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Updated: Feb 22, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Double-blind randomized clinical trial of percutaneous endoscopic gastrostomy versus radiologically inserted
R R Singh1, S A Nah1, D J Roebuck1
1Department of Paediatric Surgery, UCL Great Ormond Street Institute of Child Health and Great Ormond Street Hospital for Children, London, UK.
Insights
Percutaneous endoscopic gastrostomy (PEG) and radiologically inserted gastrostomy (RIG) have similar complication rates in children. This randomized controlled trial found no significant difference in complications between PEG and RIG procedures.
Area of Science:
- Pediatric Gastroenterology
- Interventional Radiology
- Surgical Outcomes
Background:
- Gastrostomy tubes are essential for nutritional support in children.
- Percutaneous endoscopic gastrostomy (PEG) and radiologically inserted gastrostomy (RIG) are common insertion methods.
- Limited comparative data exists on complication rates between PEG and RIG in pediatric populations.
Purpose of the Study:
- To compare the complication rates of PEG versus RIG in pediatric patients.
- To evaluate the safety and efficacy of different gastrostomy insertion techniques.
Main Methods:
- Randomized controlled trial (RCT) involving children requiring primary gastrostomy.
- Patients were randomized to either PEG or RIG insertion.
- Complications were assessed by blinded evaluators and analyzed using zero-inflated Poisson regression.
Main Results:
- 214 children were randomized; 100 received PEG and 96 received RIG.
- No statistically significant difference in the overall number of complications between PEG and RIG groups (P = 0.875).
- Complication scores were similar, with RIG showing a non-significant trend towards higher scores (1.04 times, P = 0.597). Age was a significant factor, with older children having fewer complications.
Conclusions:
- Both PEG and RIG are safe and effective methods for gastrostomy insertion in children.
- The study demonstrated a low rate of major complications for both procedures.
- ClinicalTrials.gov registration: NCT01920438.
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. Registration number: NCT01920438 ( http://www.clinicaltrials.gov).
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