TY - JOUR

T1 - Efficacy of dexamethasone in reducing the postembolisation syndrome in men undergoing prostatic artery embolisation for benign prostatic hyperplasia

T2 - Protocol for a single-centre, randomised, double-blind, placebo-controlled trial - The DEXAPAE study

AU - Svarc, Petra

AU - Stroomberg, Hein Vincent

AU - Juhl Jensen, Ruben

AU - Frevert, Susanne

AU - Håkan Lindh, Mats

AU - Taudorf, Mikkel

AU - Brasso, Klaus

AU - Lönn, Lars

AU - Røder, Martin Andreas

N1 - Publisher Copyright: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2021

Y1 - 2021

N2 - Introduction Postembolisation syndrome (PES) is the most common side effect of vascular embolisation of solid organs. Although prophylactic corticosteroids are known to reduce the incidence and severity of PES, no trials investigating their efficacy have been conducted in men undergoing prostatic artery embolisation (PAE). We postulate that steroids can have a similar effect in reducing PES after PAE. This paper describes the rationale and detailed protocol for a randomised controlled trial evaluating the efficacy of dexamethasone (DEXA) in reducing PES after PAE. Methods and analysis In this single-centre, randomised, double-blind, placebo-controlled trial, we will enrol 60 individuals undergoing PAE for benign prostatic hyperplasia. Participants will be randomised to receive IV DEXA (24 mg) or placebo (saline). The primary outcomes will be postprocedural fever, pain and quality of life. The secondary outcomes will include postprocedural nausea, postprocedural medicine usage, laboratory parameters (C reactive protein, prostate-specific antigen) and early PAE results. Ethics and dissemination Ethics approval was obtained from the Danish Committee on Health Research Ethics in the Capital Region (H-20025910). The results from this trial will be disseminated through publication in peer-reviewed journals and national and international presentations.

AB - Introduction Postembolisation syndrome (PES) is the most common side effect of vascular embolisation of solid organs. Although prophylactic corticosteroids are known to reduce the incidence and severity of PES, no trials investigating their efficacy have been conducted in men undergoing prostatic artery embolisation (PAE). We postulate that steroids can have a similar effect in reducing PES after PAE. This paper describes the rationale and detailed protocol for a randomised controlled trial evaluating the efficacy of dexamethasone (DEXA) in reducing PES after PAE. Methods and analysis In this single-centre, randomised, double-blind, placebo-controlled trial, we will enrol 60 individuals undergoing PAE for benign prostatic hyperplasia. Participants will be randomised to receive IV DEXA (24 mg) or placebo (saline). The primary outcomes will be postprocedural fever, pain and quality of life. The secondary outcomes will include postprocedural nausea, postprocedural medicine usage, laboratory parameters (C reactive protein, prostate-specific antigen) and early PAE results. Ethics and dissemination Ethics approval was obtained from the Danish Committee on Health Research Ethics in the Capital Region (H-20025910). The results from this trial will be disseminated through publication in peer-reviewed journals and national and international presentations.

KW - adult urology

KW - interventional radiology

KW - prostate disease

U2 - 10.1136/bmjopen-2020-047878

DO - 10.1136/bmjopen-2020-047878

M3 - Journal article

C2 - 34725072

AN - SCOPUS:85118953525

VL - 11

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 11

M1 - e047878

ER -