Endoscopic gastrostomy replacement tubes: Long-term randomized trial with five silicone commercial models

Trial design: No analysis of the long-term performance of percutaneous endoscopic gastrostomy (PEG) replacement tubes was identified. A randomized partially blinded trial was designed hypothesizing that clinically relevant limitations of the tubes would be identified. Methods: Patients (N = 100, age 58.3 +/- 20.7 years, 42.0% males, time with PEG 27.0 +/- 22.5 months) were randomized in five parallel intervention groups, each with a tested device (Silmag (R), Bard (R), Freka (R), Kangaroo (R) and Wilson Cook (R)). Eligibility criteria included age 18-90 years, males and females, on home enteral nutrition, and the setting was a large academic hospital. Patients were allocated according to a random numbers list, and independent professionals were responsible for data collection. Primary outcome was tube longevity, calculated by Kaplan-Meier curves and Cox regression analysis. A sample of 18 was calculated based on a 10% effect size and 80% power. Results: Twenty patients were randomized in each group and all were analyzed. There was no morbidity and mortality, however tube dysfunction was common with all models. Fastener sliding occurred in 57.0% and balloon rupture in 32.0%, along with other mishaps. Best tube longevity corresponded to the Wilson Cook model (158.0 +/- 10.0 days, P < 0.05), mostly on account of diminished balloon ruptures. Conclusions: PEG replacement was safe however relatively frequent and affecting longevity, therefore longer-lasting tubes are needed. Specific attention should be given to cap, feeding line, external clamp, tube fastener; tube length, and notably balloon performance, which may be disappointing. (C) 2013 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.