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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
A randomized trial comparing percutaneous endoscopic gastrostomy (PEG) and radiologically inserted percutaneous
Magnus Sundbom1, Eladio Cabrera2, Rickard Nyman2
1Department of Surgical Sciences Uppsala University SE-751 85 Uppsala Sweden.
Insights
Percutaneous endoscopic gastrostomy (PEG) is recommended over radiologically inserted gastrostomy (RIG) for feeding tubes due to fewer complications and lower mortality. Both methods are effective, but PEG offers a safer option for patients with severe dysphagia.
Area of Science:
- Gastroenterology
- Interventional Endoscopy
- Surgical Procedures
Background:
- Percutaneous endoscopic gastrostomy (PEG) is the standard for permanent feeding tubes in chronic severe dysphagia.
- This study is the first prospective randomized comparison of PEG and radiologically inserted gastrostomy (RIG) in adults.
Purpose of the Study:
- To compare the safety and efficacy of PEG versus RIG in adult patients requiring a feeding gastrostomy.
- To evaluate operative time, adverse events, mortality, and health status.
Main Methods:
- 106 adult patients eligible for both PEG and RIG were randomized.
- Data collected included operative time, adverse events at 10 and 30 days, 6-month mortality, and European Quality of Life 5 Dimensions (EQ-5D) scores.
Main Results:
- PEG had a significantly shorter median operative time (10 min vs. 20 min).
- PEG demonstrated a lower rate of adverse events (22% vs. 51%) and 30-day mortality (2% vs. 14%).
- Patient-reported health status remained low but showed improvement in the RIG group.
Conclusions:
- PEG is recommended as the primary procedure for feeding gastrostomy due to fewer tube complications.
- RIG is a valid alternative, and both techniques can complement each other.
Background And Objective:
At present, percutaneous endoscopic gastrostomy (PEG) is the procedure of choice in establishing a permanent feeding tube in patients with chronic severe dysphagia. This is the first prospective randomized study in adults comparing PEG with radiologically inserted gastrostomy (RIG).
Methods:
Randomization of 106 patients, eligible for both techniques, to PEG (pull method) or RIG. The groups were comparable in terms of age, body mass index, and underlying diseases. Adverse events were reported 10 and 30 days after the operative procedure, and mortality was up until 6 months. The validated European Quality of life 5 Dimensions 3 level version (EQ-5D) questionnaire was used for health status measurements.
Results:
The procedures were successfully completed in all patients. The median operative time was 10 min for PEG and 20 min for RIG (p < 0.001). The overall rate of adverse events was lower for PEG (22%) than for RIG (51%, p = 0.002), mostly due to less local self-limiting stoma reactions and tube problems. The 30-day mortality was lower after PEG (2% versus 14%, p = 0.020). Patient-scored health status remained low for the entire cohort, with an EQ-5D utility index of 0.164. Self-rated health was low but improved in the RIG group (52.5 from 41.1, out of 100).
Conclusion:
PEG can be recommended as the primary procedure in patients in need of a feeding gastrostomy, mainly due to a lower frequency of tube complications. However, as the two techniques complement each other, RIG is also a valid alternative method.
Clinical Trial Registration:
International Standard Randomized Controlled Trial Number ISRCTN17642761. https://doi.org/10.1186/ISRCTN17642761.
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