Chyme reinfusion using The Insides® System to reduce parenteral nutrition dependence in type 2 intestinal failure: multicentre randomized clinical trial (REINFUSE)
In brief
By 60 days, 42% on chyme reinfusion had stopped parenteral nutrition
In this small randomized trial, 10 of 23 patients receiving device-assisted chyme reinfusion had stopped parenteral nutrition by day 60, compared with none receiving standard care. The primary 30-day target was not statistically significant, and 11 device-related adverse events occurred, including one severe event; larger studies must clarify who benefits and the treatment's safety.
- Journal
- BJS open (Q1)
- Published
- 4 September 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Tony G E Milne, Simon Lal, Arun Abraham, Kirstine Farrer, Jonathan Evans, Kathryn Thomas, et al.
- PMID
- 42911833
- DOI
- 10.1093/bjsopen/zrag158
Why clinicians should know about it
- Picked for Surgery (top studies of the week, 25 October 2026): Randomized trial addresses intestinal failure after enterostomy or fistula
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. RESULTS: Out of 44 patients assessed for eligibility, 39 patients were randomized (26 CRT plus standard care-active, 13 standard care control). At day 30, 8 of 26 active participants (31%) achieved the primary endpoint versus no controls (P = 0.035). By day 60, 10 of 23 active participants (42%) had completely ceased PN versus no controls (P = 0.011), with median intestinal losses reduced by 1344 ml/day at day 30 (P = 0.005) and 1450 ml/day at day 60 (P = 0.026 between group). There were 11 device-related adverse events, one severe and all resolved. There was one death unrelated to the device. CONCLUSION: Although the study's primary endpoint did not reach statistical significance, at 30 days, 31% of participants undergoing CRT had reduced PN calories by 50%, and at 60 days > 40% of CRT patients had completely ceased PN, with an acceptable safety profile. REGISTRATION NUMBER: NCT04577456 (http://www.clinicaltrials.gov).
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.