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Originalité :
Très original
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Immédiatement
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Nom du veilleur :
Professeur Pierre-Emmanuel RAUTOU
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Gastroenterology
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2018/09
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2018 Sep;155(3):752-759.e5.
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doi: 10.1053/j.gastro.2018.05.034.
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No Superiority of Stents vs Balloon Dilatation for Dominant Strictures in Patients With PrimarySclerosing Cholangitis.
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Ponsioen CY, Arnelo U, Bergquist A, Rauws EA, Paulsen V, Cantú P, Parzanese I, De Vries EM, van Munster KN, Said K, Chazouillères O, Desaint B, Kemgang A, Färkkilä M, Van der Merwe S, Van Steenbergen W, Marschall HU, Stotzer PO, Thorburn D, Pereira SP, Aabakken L
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https://www.ncbi.nlm.nih.gov/pubmed/29803836
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Abstract
BACKGROUND & AIMS:
Dominant strictures occur in approximately 50% of patients with primary sclerosing cholangitis (PSC). Short-term stents have been reported to produce longer resolution of dominant strictures than single-balloon dilatation. We performed a prospective study to compare the efficacy and safety of balloon dilatation vs short-term stents in patients with non-end-stage PSC.
METHODS:
We performed an open-label trial of patients with PSC undergoing therapeutic endoscopic retrograde cholangiopancreatography (ERCP) at 9 tertiary-care centers in Europe, from July 2011 through April 2016. Patients found to have a dominant stricture during ERCP were randomly assigned to groups that underwent balloon dilatation (n = 31) or stent placement for a maximum of 2 weeks (n = 34); patients were followed for 24 months. The primary outcome was the cumulative recurrence-free patency of the primary dominant strictures.
RESULTS:
Study recruitment was terminated after a planned interim analysis because of futility and differences in treatment-related serious adverse events (SAEs) between groups. The cumulative recurrence-free rate did not differ significantly between groups (0.34 for the stent group and 0.30 for the balloon dilatation group at 24 months; P = 1.0). Most patients in both groups had reductions in symptoms at 3 months after the procedure. There were 17 treatment-related SAEs: post-ERCP pancreatitis in 9 patients and bacterial cholangitis in 4 patients. SAEs occurred in 15 patients in the stent group (45%) and in only 2 patients in the balloon dilatation group (6.7%) (odds ratio, 11.7; 95% confidence interval, 2.4-57.2; P = .001).
CONCLUSIONS:
In a multicenter randomized trial of patients with PSC and a dominant stricture, short-term stents were not superior to balloon dilatation and were associated with a significantly higher occurrence of treatment-related SAEs. Balloon dilatation should be the initial treatment of choice for dominant strictures in patients with PSC. This may be particularly relevant to patients with an intact papilla. ClinicalTrials.gov no. NCT01398917.
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Chez les malades atteints de cholangite sclérosante primitive ayant une sténose biliaire dominante, quelle est la sûreté et efficacité de dilatations simples au ballonnet en comparaison avec un calibrage court par prothèse biliaire ?
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Cette étude randomisée contrôlée a été interrompue après inclusion de 65 malades en raison de différence entre les 2 bras dans le nombre d’effets secondaires : si le taux de récidive était similaire entre les 2 groupes, les effets indésirables (pancréatite aiguë, angiocholite) étaient beaucoup plus fréquents dans le groupe traité par prothèse biliaire.
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Chez les malades avec cholangite sclérosante primitive et sténose biliaire dominante, la dilatation simple sans prothèse doit être le traitement de première ligne.
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