Double-blind randomized clinical trial of percutaneous endoscopic gastrostomy versus radiologically inserted gastrostomy in children.

Background: The aim of this RCT was to determine whether radiologically inserted gastrostomy (RIG) in children is associated with more complications than percutaneous endoscopic gastrostomy (PEG). Methods: Children at a single tertiary children's hospital requiring a primary gastrostomy were randomized to PEG or RIG. Patients were followed by assessors blinded to the insertion method. Complications were recorded, assigned a severity score, and analysed by zero-inflated Poisson regression analysis on an intention-to-treat basis, adjusting for length of follow-up. Results: Over a 3-year period, 214 children were randomized (PEG, 107; RIG, 107), of whom 100 received PEG and 96 RIG. There was no significant difference in the number of complications between PEG and RIG groups (P=0.875), or in the complication score: patients undergoing RIG had a 1.04 (95 per cent c.i. 0.89 to 1.21) times higher complication score than those who underwent PEG (P=0.597). Only age had an independent significant effect on complication score, with older patients having a 0.97 (0.95 to 1.00) times lower complication score per year. Conclusion: PEG and RIG are both safe methods of gastrostomy insertion with a low rate of major complications.