BJS open
Chyme reinfusion using The Insides® System to reduce parenteral nutrition dependence in type 2 intestinal failure: multicentre randomized clinical trial (REINFUSE)
By Milne TGE, Lal S, Abraham A and 15 others.
Abstract
Background
Patients with type 2 intestinal failure due to double enterostomy or enterocutaneous fistula requiring parenteral nutrition (PN), are at higher risks of catheter sepsis, venous thrombosis, and liver disease. Chyme reinfusion therapy (CRT) may reduce PN dependence but has not been evaluated in a randomized clinical trial. This study assessed whether device-assisted CRT using The Insides® System reduces PN requirements.
Methods
This multicentre, open-label randomized clinical trial enrolled PN-dependent adults with type 2 intestinal failure due to double enterostomy or enterocutaneous fistula across 12 centres in the UK and USA between 2022 and 2025. Patients with insufficient distal limb length, proximal bowel obstruction, active sepsis, or severe hepatorenal failure were excluded. Participants were block randomized 2 : 1 to device-assisted CRT plus standard care (active) or standard care (control). The primary endpoint was ≥ 50% reduction in PN caloric intake at 30 days, using an intention-to-treat analysis, for a comparison between randomized groups using a two-tailed P value of 0.025 to allow for a single interim analysis. Secondary outcomes were rate of PN cessation at 30 and 60 days, quality of life, and adverse events.