Laparoscopic gastrectomy for cancer (interventional procedures consultation)
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional Procedure Consultation Document
Laparoscopic gastrectomy for cancer
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Some patients with gastric cancer can benefit from surgery (gastrectomy), which is usually carried out using open surgery. In this procedure, the gastrectomy is performed using keyhole surgery. A laparoscope and trocars are inserted through small incisions in the abdominal wall. The cancer is then removed in the same way as open surgery. |
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The National Institute for Health and Clinical Excellence is examining laparoscopic gastrectomy for cancer and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. The Institute'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 laparoscopic gastrectomy for cancer.
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.
For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprocessmanual). 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 We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and how it might be improved. Closing date for comments: 24 April 2008 |
| Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation. |
| 1 | Provisional recommendations |
| 1.1 | Current evidence on the safety and efficacy of laparoscopic gastrectomy for cancer appears adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit. |
| 1.2 | This procedure is technically demanding. Surgeons undertaking it should have specific training and special expertise in laparoscopic surgical techniques and should perform their initial procedures with an experienced mentor. |
| 1.3 | Patient selection and management should be carried out in the context of a multidisciplinary team with established experience in the treatment of gastric cancer. |
| 2 | The procedure | ||
| 2.1 | Indications and current treatments | ||
| 2.1.1 | Over 95% of gastric cancers originate from the cells of the stomach lining (adenocarcinoma). This guidance only applies to adenocarcinoma. Certain conditions, such as pernicious anaemia, atrophic gastritis, Helicobacter pylori infection or Barrett's oesophagus may predispose gastric cancer. Symptoms may include heartburn, dysphagia, bloating, loss of appetite and weight loss. Nausea and vomiting may also occur and stools may contain altered blood which may lead to anaemia. | ||
| 2.1.2 | For patients whose gastric cancer is diagnosed at a stage that is amenable to surgical treatment, the options include open or laparoscopic gastrectomy. | ||
| 2.2 | Outline of the procedure | ||
| 2.2.1 | The procedure is usually performed with curative intent. Under general anaesthesia, a laparoscope and trocars are inserted through small incisions in the abdominal wall. A larger incision may also be made so that a hand can be introduced into the peritoneal cavity for hand-assisted laparoscopic gastrectomy or laparoscopically assisted digital gastrectomy (LAPG). Surgery may take the form of total gastrectomy or partial gastrectomy (either proximal or distal), depending on the site of the tumour. Removal of draining lymph nodes is an integral part of the procedure. | ||
| Sections 2.3 and 2.4 describe efficacy and safety outcomes which were available in the published literature and which the Committee considered as part of the evidence about this procedure. For more details, refer to the Sources of evidence. | |||
| 2.3 | Efficacy | ||
| 2.3.1 | A multicentre case series of 1249 patients with early gastric cancer treated with laparoscopic gastrectomy reported 5-year disease-free survival of 99.8% for stage IA disease, 98.7% for stage IB disease, and 85.7% for stage II disease. In a second case series of 100 patients with more advanced disease, 5-year overall and disease-free survival were 59% and 57% respectively, with overall survival ranging from 100% for stage 1A to 9% for stage IV. | ||
| 2.3.2 | In a non-randomised controlled trial of 102 patients, the mortality rate due to cancer recurrence among the 44 patients treated with LADG was 5% (2/44) at mean follow-up of 14 months. In a second non-randomised controlled trial of 52 patients, 4% (1/24) of the 24 patients treated with either partial or total laparoscopic gastrectomy died of metastatic cancer at 1-year follow-up. | ||
| 2.3.3 | In the non-randomised controlled trial of 102 patients, including 44 patients treated with laparoscopic gastrectomy, and two case series of 1294 and 100 patients treated with laparoscopic gastrectomy, conversion from laparoscopic to open surgery was reported in 2% (1/44), 1% (14/1294) and 3% (3/100), respectively. Reasons for conversion included anatomical constraints, bleeding and mechanical problems. | ||
| 2.3.4 | In a meta-analysis of 1611 patients with early gastric cancer, including 837 treated with laparoscopic procedures, significantly fewer lymph nodes were removed by LADG than by open distal gastrectomy (weighted mean difference -4.35 nodes, 95% confidence interval -5.73 to -2.98 nodes, p < 0.0001). | ||
| 2.3.5 | The Specialist Advisers considered key efficacy outcomes to include 30-day mortality, cancer survival rates, adequate surgical margins, operative complication rates, return to theatre and lymph node clearance. | ||
| 2.4 | Safety | ||
| 2.4.1 | The meta-analysis of 1611 patients (837 patients treated with laparoscopic procedures) reported that there were fewer complications overall following LADG (11% [58/535]) than following open gastrectomy (18% [97/519]) (odds ratio [OR] 0.54; p < 0.001). However, there was no significant difference between the groups with respect to rates of mortality, anastomotic leak, anastomotic stricture or wound infection. | ||
| 2.4.2 | A multicentre case series reported perforation (not otherwise described) in <1% (1/1294) of patients. A non-randomised controlled trial of 102 patients (44 undergoing laparoscopic procedures) reported that there were more cases of pulmonary infection following open gastrectomy (10% [6/58]) than following LADG (2% [1/44]) for gastric cancer; however this difference was not statistically significant (p = 0.110). | ||
| 2.4.3 | The reported rate of postoperative bleeding ranged from 1% (14/1294) to 2% (1/44) across the included studies. | ||
| 2.4.4 | In a non-randomised controlled trial of 52 patients, including 24 patients treated with laparoscopic procedures, delayed gastric emptying requiring parenteral nutrition for 16 days occurred in 6% (1/16) of patients treated with laparoscopic partial gastrectomy. | ||
| 2.4.5 | In the meta-analysis, there were significantly fewer cases of ileus following LADG than following open gastrectomy (OR 0.27; p < 0.02). In the multicentre case series, ileus following laparoscopic gastric resection occurred in <1% (3/1294) of patients. | ||
| 2.4.6 | The Specialist Advisers stated that anecdotal adverse events include port insertion injury to intra-abdominal organs or vessels, bleeding, venous thromboembolism, complications of prolonged pneumoperitoneum, anastomotic/duodenal stump leak, chyle leaks, incomplete resection, and anastomotic stricture. They also listed theoretical adverse events including inadequate lymphadenectomy, cancer seeding, Roux limb ischaemia, infection, cardiac complications and port site hernias. | ||
| 2.5 | Other comments | ||
| 2.5.1 | The Committee noted that most of the evidence on this procedure related to practice in parts of Asia where gastric cancer is substantially more common than in the UK; population screening leads to detection of many cancers at an early stage and laparoscopic gastrectomy is frequently used for early stage gastric cancer. | ||
| 2.5.2 | The Committee noted theoretical concerns regarding the number of lymph nodes removed using this procedure and the possible effect on tumour recurrence. However, the evidence on survival showed no difference compared with open surgical resection. Further publication of long-term outcomes would be useful. | ||
| 3 | Further information | ||
| 3.1 | The Institute has produced guidance on colorectal cancer (www.nice.org.uk/CSGCC) and technology appraisals guidance on imatinib for the treatment of unresectable and/or metastatic gastrointestinal stromal tumours (www.nice.org.uk/TA086). | ||
Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
March 2008
| Appendix: | Sources of evidence |
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The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.
Available from: www.nice.org.uk/ip677overview. |
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This page was last updated: 30 March 2010