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Clinical trial: The effectiveness of long-acting somatostatin analogue for output reduction of high-output intestinal fistula or small bowel enterostomy. A randomised controlled trial.

Clinical trial: The effectiveness of long-acting somatostatin analogue for output reduction of high-output intestinal fistula or small bowel enterostomy. A randomised controlled trial.

Authors :
Timmer AS
de Vries F
Gans SL
Zwanenburg PR
Bemelman WA
Dijkgraaf MGW
Dijkstra G
van der Heide F
Haveman JW
Serlie MJ
Boermeester MA
Source :
Alimentary pharmacology & therapeutics [Aliment Pharmacol Ther] 2024 Sep; Vol. 60 (6), pp. 727-736. Date of Electronic Publication: 2024 Jul 11.
Publication Year :
2024

Abstract

Background: High-output intestinal fistulas and small bowel enterostomies are associated with morbidity and mortality. Current standard treatment for output reduction consists of fluid and dietary restrictions and medical therapy. There is conflicting evidence regarding the use of somatostatin analogues for output reduction.<br />Aim: The aim of this study is to investigate whether lanreotide, added to current standard treatment, further reduces intestinal output in patients with high-output fistulas and enterostomies.<br />Methods: This was an open-label, multicentre, randomised controlled trial. Adult patients with a high-output intestinal fistula (>500 mL/24 h) or small bowel enterostomy (>1500 mL/24 h) more than 4 weeks post-surgery and receiving standard medical treatment (dietary- and fluid restriction, PPI, loperamide and codeine) for at least 2 weeks were eligible for inclusion. We randomised patients 1:1 between continuing standard treatment (control), and subcutaneous lanreotide 120 mg every 4 weeks with standard treatment. The primary outcome was the number of responders, with response defined as an output reduction of ≥25%, 8 weeks after randomisation. We also investigated the proportional change in output.<br />Results: We randomised 40 patients; 17 had a fistula and 23 a small bowel enterostomy. There were 9/20 responders in the intervention group and 2/20 in the control group (p = 0.013). The proportional output reduction was -26% (IQR -4 to -38) in the intervention group, compared to an increase of 4% (IQR 20 to -13) in the control group (p = 0.004).<br />Conclusions: In patients with a high-output fistula or small bowel enterostomy, addition of lanreotide to current standard treatment can provide a clinically relevant output reduction.<br />Trial Registration: EudraCT: 2013-003998-10.<br /> (© 2024 The Author(s). Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.)

Details

Language :
English
ISSN :
1365-2036
Volume :
60
Issue :
6
Database :
MEDLINE
Journal :
Alimentary pharmacology & therapeutics
Publication Type :
Academic Journal
Accession number :
38993030
Full Text :
https://doi.org/10.1111/apt.18166