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

Area of Science:

• Gastroenterology
• Medical Devices
• Clinical Trials

Background:

• Percutaneous endoscopic gastrostomy (PEG) tubes are crucial for long-term enteral nutrition.
• Limited data exists on the long-term performance and longevity of various PEG replacement tubes.

Purpose of the Study:

• To evaluate and compare the long-term performance and longevity of five different PEG replacement tube models.
• To identify common failure modes and factors affecting PEG tube lifespan.

Main Methods:

• A randomized, partially blinded trial involving 100 patients receiving home enteral nutrition.
• Patients were allocated to one of five intervention groups, each testing a specific PEG device.
• Tube longevity was the primary outcome, analyzed using Kaplan-Meier curves and Cox regression.

Main Results:

• All tested PEG tube models experienced common dysfunctions, including fastener sliding (57.0%) and balloon rupture (32.0%).
• The Wilson Cook model demonstrated the longest longevity (158.0 ± 10.0 days), primarily due to fewer balloon ruptures.
• No significant morbidity or mortality was associated with any of the tested PEG tubes.

Conclusions:

• PEG tube replacement is a safe procedure, but current devices exhibit frequent issues that compromise longevity.
• Improvements are needed in components such as the cap, feeding line, external clamp, and tube fastener.
• Notably, balloon performance is a critical factor influencing PEG tube durability and requires specific attention for future designs.