Autologous pancreatic islet cell transplantation for improved glycaemic control after pancreatectomy (interventional procedures consultation)
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional Procedure Consultation Document
Autologous pancreatic islet cell transplantation for improved glycaemic control after pancreatectomy
| The pancreas is an organ at the back of the abdomen that makes insulin. Some conditions such as chronic pancreatitis (long-term inflammation of the pancreas) may require an operation to remove all, or part, of the pancreas. Diabetes develops in these patients as their bodies can no longer make enough insulin. A procedure called autologous pancreatic islet cell transplantation involves the removal of the cells responsible for insulin production, called islet cells, from the pancreas after it has been removed by surgery. These cells are then inserted into the patient?s liver with the aim of restarting insulin production within the body. |
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The National Institute for Health and Clinical Excellence is examining autologous pancreatic islet cell transplantation for improved glycaemic control after pancreatectomy 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 autologous pancreatic islet cell transplantation for improved glycaemic control after pancreatectomy.
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: 25 June 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 | The current evidence on autologous pancreatic islet cell transplantation for improved glycaemic control after pancreatectomy shows some short-term efficacy, although most patients require insulin therapy in the long term. The reported complications result mainly from the major surgery involved in pancreatectomy (rather than from the islet cell transplantation). The procedure may be used with normal arrangements for clinical governance in units with facilities for islet cell isolation (see also section 2.5.1). |
| 1.2 | During consent, clinicians should ensure that patients understand the possibility that they may require insulin therapy in the long term. They should provide them with clear written information. In addition, the use of the Institute's information for patients ('Understanding NICE guidance') is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]] |
| 1.3 | Patient selection for this procedure should involve a multidisciplinary team with experience in the management of benign complex chronic pancreatic disease. The procedure should be carried out by surgeons with experience in complex pancreatic surgery and clinicians with experience in islet cell isolation and transplantation. |
| 1.4 | Further audit and research should address the long-term efficacy of the procedure, quality of life, insulin independence and the management of patients' diabetes (see section 3.1). |
| 2 | The procedure | ||
| 2.1 | Indications and current treatments | ||
| 2.1.1 | Some patients with chronic pancreatitis and with benign pancreatic endocrine tumours are treated by total or partial pancreatectomy, resulting in a type of insulin-dependent diabetes. | ||
| 2.1.2 | Treatment for insulin-dependent diabetes involves the administration of exogenous insulin, usually through daily subcutaneous injections. Post-pancreatectomy diabetes is relatively difficult to control. | ||
| 2.2 | Outline of the procedure | ||
| 2.2.1 | Autologous pancreatic islet cell transplantation is carried out during the same operation as total or partial pancreatectomy. Under general anaesthesia, the pancreatectomy is carried out and the islet cells isolated and prepared for transplantation. Under continuous portal vein pressure monitoring (to help prevent or control potential portal vein thrombosis), the islet cells are infused through a catheter directly into the portal vein or a tributary, and further onto the liver parenchyma, where some will graft. | ||
| 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 | In five case series of 64, 48, 45, 40 and 13 patients treated by autologous islet cell transplantation following partial or total pancreatectomy, between 24% and 85% of patients were insulin independent at follow-up periods ranging from 1 to 18 months (one study did not state follow-up duration). | ||
| 2.3.2 | In the case series of 48 patients, 15 of the 20 patients who were insulin independent at 1 month remained insulin independent at mean follow-up of 5 years, and one patient at 10 years. In the case series of 13 patients, 38% (5/13) were insulin independent at 2-year follow-up. | ||
| 2.3.3 | In the case series of 40 patients, all 14 patients who were followed up at 3 years were classed as either having diabetes or impaired glucose tolerance. In a case series of 24 patients, 33% (8/24) required insulin within 1?8 years after the procedure. | ||
| 2.3.4 | The Specialist Advisers considered key efficacy outcomes to include long-term insulin independence, improved glycaemic control, normal glucose tolerance, avoidance of severe hypoglycaemia, prevention of long-term diabetic complications, and quality of life. | ||
| 2.4 | Safety | ||
| 2.4.1 | The case series of 48 patients reported uncontrollable splenic hilar bleeding due to increased portal pressure in two patients who had concomitant splenectomy. Asymptomatic portal vein thrombosis was suspected in one patient but the vein was not thrombosed one week after the operation. | ||
| 2.4.2 | Two case series of 40 and 24 patients treated sequentially at the same centre reported complications such as pancreatic fistula formation and rupture and subsequent resection of spleen in 16 of the most recent patients in the series in the first (raw data not reported; timing and cause of adverse events not adequately described) and one case each of portal vein thrombosis, splenic infarction and splenic thrombosis requiring splenectomy in the second. | ||
| 2.4.3 | A case report described a patient who developed heparin-induced thrombocytopenia following total pancreatectomy and autologous islet cell transplantation. | ||
| 2.4.4 | The Specialist Advisers considered theoretical and anecdotal adverse events to include portal vein thrombosis, portal hypertension, hepatic infarction, liver steatosis, liver failure, intra-abdominal haemorrhage, bile leakage, splenic rupture, disseminated intravascular coagulation, infection, intrahepatic sepsis and islet cell pulmonary emboli. | ||
| 2.5 | Other comments | ||
| 2.5.1 | The Committee noted that the National Commissioning Group (NCG), which has a remit to commission highly specialised national services for very rare conditions or treatments for the population of England, has designated centres for pancreatic islet cell isolation. Scottish residents also have access to the service under an agreement between the NCG and the National Services Division, Scotland. Health Commission Wales has a separate agreement with the provider for Welsh residents. The Regional Medical Services Consortium (RMSC) commissions specialist regional services for the population of Northern Ireland. The RMSC will commission outside the region, on an individual basis, in cases for which services are not available in Northern Ireland. | ||
| 3 | Further information | ||
| 3.1 | This guidance requires that clinicians undertaking the procedure make special arrangements for audit. The Institute 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 | The Institute has issued a clinical guideline on type 1 diabetes, interventional procedures guidance on allogeneic pancreatic islet cell transplantation for type 1 diabetes mellitus, and technology appraisals guidance on both insulin pump therapy for type 1 diabetes and long-acting insulin analogues for type 1 and 2 diabetes (details can be found at: www.nice.org.uk). | ||
Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
May 2008
| Appendix: | Sources of evidence |
| The evidence considered by the Interventional Procedures Advisory Committee is described in the overview, available at: www.nice.org.uk/ip667overview. | |
This page was last updated: 30 January 2011