5 Safety

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 interventional procedure overview.

5.1 Perforation of the duodenal bulb was seen 4 weeks after implantation of a duodenal–jejunal 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.

5.2 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.

5.3 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 non‑compliance with follow‑up in 2 patients (at 20 and 32 weeks); and discovery of an unrelated malignancy in 1 patient (at 17 weeks).

5.4 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).

5.5 Pancreatitis was reported in 2 patients in a case series of 152 patients. Further management details were not reported (conference abstract).

5.6 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 diet‑alone 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.

5.7 Device-related back pain was reported in 23% (5/22) of patients in the case series of 22 patients.

5.8 Mild‑to‑moderate hypoglycaemia was reported in 24% (9/38) of patients in the DJBL plus diet group and 26% (10/39) of patients in the diet‑alone group in the RCT of 77 patients.

5.9 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.

5.10 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; gastro‑oesophageal reflux disease; oesophagitis; duodenitis; pseudopolyps; peptic ulcer disease; and adynamic ileus.

  • National Institute for Health and Care Excellence (NICE)