Long-term outcomes after temporary placement of a self-expanding fully covered metal stent for benign biliary strictures secondary to chronic pancreatitis.

Adult Bile Duct Diseases / etiology Cholangiopancreatography, Endoscopic Retrograde Cholangitis / epidemiology Cholestasis / etiology Constriction, Pathologic / etiology Device Removal Female Humans Male Middle Aged Pancreatitis, Chronic / complications Postoperative Complications / epidemiology Recurrence Self Expandable Metallic Stents Treatment Outcome

Journal

Gastrointestinal endoscopy

ISSN: 1097-6779

Titre abrégé: Gastrointest Endosc

Pays: United States

ID NLM: 0010505

Informations de publication

Date de publication:
02 2020

Historique:

received: 20 04 2019

accepted: 19 08 2019

pubmed: 9 9 2019

medline: 26 1 2021

entrez: 9 9 2019

Statut: ppublish

Résumé

Temporary single, fully covered self-expanding metal stent (FCSEMS) placement for benign biliary strictures (BBSs) associated with chronic pancreatitis (CP) may require fewer interventions than endotherapy with multiple plastic stents and may carry less morbidity than biliary diversion surgery. This study aimed to assess long-term outcomes in CP-associated BBSs after FCSEMS placement and removal. In this open-label, multinational, prospective study, subjects with CP and a BBS treated with FCSEMS placement with scheduled removal at 10 to 12 months were followed for 5 years after FCSEMS indwell. Kaplan-Meier analyses assessed BBS resolution and cumulative probability of freedom from recurrent stent placement to 5 years after FCSEMS indwell. One hundred eighteen patients were eligible for FCSEMS removal. At a median of 58 months (interquartile range, 44-64) post-FCSEMS indwell, the probability of remaining stent-free was 61.6% (95% confidence interval [CI], 52.5%-70.7%). In 94 patients whose BBSs resolved at the end of FCSEMS indwell, the probability of remaining stent-free 5 years later was 77.4% (95% CI, 68.4%-86.4%). Serious stent-related adverse events occurred in 27 of 118 patients (22.9%); all resolved with medical therapy or repeated endoscopy. Multivariate analysis identified severe CP (hazard ratio, 2.4; 95% CI, 1.0-5.6; P = .046) and longer stricture length (hazard ratio, 1.2; 95% CI, 1.0-1.4; P = .022) as predictors of stricture recurrence. In patients with symptomatic BBSs secondary to CP, 5 years after placement of a single FCSEMS intended for 10 to 12 months indwell, more than 60% remained asymptomatic and stent-free with an acceptable safety profile. Temporary placement of a single FCSEMS may be considered as first-line treatment for patients with CP and BBSs. (Clinical trial registration number: NCT01014390.).

Sections du résumé

BACKGROUND AND AIMS

METHODS

In this open-label, multinational, prospective study, subjects with CP and a BBS treated with FCSEMS placement with scheduled removal at 10 to 12 months were followed for 5 years after FCSEMS indwell. Kaplan-Meier analyses assessed BBS resolution and cumulative probability of freedom from recurrent stent placement to 5 years after FCSEMS indwell.

RESULTS

One hundred eighteen patients were eligible for FCSEMS removal. At a median of 58 months (interquartile range, 44-64) post-FCSEMS indwell, the probability of remaining stent-free was 61.6% (95% confidence interval [CI], 52.5%-70.7%). In 94 patients whose BBSs resolved at the end of FCSEMS indwell, the probability of remaining stent-free 5 years later was 77.4% (95% CI, 68.4%-86.4%). Serious stent-related adverse events occurred in 27 of 118 patients (22.9%); all resolved with medical therapy or repeated endoscopy. Multivariate analysis identified severe CP (hazard ratio, 2.4; 95% CI, 1.0-5.6; P = .046) and longer stricture length (hazard ratio, 1.2; 95% CI, 1.0-1.4; P = .022) as predictors of stricture recurrence.

CONCLUSION

In patients with symptomatic BBSs secondary to CP, 5 years after placement of a single FCSEMS intended for 10 to 12 months indwell, more than 60% remained asymptomatic and stent-free with an acceptable safety profile. Temporary placement of a single FCSEMS may be considered as first-line treatment for patients with CP and BBSs. (Clinical trial registration number: NCT01014390.).

Identifiants

DOI: 10.1016/j.gie.2019.08.037 PMID: 31494135

pubmed: 31494135

pii: S0016-5107(19)32207-2

doi: 10.1016/j.gie.2019.08.037

pii:

doi:

Banques de données

ClinicalTrials.gov

['NCT01014390']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

Pagination

361-369.e3

Investigateurs

Michael J Bourke (MJ)

Stephen J Williams (SJ)

Andreas Püspök (A)

Werner Dolak (W)

Barbara Tribl (B)

Jacques Devière (J)

Daniel Blero (D)

Vincent Huberty (V)

Myriam Delhaye (M)

Arnaud Lemmers (A)

Olivier Le Moine (O)

Marianna Arvanitakis (M)

André Roy (A)

Marylène Plasse (M)

Paul P Kortan (PP)

Gary May (G)

Thierry Ponchon (T)

Vincent Lepilliez (V)

Horst Neuhaus (H)

Brigitte Schumacher (B)

Jean Pierre Charton (JP)

Christian Gerges (C)

Torsten Beyna (T)

D Nageshwar Reddy (DN)

Sundeep Lakhtakia (S)

Guido Costamagna (G)

Andrea Tringali (A)

Vincenzo Perri (V)

Pietro Familiari (P)

Massimiliano Mutignani (M)

Marco J Bruno (MJ)

Jan W Poley (JW)

Ferrán González-Huix Lladó (F)

Montserrat Figa Fransech (MF)

Joyce Peetermans (J)

Matthew Rousseau (M)

Thomas Bowman (T)

David Carr-Locke (D)

Commentaires et corrections

Type : CommentIn