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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
Chyme reinfusion using The Insides® System to reduce parenteral nutrition dependence in type 2 intestinal failure:
Tony G E Milne1, Simon Lal2, Arun Abraham2
1Department of Colorectal Surgery, Royal Brisbane and Women's Hospital, Brisbane, Australia.
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).
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