Implantation of a duodenaljejunal bypass liner for managing type 2 diabetes

# Recommendations
Current evidence on the safety and efficacy of implantation of a duodenaljejunal bypass liner for managing type 2 diabetes is limited in quality and quantity. Therefore the procedure should only be used in the context of research.
Further research should give details of patient selection, including information about use of the procedure in patients with different levels of BMI. The research should provide information on complications; reasons for early removal of the device; medication used for treating type 2 diabetes, both when the device is in place and after its removal; and control of type 2 diabetes after device removal. NICE may update the guidance on publication of further evidence.# Indications and current treatments
Type 2 diabetes is caused by insulin resistance with or without inadequate pancreatic insulin secretion. It is most commonly seen in people with obesity or who are overweight. Presenting symptoms include polyuria, polydipsia and fatigue. Type 2 diabetes is commonly associated with raised blood pressure, abnormal blood lipid levels and a tendency to atherosclerosis. This combination is often described as the 'metabolic syndrome', which is associated with fatty liver and abdominal adiposity (increased waist circumference).
Type 2 diabetes is managed by lifestyle and dietary changes, exercise and oral antidiabetic drugs (as recommended in NICE's guideline on type 2 diabetes). If blood glucose levels remain poorly controlled, subcutaneous insulin injections may be needed.# The procedure
Endoscopic implantation of a duodenaljejunal bypass liner (DJBL) is a procedure that aims to improve glycaemic control in people with obesity or who are overweight.
The procedure is done with the patient under general anaesthesia or sedation, using image guidance. The liner is positioned endoscopically (via the mouth). Using a delivery catheter, a capsule containing a singleuse impermeable DJBL is positioned in the duodenal bulb just distal to the pylorus. It is secured there using an integral spring metal anchor. The liner is advanced distally into the jejunum using a tension wire that is part of the 'introducer' device. It extends about 60 cm down the small intestine and forms a barrier between food and the intestinal wall, delaying the mixing of digestive enzymes with food.
After the procedure, patients are recommended a diet that typically involves progression from fluids to semisolid foods and then to solid foods.
After a maximum of a year, the liner is removed with the patient under sedation, using image guidance and endoscopy. The anchor has a drawstring mechanism such that it can be collapsed and partly withdrawn into a plastic hood fitted to the endoscope before withdrawal.# Efficacy
This section describes efficacy 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 interventional procedure overview.
A randomised controlled trial (RCT) of 77 patients with obesity and type 2 diabetes compared duodenaljejunal bypass liner (DJBL) treatment in combination with dietary intervention (n=38) against dietary intervention alone (n=39) for 6 months. It reported that glycated haemoglobin (HbA1c) levels improved from 8% at baseline to 7% in the DJBL plus diet group, but remained at about 8% in the dietalone group at 6month followup. The difference between the 2 groups was significant (p<0.05).
The RCT of 77 patients reported that, at 12month followup (including 6 months after DJBL removal), fasting glucose levels had decreased from 11.0 mmol/litre to 9.0 mmol/litre in the DJBL plus diet group compared with 9.7 mmol/litre in the dietalone group. The difference between the 2 groups was not significant (p=0.41).
The RCT of 77 patients reported that, at 12month followup (including 6 months after DJBL removal), fasting insulin levels remained the same in the DJBL plus diet group (15.0 mU/litre), and decreased in the dietalone group (from 17.0 mU/litre to 15.7 mU/litre). The difference between the 2 groups was not significant (p=0.73).
A case series of 22 patients with obesity and type 2 diabetes treated with a DJBL reported that improved glycaemic control (mean percentage decrease of 1.70.7% in HbA1c from a baseline level of 8.91.7%) continued for up to 6 months after device removal in 11 patients.
The RCT of 77 patients reported that, at 12month followup, blood pressure had decreased from 147/92 mmHg to 130/82 mmHg in the DJBL plus diet group and from 152/90 mmHg to 140/85 mmHg in the dietalone group. The difference between the 2 groups was not significant (p=0.31 for systolic pressure and p=0.38 for diastolic pressure). At 12month followup, total cholesterol levels were comparable with those at baseline and the difference between the 2 groups was not significant (4.4 mmol/litre in both groups; p=0.79).
The case series of 22 patients reported significant reductions in total cholesterol (mean decrease of 19.75.9 mg/dl from a baseline level of 20137 mg/dl; p<0.01) and triglycerides (mean decrease of 44.817.4 mg/dl from a baseline level of 21389 mg/dl; p<0.05) at last observation on or before device removal.
A case series of 81 patients reported improvement in insulin resistance, with a significant reduction in triglyceride/high density lipoprotein (HDL) ratio from 5.75 to 4.36 (p<0.001). Also, 43% of patients had a triglyceride/HDL ratio lower than 3.5, 6 months after DJBL implantation.
In the RCT of 77 patients, at 12month followup, the daily insulin dose and use of sulfonylureas had decreased or the medication had been stopped in the DJBL plus diet group more often than in the dietalone group (p<0.05).
In the case series of 81 patients, the DJBL could not be implanted in 4% (3/81) of patients because they had a short duodenal bulb.
The specialist advisers listed key efficacy outcomes as reduced insulin resistance leading to improved glycaemic control; reduction in HbA1c, hypoglycaemic medication use, fasting insulin, Cpeptide and HOMAIR; and improvement in hypertension and quality of life, both in the short and long term (that is, after the device has been removed).# Safety
This section describes 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 interventional procedure overview.
Perforation of the duodenal bulb was seen 4 weeks after implantation of a duodenaljejunal bypass liner (DJBL) in a case report of 1 patient. The device was removed endoscopically and the perforation was closed laparoscopically with a running suture. The patient was discharged 9 days after the surgery.
Oesophageal perforation during device removal at 6 months (caused by one of the barbs on the anchor not being covered by the removal hood) was reported in 1 patient in the DJBL plus diet group (n=38) in a randomised controlled trial (RCT) of 77 patients with obesity and type 2 diabetes. This was treated by endoscopic stenting and placement of a feeding tube. The tear had resolved without sequelae by 3 weeks.
Early removal of the device was needed in 40% (9/22) of patients in a case series of 22 patients. This was because of: device migration or rotation in 3 patients (within 48 weeks after implantation); gastrointestinal bleeding in 1 patient (at 4 weeks); abdominal pain in 2 patients (at 24 and 30 weeks); principal investigator request because of noncompliance with followup in 2 patients (at 20 and 32 weeks); and discovery of an unrelated malignancy in 1 patient (at 17 weeks).
In a case series of 79 patients (21 with type 2 diabetes), 26% (21/79) of devices were removed early because of: device migration (n=8); device obstruction (n=5); abdominal pain (n=2); liver abscess (n=1); upper gastrointestinal bleeding (n=1); cholangitis (n=1); ulcerative colitis (n=1); acute cholecystitis (n=1); or patient request (n=1).
Pancreatitis was reported in 2 patients in a case series of 152 patients. Further management details were not reported (conference abstract).
Upper abdominal pain, minor gastrointestinal symptoms or discomfort were reported in 63% (25/38) of patients in the DJBL plus diet group and 28% (11/39) of patients in the dietalone group in the RCT of 77 patients. Nausea and vomiting occurred in 24% (9/38) of patients in the DJBL plus diet group and in 18% (7/39) in the diet alone group, all of whom were managed conservatively.
Device-related back pain was reported in 23% (5/22) of patients in the case series of 22 patients.
Mildtomoderate hypoglycaemia was reported in 24% (9/38) of patients in the DJBL plus diet group and 26% (10/39) of patients in the dietalone group in the RCT of 77 patients.
Metabolic and nutritional disorders, including hypoglycaemia and iron deficiency, occurred in 61% (14/23) of patients in a case series of 23 patients. Further details were not reported.
The specialist advisers listed anecdotal adverse events as difficulties in deploying the device; halting the procedure after endoscopy because of residual food in the stomach; cramping; intussusception; pharyngeal obstruction during device removal; and misplacement of the device hood in the pharynx during device removal. The specialist advisers listed theoretical adverse events as peritonitis; aspiration; infection; dehydration; constipation; belching; bloating; diarrhoea; gastrooesophageal reflux disease; oesophagitis; duodenitis; pseudopolyps; peptic ulcer disease; and adynamic ileus.# Further information
For related NICE guidance, see the NICE website.

# Information for patients
NICE has produced information on this procedure for patients and carers (information for the public). It explains the nature of the procedure and the guidance issued by NICE, and has been written with patient consent in mind.# About this guidance
NICE interventional procedures guidance makes recommendations on the safety and efficacy of the procedure. It does not cover whether or not the NHS should fund a procedure. Funding decisions are taken by local NHS bodies after considering the clinical effectiveness of the procedure and whether it represents value for money for the NHS.
This guidance was developed using the NICE interventional procedures guidance process.
We have produced a summary of this guidance for patients and carers. Information about the evidence the guidance is based on is also available.
NICE produces guidance, standards and information on commissioning and providing highquality healthcare, social care, and public health services. We have agreements to provide certain NICE services to Wales, Scotland and Northern Ireland. Decisions on how NICE guidance and other products apply in those countries are made by ministers in the Welsh government, Scottish government, and Northern Ireland Executive. NICE guidance or other products may include references to organisations or people responsible for commissioning or providing care that may be relevant only to England.
Your responsibility
This guidance represents the views of NICE and was arrived at after careful consideration of the available evidence. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of healthcare professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties.
Copyright
 National Institute for Health and Care Excellence 2015. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
ISBN: 978-1-4731-1126-4