No superiority of stents vs balloon dilatation for dominant strictures in patients with primary sclerosing cholangitis
Open accessAbstract
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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In a multicentre, randomised trial of people with PSC and a high-grade stricture, short-term stents were not superior to balloon dilatation in regard to recurrence-free patency but were associated with a markedly higher occurrence of treatment-related adverse events including bacterial cholangitis (12% vs. 3%).
“In a multicentre, randomised trial of people with PSC and a high-grade stricture, short-term stents were not superior to balloon dilatation in regard to recurrence-free patency but were associated with a markedly higher occurrence of treatment-related adverse events including bacterial cholangitis (12% vs. 3%).228”
From EASL Clinical Practice Guidelines on sclerosing cholangitis (2022) · cites this paper as [228]
A recent randomised trial demonstrated that stent placement was associated with increased risk of serious adverse events such as pancreatitis and bacterial cholangitis.
“However, a recent randomised trial demonstrated that stent placement was associated with increased risk of serious adverse events such as pancreatitis and bacterial cholangitis.228”
From EASL Clinical Practice Guidelines on sclerosing cholangitis (2022) · cites this paper as [228]
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- Authors
- Ponsioen, C. Y., Arnelo, U., Bergquist, A., Rauws, E. A., Paulsen, V., Cantú, P., Parzanese, I., De Vries, E. M., van Munster, K. N., Said, K., Chazouillères, O., Desaint, B., Kemgang, A., Färkkilä, M., Van der Merwe, S., Van Steenbergen, W., Marschall, H.-U., Stotzer, P.-O., Thorburn, D., Pereira, S. P., & Aabakken, L.
- Affiliations
- Amsterdam UMC Location University of Amsterdam (NL)
- Karolinska University Hospital (SE)
- Amsterdam University Medical Centers (NL)
- Oslo University Hospital (NO)
- University of Milan (IT)
- Hôpital Saint-Antoine (FR)
- Helsinki University Hospital (FI)
- The Royal Free Hospital (GB)
- Corresponding author
- Ponsioen, Cyriel Y.
- ORCID
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2018-09
- Volume
- 155
- Issue
- 3
- Pages
- 752-759.e5
- ISSN
- 0016-5085 (ISSN-L)
- OpenAlex
- W2803499191
- Cited by
- 112
- References
- 20
- Citations by year
- 2026: 15 · 2025: 13 · 2024: 12 · 2023: 11 · 2022: 12 · 2021: 12 · 2020: 19 · 2019: 16 · 2018: 2
- FWCI
- 7.67
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- Lirias (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Työväentutkimus Vuosikirja (submittedVersion)
- Pure Amsterdam UMC (submittedVersion)
- Funders
- Takeda Pharmaceutical Company
- Boston Scientific Corporation
- AbbVie
- Topics
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Gallbladder and Bile Duct Disorders
- Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
- Keywords
- primary sclerosing cholangitis, biliary stent, balloon dilation, endoscopic stenting, post-ERCP pancreatitis, bacterial cholangitis, treatment-related adverse events
- MeSH terms
- Adult, Biliary Tract, Catheterization, Cholangiopancreatography, Endoscopic Retrograde, Constriction, Pathologic, Dilatation, Female, Humans, Male, Middle Aged, Recurrence, Cholangitis, Sclerosing, Stents, Treatment Outcome, Young Adult
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