Interventional procedure consultation document

Implantation of a duodenal–jejunal bypass sleeve for managing obesity

Treating obesity by inserting an artificial sleeve into the bowel

In this procedure a plastic tube-like sleeve or liner is inserted through the mouth into the bowel to line the upper part of the bowel. This is usually removed through the mouth after a year. It forms a barrier between food and the bowel, slows digestion, and reduces absorption of food.

The National Institute for Health and Clinical Excellence (NICE) is examining implantation of a duodenal–jejunal bypass sleeve for the management of obesity and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’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 implantation of a duodenal–jejunal bypass sleeve for the management of obesity.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE 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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

   

  For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).

  Through its guidance NICE is committed to promoting race and disability equality, 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 interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

  In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

  Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations between people with a characteristic protected by the equalities legislation and others?

  Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

  Closing date for comments: 19 April 2013

  Target date for publication of guidance: 13 July 2013

  1                      Provisional recommendations

  1.1                  Current evidence on the safety and efficacy of implantation of a duodenal–jejunal bypass sleeve (DJBS) for managing obesity is limited in quality and quantity. Therefore, this procedure should only be used in the context of research.  

  1.2                  Clinicians should enter details about all patients undergoing implantation of a DJBS for managing obesity onto the National Bariatric Surgery Register and review local clinical outcomes.

  1.3                  Well-controlled studies are needed to support the current limited evidence on weight loss in the short term. They should document patient selection, all complications (while the device is in place and after its removal) and technical problems associated with placing and removing the device.

  2                      Indications and current treatments

  2.1                  Obesity is defined as a body mass index (BMI) of 30 kg/m² or more. It is a risk factor for comorbidities such as type 2 diabetes, coronary heart disease and hypertension. Weight loss reduces the risks of comorbidities and improves long-term survival.

  2.2                  Obesity is managed by dietary advice, exercise, lifestyle changes and medication. Bariatric surgery is considered as a treatment option in selected patients whose BMI is over 40 kg/m², or over 35 kg/m² for patients with other significant comorbidities, if they have not lost enough weight using non‑surgical measures.

  2.3                  Surgical procedures aim to help patients lose weight by restricting the size of the stomach (for example, gastric banding or sleeve gastrectomy) and/or by decreasing the patient’s capacity to absorb food (for example, Roux-en-Y gastric bypass or biliopancreatic diversion).

  3                      The procedure

  3.1                  Endoscopic implantation of a DJBS is a minimally invasive procedure that is designed to promote weight loss in patients with obesity. It has been used before bariatric or other major surgical procedures with the aim of reducing the risk of postoperative complications.

  3.2                  The procedure is done with the patient under general anaesthesia or sedation, using image guidance. The sleeve is positioned endoscopically (via the mouth). Using a delivery catheter, a capsule containing a single-use impermeable DJBS is positioned in the duodenal bulb just distal to the pylorus and is secured there using an integral spring metal anchor. The sleeve is advanced distally into the jejunum with the aid of a tension wire which is integral to the introducer device. It extends approximately 60 cm down the small intestine and forms a barrier between food and the intestinal wall, delaying the mixing of digestive enzymes with the food and reducing absorption.

  3.3                  After the procedure, patients are placed on a diet that typically involves progression from fluids to semi-solid foods, avoiding solid foods for several weeks.

  3.4                  After a maximum of a year, the sleeve is removed at endoscopy under sedation, using image guidance. The anchor incorporates a drawstring mechanism that enables it to be collapsed and partly withdrawn into a plastic hood fitted to the endoscope. The entire device is then withdrawn.

  4                      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 overview.

  4.1                  A randomised controlled trial (RCT) of 56 patients with obesity comparing DJBS (n=27) against sham endoscopy (n=29) reported significantly higher percentage of excess weight loss at 12-week follow-up for the DJBS group (n=13) than for the sham endoscopy group (n=24): 11.9±1.4% and 2.7±2.0% respectively (p=0.001). A case series of 42 patients with obesity treated by DJBS reported 47.0±4.4% (p<0.0001) excess weight loss at 52-week follow-up.

  4.2                  An RCT of 18 patients with obesity and type 2 diabetes comparing DJBS (n=12) against sham endoscopy (n=6) reported that glycated haemoglobin (HbA_1c) values decreased by 1.3±0.9% for the DJBS group and by 0.8±0.3% in the sham endoscopy group (p>0.05) at 12-week follow-up. At 24-week follow-up, the HbA_1c had decreased by 2.4±0.7% in the DJBS group and by 0.8±0.4% in the sham endoscopy group (p>0.05).

  4.3                  The case series of 42 patients with obesity treated by DJBS reported significant reductions from baseline in total cholesterol (from 197±7 mg/dL to 161±8 mg/dL; p<0.0001), triglycerides (from 160±16 mg/dL to 115±11 mg/dL; p=0.002) and blood pressure (systolic from 134±3 mmHg to 125±2 mmHg [p=0.01] and diastolic from 85±1 mmHg to 71±2 mmHg [p<0.0001]) at 52-week follow-up.

  4.4                  Implantation failure was reported in 20% (4/25) of patients because of a short duodenal bulb (n=3) or a combination of patient anatomy and investigator inexperience (n=1) in the RCT of 56 patients.

  4.5                  The case series of 42 patients with obesity reported that, without any kind of maintenance programme, patients who completed 52 weeks of follow-up regained a mean of 4.4 kg 6 months after removal of the DJBS.

  4.6                  A case series of 22 patients with obesity and type 2 diabetes reported that improvement in HbA_1c levels continued for up to 6 months after device removal in 11 patients (mean percentage decrease 1.7±0.7%).

  4.7                  The Specialist Advisers listed an additional key efficacy outcome measure as patient-reported quality of life.

  5                      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 overview.

  5.1                  Gastrointestinal bleeding with haematemesis was reported in 3 patients at 11, 25 and 43 days after the procedure respectively, in the DJBS group of the RCT of 56 patients. The devices were removed. One patient needed sclerotherapy and endoscopic clips and 2 did not need further interventions to stop the bleeding.

  5.2                  Device migration was reported in 41% (5/12) of patients in the DJBS group (4 because of anchor migration and 1 because of ‘device turning or migration’) during 12 weeks of follow-up in the RCT of 18 patients. Three patients presented with symptoms (1 with moderate pain, 1 with nausea, and 1 with vomiting and abdominal pain) and 2 patients had no symptoms, but device migration was noted at removal (n=1) and at follow-up endoscopy (n=1). All devices were removed. 

  5.3                  Sleeve obstruction with severe nausea and vomiting on day 30 was reported in 1 patient in the RCT of 40 patients. Symptoms resolved after removal of the device.

  5.4                  One pharyngeal mucosal tear and 1 oesophageal tear occurred during device removal in a case series of 12 patients. Further intervention was not needed.

  5.5                  Nausea and upper abdominal pain were reported in 77% (20/26) and 50% (13/26) of patients respectively (mainly in the first week after the procedure) in the DJBS group of the RCT of 41 patients. All events resolved with medication. Continuous epigastric pain was reported in 1 patient in the RCT of 41 patients. This resolved after removal of the device at 3 months.

  5.6                  Pseudopolyp formation and implant site inflammation were noted during explantation or at follow-up endoscopy in 50% (13/26) and 38% (10/26) in the DJBS group of the RCT of 41 patients.

  5.7                  The Specialist Advisers listed anecdotal adverse events as multiple linear ulcerated areas with perforation in the proximal jejunum, erosion of the duodenal wall, device malplacement, misplacement of the endoscope hood in the pharynx during endoscopic removal of the device, and inability to remove an obstructed and migrated device endoscopically (needing a laparotomy for removal). The Specialist Advisers listed theoretical adverse events as implantation failure; perforation of the oesophagus, stomach, duodenum or proximal jejunum and consequent laparotomy; and reduced absorption of dietary calcium and iron.

  6                      Committee comments

  6.1                  The Committee considered that the quality of RCTs was poor, with substantial loss of patients to follow-up and potential for bias.

  6.2                  The Committee noted that patients with obesity who had this procedure experienced improvement in comorbidities including diabetic control, hypertension and lipid profile.

  Bruce Campbell

  Chairman, Interventional Procedures Advisory Committee

  March 2013