Evidence map›Paper›PMID 31830897›Full record

ArticleBMC gastroenterology2019

Treatment of post-cholecystectomy biliary strictures with fully-covered self-expanding metal stents - results after 5 years of follow-up.

Andrea Tringali, D Nageshwar Reddy, Thierry Ponchon, Horst Neuhaus, Ferrán González-Huix Lladó, Claudio Navarrete, Marco J Bruno, Paul P Kortan, Sundeep Lakhtakia, Joyce Peetermans and 5 more

Registry-linked trialOpen access · goldAbstract readMulticenter Study
In one paragraph

Article in BMC gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01014390 (A Multi-Center, Prospective Study of the WallFlex Biliary RX Fully Covered Stent for the Treatment of Benign Biliary Strictures), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.4field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01014390 phase3completednot on this map

A Multi-Center, Prospective Study of the WallFlex Biliary RX Fully Covered Stent for the Treatment of Benign Biliary Strictures

TypeinterventionalSponsorBoston Scientific CorporationRan2009 to 2017Enrolled187ConditionsBiliary StrictureArmsWallFlex Biliary RX Fully Covered Stent System
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 25 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Observational
  5. Review
  6. Article
  7. Biliary and pancreatic stents.iGIE : innovation, investigation and insights · 2023
    Article
  8. Article
  9. Review
  10. Endoscopic treatment of benign biliary stricture using different stents: a systematic review and meta-analysis.Wideochirurgia i inne techniki maloinwazyjne = Videosurgery and other miniinvasive techniques · 2022
    Article
  11. Trans-papillary bilio-pancreatic stenting: When how and which stent.Frontiers in gastroenterology (Lausanne, Switzerland) · 2022
    Review
  12. Article
  13. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 9 institutions in 9 countries.

Andrea TringaliFondazione Policlinico Universitario A. Gemelli IRCCS, Digestive Endoscopy Unit, Rome, Italy. andrea.tringali@unicatt.it.ORCID http://orcid.org/0000-0002-9614-3449
D Nageshwar ReddyGastroenterology and Therapeutic Endoscopy, Asian Institute of Gastroenterology, Hyderabad, India.
Thierry PonchonService de Gastroentérologie et d'Endoscopie Digestive, Hôpital Edouard Herriot, Lyon, France.
Horst NeuhausMedizinische Klinik, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany.
Ferrán González-Huix LladóUnidad de Endoscopia, Servicio de Aparato Digestivo, Hospital Universitari Doctor Josep Trueta, Girona, Catalunya, Spain.
Claudio NavarreteServicio de Endoscopía, Clínica Alemana de Santiago. Jefe de Departamento de Cirugia, Clinica Santa Maria, Santiago, Chile.
Marco J BrunoMaag-, Darm- en Leverziekten, Erasmus Universitair Medisch Centrum, Rotterdam, The Netherlands.
Paul P KortanDivision of Gastroenterology, Centre for Therapeutic Endoscopy and Endoscopic Oncology, St. Michael's Hospital, Toronto, Ontario, Canada.
Sundeep LakhtakiaService de Gastroentérologie et d'Endoscopie Digestive, Hôpital Edouard Herriot, Lyon, France.
Joyce PeetermansBoston Scientific Corporation, Marlboro, Massachusetts, United States.
Matthew RousseauBoston Scientific Corporation, Marlboro, Massachusetts, United States.
David Carr-LockeThe Center for Advanced Digestive Care, Weill Cornell Medicine, New York Presbyterian Hospital, New York, USA.
Jacques DevièreGastro-Entérologie et d'Hépato-Pancréatologie, Universite Libre de Bruxelles Hôpital Erasme, Brussels, Belgium.
Guido CostamagnaFondazione Policlinico Universitario A. Gemelli IRCCS, Digestive Endoscopy Unit, Rome, Italy.
Benign Biliary Stenoses Working Group
Università Cattolica del Sacro Cuore · ITBoston Scientific (United States) · USClínica Alemana · CLHôpital Edouard Herriot · FRSt. Michael's Hospital · CAAgostino Gemelli University Polyclinic · ITEvangelisches Krankenhaus Düsseldorf · DENewYork–Presbyterian Hospital · USUniversité Libre de Bruxelles · BE

Funding

Boston Scientific Corporation Not applicable
6 · The paper itself

Abstract

backgroundEndoscopic treatment of post-cholecystectomy biliary strictures (PCBS) with multiple plastic biliary stents placed sequentially is a minimally invasive alternative to surgery but requires multiple interventions. Temporary placement of a single fully-covered self-expanding metal stent (FCSEMS) may offer safe and effective treatment with fewer re-interventions. Long-term effectiveness of treatment with FCSEMS to obtain PCBS resolution has not yet been studied.

methodsIn this prospective multi-national study in patients with symptomatic benign biliary strictures (N = 187) due to various etiologies received a FCSEMS with scheduled removal at 6-12 months and were followed for 5 years. We report here long-term outcomes of the subgroup of patients with PCBS (N = 18). Kaplan Meier analyses assessed long-term freedom from re-stenting. Adverse events were documented.

resultsEndoscopic removal of the FCSEMS was achieved in 83.3% (15/18) of patients after median indwell of 10.9 (range 0.9-13.8) months. In the remaining 3 patients (16.7%), the FCSEMS spontaneously migrated and passed without complications. At the end of FCSEMS indwell, 72% (13/18) of patients had stricture resolution. At 5 years after FCSEMS removal, 84.6% (95% CI 65.0-100.0%) of patients who had stricture resolution at FCSEMS removal remained stent-free. In addition, at 75 months after FCSEMS placement, the probability of remaining stent-free was 61.1% (95% CI 38.6-83.6%) for all patients. Stent or removal related serious adverse events occurred in 38.9% (7/18) all resolved without sequalae.

conclusionsIn patients with symptomatic PCBS, temporary placement of a single FCSEMS intended for 10-12 months indwell is associated with long-term stricture resolution up to 5 years. Temporary placement of a single FCSEMS may be considered for patients with PCBS not involving the main hepatic confluence. TRIAL REGISTRATION NUMBERS: NCT01014390; CTRI/2012/12/003166; Registered 17 November 2009.

Indexed as

Self Expandable Metallic StentsCholangiopancreatography, Endoscopic RetrogradeCholecystectomyCholestasisConstriction, PathologicDevice RemovalFemaleFollow-Up StudiesHumansKaplan-Meier EstimateMaleMiddle AgedPostoperative ComplicationsProspective StudiesTime FactorsTreatment OutcomeBenign biliary strictureCholecystectomyV fully-covered self-expanding metal stents

Identifiers

PMID31830897
PMCPMC6909597
OpenAlexW2995905549

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.