gastrectomy remains uncertain.

Specialist Advisors considered laparo-endogastric surgery to be a very new procedure carried out in very few specialist units worldwide. The technique is not widely disseminated, and there are few opportunities for training. One Specialist Advisor questioned the procedure's efficiency in excising small malignant lesions completely.

Few complications were reported in the studies. As the case series are so small, it is not possible reliably to estimate the frequency of complications.

Specialist Advisors noted that possible complications include leaking at the site of repair to the stomach following surgery and subsequent infection or bleeding but these were uncommon.

The Advisory Committee noted that the inadequate visualisation of tumours might lead to staging errors, and identified tumour spillage as a potential risk.

The following source of evidence was considered by the Interventional Procedures Advisory Committee.

• Interventional Procedure Overview of Laparo-endogastric Surgery, November 2002