No Superiority of Stents vs Balloon Dilatation for Dominant Strictures in Patients With Primary Sclerosing Cholangitis

Cyriel Y. Ponsioen, Urban Arnelo, Annika Bergquist, Erik A. Rauws, Vemund Paulsen, Paolo Cantú, Ilaria Parzanese, Elisabeth M. De Vries, Kim N. van Munster, Karouk Said, Olivier Chazouillères, Benoit Desaint, Astrid Kemgang, Martti Färkkilä, Schalk Van der Merwe, Werner Van Steenbergen, Hanns Ulrich Marschall, Per Ove Stotzer, Douglas Thorburn, Stephen P. PereiraLars Aabakken

Research output: Contribution to journalArticle

16 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)752-759.e5
JournalGastroenterology
Volume155
Issue number3
DOIs
Publication statusPublished - Sep 1 2018

Fingerprint

Sclerosing Cholangitis
Stents
Dilatation
Pathologic Constriction
Endoscopic Retrograde Cholangiopancreatography
Medical Futility
Therapeutics
Recurrence
Cholangitis
Tertiary Care Centers
Pancreatitis
Multicenter Studies

Keywords

  • Biliary
  • Drainage
  • Surgery
  • Temporary Stent

ASJC Scopus subject areas

  • Gastroenterology

Cite this

No Superiority of Stents vs Balloon Dilatation for Dominant Strictures in Patients With Primary Sclerosing Cholangitis. / Ponsioen, Cyriel Y.; Arnelo, Urban; Bergquist, Annika; Rauws, Erik A.; Paulsen, Vemund; Cantú, Paolo; Parzanese, Ilaria; De Vries, Elisabeth M.; van Munster, Kim N.; Said, Karouk; Chazouillères, Olivier; Desaint, Benoit; Kemgang, Astrid; Färkkilä, Martti; Van der Merwe, Schalk; Van Steenbergen, Werner; Marschall, Hanns Ulrich; Stotzer, Per Ove; Thorburn, Douglas; Pereira, Stephen P.; Aabakken, Lars.

In: Gastroenterology, Vol. 155, No. 3, 01.09.2018, p. 752-759.e5.

Research output: Contribution to journalArticle

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 2018, 'No Superiority of Stents vs Balloon Dilatation for Dominant Strictures in Patients With Primary Sclerosing Cholangitis', Gastroenterology, vol. 155, no. 3, pp. 752-759.e5. https://doi.org/10.1053/j.gastro.2018.05.034
Ponsioen, Cyriel Y. ; Arnelo, Urban ; Bergquist, Annika ; Rauws, Erik A. ; Paulsen, Vemund ; Cantú, Paolo ; Parzanese, Ilaria ; De Vries, Elisabeth M. ; van Munster, Kim N. ; Said, Karouk ; Chazouillères, Olivier ; Desaint, Benoit ; Kemgang, Astrid ; Färkkilä, Martti ; Van der Merwe, Schalk ; Van Steenbergen, Werner ; Marschall, Hanns Ulrich ; Stotzer, Per Ove ; Thorburn, Douglas ; Pereira, Stephen P. ; Aabakken, Lars. / No Superiority of Stents vs Balloon Dilatation for Dominant Strictures in Patients With Primary Sclerosing Cholangitis. In: Gastroenterology. 2018 ; Vol. 155, No. 3. pp. 752-759.e5.
@article{6dc0688e7d1141a194db4f0a4e8859c6,
title = "No Superiority of Stents vs Balloon Dilatation for Dominant Strictures in Patients With Primary Sclerosing Cholangitis",
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.",
keywords = "Biliary, Drainage, Surgery, Temporary Stent",
author = "Ponsioen, {Cyriel Y.} and Urban Arnelo and Annika Bergquist and Rauws, {Erik A.} and Vemund Paulsen and Paolo Cant{\'u} and Ilaria Parzanese and {De Vries}, {Elisabeth M.} and {van Munster}, {Kim N.} and Karouk Said and Olivier Chazouill{\`e}res and Benoit Desaint and Astrid Kemgang and Martti F{\"a}rkkil{\"a} and {Van der Merwe}, Schalk and {Van Steenbergen}, Werner and Marschall, {Hanns Ulrich} and Stotzer, {Per Ove} and Douglas Thorburn and Pereira, {Stephen P.} and Lars Aabakken",
year = "2018",
month = "9",
day = "1",
doi = "10.1053/j.gastro.2018.05.034",
language = "English",
volume = "155",
pages = "752--759.e5",
journal = "Gastroenterology",
issn = "0016-5085",
publisher = "W.B. Saunders Ltd",
number = "3",

}

TY - JOUR

T1 - No Superiority of Stents vs Balloon Dilatation for Dominant Strictures in Patients With Primary Sclerosing Cholangitis

AU - Ponsioen, Cyriel Y.

AU - Arnelo, Urban

AU - Bergquist, Annika

AU - Rauws, Erik A.

AU - Paulsen, Vemund

AU - Cantú, Paolo

AU - Parzanese, Ilaria

AU - De Vries, Elisabeth M.

AU - van Munster, Kim N.

AU - Said, Karouk

AU - Chazouillères, Olivier

AU - Desaint, Benoit

AU - Kemgang, Astrid

AU - Färkkilä, Martti

AU - Van der Merwe, Schalk

AU - Van Steenbergen, Werner

AU - Marschall, Hanns Ulrich

AU - Stotzer, Per Ove

AU - Thorburn, Douglas

AU - Pereira, Stephen P.

AU - Aabakken, Lars

PY - 2018/9/1

Y1 - 2018/9/1

N2 - 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.

AB - 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.

KW - Biliary

KW - Drainage

KW - Surgery

KW - Temporary Stent

UR - http://www.scopus.com/inward/record.url?scp=85051833978&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85051833978&partnerID=8YFLogxK

U2 - 10.1053/j.gastro.2018.05.034

DO - 10.1053/j.gastro.2018.05.034

M3 - Article

AN - SCOPUS:85051833978

VL - 155

SP - 752-759.e5

JO - Gastroenterology

JF - Gastroenterology

SN - 0016-5085

IS - 3

ER -