Skip to content
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
No Superiority of Stents vs Balloon Dilatation for Dominant Strictures in Patients With Primary Sclerosing Cholangitis
Gastroenterology, Volume 155, No. 3, Year 2018
Notification
URL copied to clipboard!
Description
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. © 2018 AGA Institute
Authors & Co-Authors
Ponsioen, Cyriel Y.
Netherlands, Amsterdam
Amsterdam Umc - University of Amsterdam
Arnelo, Urban
Sweden, Stockholm
Karolinska Institutet
Chazouillerès, Olivier
France, Paris
Hôpital Saint-antoine
Färkkilä, Martti A.
Finland, Helsinki
Helsinki University Hospital
van der Merwe, Schalk Willem
Unknown Affiliation
van Steenbergen, Werner
Unknown Affiliation
Marschall, Hanns Ulrich
Unknown Affiliation
Thorburn, Douglas
United Kingdom, London
The Royal Free Hospital
Aabakken, Lars E.
Norway, Oslo
Rikshospitalet-radiumhospitalet hf
Statistics
Citations: 61
Authors: 9
Affiliations: 7
Identifiers
Doi:
10.1053/j.gastro.2018.05.034
ISSN:
00165085
Study Design
Cohort Study
Case-Control Study