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
Fuente:
Wiley Open Access
Saved in:
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Artículo Open Access |
| Published: |
Wiley
2024
|
| Subjects: | |
| Online Access: | |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1867005784600084480 |
|---|---|
| author | Allard S. Timmer Fleur de Vries Sarah L. Gans Pieter R. Zwanenburg Willem A. Bemelman Marcel G. W. Dijkgraaf Gerard Dijkstra Frans van der Heide Jan Willem Haveman Mireille J. Serlie Marja A. Boermeester |
| author_facet | Allard S. Timmer Fleur de Vries Sarah L. Gans Pieter R. Zwanenburg Willem A. Bemelman Marcel G. W. Dijkgraaf Gerard Dijkstra Frans van der Heide Jan Willem Haveman Mireille J. Serlie Marja A. Boermeester Allard S. Timmer Fleur de Vries Sarah L. Gans Pieter R. Zwanenburg Willem A. Bemelman Marcel G. W. Dijkgraaf Gerard Dijkstra Frans van der Heide Jan Willem Haveman Mireille J. Serlie Marja A. Boermeester |
| collection | Wiley Open Access |
| contents | 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 Allard S. Timmer Fleur de Vries Sarah L. Gans Pieter R. Zwanenburg Willem A. Bemelman Marcel G. W. Dijkgraaf Gerard Dijkstra Frans van der Heide Jan Willem Haveman Mireille J. Serlie Marja A. Boermeester Alimentary Pharmacology & Therapeutics Summary 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. 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. 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. 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). 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. Trial registration EudraCT: 2013‐003998‐10. 10.1111/apt.18166 http://creativecommons.org/licenses/by-nc/4.0/ |
| doi_str_mv | 10.1111/apt.18166 |
| format | Artículo Open Access |
| id | wiley_oa_10_1111_apt_18166 |
| institution | Wiley Open Access |
| license_str_mv | http://creativecommons.org/licenses/by-nc/4.0/ |
| publishDate | 2024 |
| publisher | Wiley |
| record_format | wiley_oa |
| spellingShingle | 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 Allard S. Timmer Fleur de Vries Sarah L. Gans Pieter R. Zwanenburg Willem A. Bemelman Marcel G. W. Dijkgraaf Gerard Dijkstra Frans van der Heide Jan Willem Haveman Mireille J. Serlie Marja A. Boermeester Alimentary Pharmacology & Therapeutics 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 Allard S. Timmer Fleur de Vries Sarah L. Gans Pieter R. Zwanenburg Willem A. Bemelman Marcel G. W. Dijkgraaf Gerard Dijkstra Frans van der Heide Jan Willem Haveman Mireille J. Serlie Marja A. Boermeester Alimentary Pharmacology & Therapeutics Summary 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. 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. 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. 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). 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. Trial registration EudraCT: 2013‐003998‐10. 10.1111/apt.18166 http://creativecommons.org/licenses/by-nc/4.0/ |
| title | 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 |
| topic | Alimentary Pharmacology & Therapeutics |
| url | https://onlinelibrary.wiley.com/doi/10.1111/apt.18166 |