Trial reportBJS open2026
Chyme reinfusion using The Insides® System to reduce parenteral nutrition dependence in type 2 intestinal failure: multicentre randomized clinical trial (REINFUSE).
Trial report in BJS open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04577456 (Pivotal Study to Evaluate the Safety and Efficacy of the Insides™ System in the Treatment of Subjects With a Double Enterostomy and/or Enterocutaneous Fistula and Type 2 Intestinal Failure.), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Pivotal Study to Evaluate the Safety and Efficacy of the Insides™ System in the Treatment of Subjects With a Double Enterostomy and/or Enterocutaneous Fistula and Type 2 Intestinal Failure.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
Abstract
backgroundPatients 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.
methodsThis 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.
resultsOut 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.
conclusionAlthough 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).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.