5 Safety

Guidance

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 Overall mortality after endoscopic necrosectomy was reported as 5% (range 0 to 25% per study) in a systematic review of 938 patients. Death was reported in 10% (1/10) of patients treated by endoscopic necrosectomy and 40% (4/10) of patients treated by surgical necrosectomy (p=0.30) in a randomised controlled trial of 20 patients (included in the systematic review). The death rate was 0% (0/11) in patients treated by endoscopic necrosectomy compared with 14% (3/21) in patients treated by surgical necrosectomy (p=0.53) in a non-randomised comparative study of 32 patients (included in the systematic review). In-hospital mortality was 0% (0/12) for patients treated by endoscopic necrosectomy compared with 8% (1/12) for patients treated by a step-up approach in a non-randomised comparative study of 24 patients (included in the systematic review).

5.2 Fatal gas embolism after endoscopic transgastric necrosectomy with carbon dioxide insufflation was described in a case report. Air embolism was reported in less than 1% (4/938) of patients in the systematic review of 938 patients.

5.3 Bleeding was reported in 11% (103/938) of patients in the systematic review of 938 patients. Bleeding was reported in 8% (1/12) of patients treated by endoscopic necrosectomy and 50% (6/12) of patients treated by surgical necrosectomy in the non-randomised comparative study of 24 patients (included in the systematic review).

5.4 Pancreatic fistula was reported in 5% (9/187) of patients in a systematic review of 455 patients. It was also reported in 10% (1/10) of patients treated by endoscopic necrosectomy and 70% (7/10) of patients treated by surgical necrosectomy (p=0.02) in the randomised controlled trial of 20 patients (included in the systematic review). Pancreatic fistula was reported in 0% (0/11) in patients treated by endoscopic necrosectomy compared with 38% (8/21) of patients treated by surgical necrosectomy (p=0.03) in a non-randomised comparative study of 32 patients.

5.5 Spontaneous perforation of a hollow organ (apart from the stomach or duodenum because of the intervention) was reported in 4% (9/249) of patients in the systematic review of 455 patients. Bowel perforation was reported in 1 patient treated by endoscopic necrosectomy in the non-randomised comparative study of 32 patients. Perforation was reported in 5% (3/57) of patients in the case series of 57 patients.

5.6 New-onset organ failure was reported in 18% (2/11) of patients treated by endoscopic necrosectomy and 17% (5/21) of patients treated by surgical necrosectomy (p=0.99) in the non-randomised comparative study of 32 patients.

5.7 Stent complication (not further described) was reported in 9% (2/11) of patients treated by endoscopic necrosectomy in the non-randomised comparative study of 32 patients.

5.8 Pneumoperitoneum, without the need for intervention or treated by needle aspiration, was reported in 5% (4/81) of patients in the case series of 81 patients.

5.9 New-onset diabetes (assessed 6 months after hospital discharge) was reported in 22% (2/9) of patients treated by endoscopic necrosectomy and 50% (3/6) of patients treated by surgical necrosectomy (p=0.33) in the randomised controlled trial of 20 patients.

5.10 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers listed the following anecdotal adverse events: slipping of irrigation tube, stent migration, prolonged hospital stay, and sedation-related adverse reactions. They considered that the following were theoretical adverse events: splenic vein thrombosis with portal hypertension and oesophageal varices, introduction or exacerbation of infection, and fluid overload.