Is Lanreotide Really Useful in High Output Stoma? Comparison between Lanreotide to Conventional Antidiarrheal Treatment Alone

Abstract

Background

The incidence of high-output stoma (HOS) was reported to be approximately 3 to 16% in the literature, and HOS can cause dehydration. This complication is often severe enough to warrant hospital readmission and may result in renal failure. The aim of this study was to show a decrease of 50% in ileostomy output in the experimental arm using lanreotide treatment.

Methods

Patients with an ileostomy output ≥ 1.5 l/24 hours were included in this prospective, open, multicentre randomized trial. Patients were randomly allocated between treatment arms with either lanreotide (LAN) and antidiarrhoeal treatments (TAD) (LAN-TAD group) or antidiarrhoeal treatments only (TADS group). The primary outcome was ileostomy output after 72 days. The secondary endpoints were ileostomy output during the first 6 days, blood urea and creatinine values, hospital length of stay and serious adverse events.

Results

In the per-protocol analysis, there were nine patients in the control group (TADS) and six patients in the experimental group (TAD-LAN group). The stoma outputs at Day 3 (D3) in the experimental and control groups were 1,900 ± 855.7 mL and 1,728.6 ± 845.5 mL, respectively (p = 0.2). No differences were found concerning stoma output at D6, renal function, or hospital length of stay between the two groups.

Conclusion

The trial was prematurely stopped due to the low number of patients included. The question of the usefulness of somatostatin analogues in HOS persists, especially as the cost of this treatment is high, and there is a lack of evidence of its effectiveness.

Keywords:

• Somatostatin analogues
• high-output stoma
• dehydration
• lanreotide

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Correction

Acknowledgments

The authors thank the Strasbourg DRCI (Direction de la Recherche Clinique et de l’Innovation) team for the management of ILEHOS trial: Mrs. Caroline Bouvrais, Mrs. Christelle Back, Mme Barbara Jung, Mr. Stéphane Hecketsweiler, Mr. Khaled Bennedif. The authors thank Dr. Hefzi Alratrout for his help.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

The industry sponsor was aware of inclusions number, but the preliminary results of this study were confidential and were not known by the sponsor. The industrial sponsor stopped the financial funding before the end of the trial due to poor accrual.

IPSEN grants.