Evidence map›Paper›PMID 36208796›Full record

ArticleGastrointestinal endoscopy2023

Soft self-expandable metal stent to treat painful pancreatic duct strictures secondary to chronic pancreatitis: a prospective multicenter trial.

Stuart Sherman, Richard A Kozarek, Guido Costamagna, D Nageshwar Reddy, Paul Tarnasky, Raj J Shah, Adam Slivka, Evan Fogel, James Watkins, Myriam Delhaye and 9 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Gastrointestinal endoscopy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02802020 (Fully Covered Self Expanding Metal Stents), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
4.6field-weighted citation impact, top 4% 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.

NCT02802020 nacompletednot on this map

Fully Covered Self Expanding Metal Stents (FCSEMS) for Pancreatic Duct Strictures in Patients With Chronic Pancreatitis

TypeinterventionalSponsorBoston Scientific CorporationRan2017 to 2021Enrolled67ConditionsChronic PancreatitisArmsPancreatic fully-covered self-expanding metal stent (FCSEMS)
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 21 citations in OpenAlex.

  1. Chronic Pancreatitis: Role of Endoscopic Procedures.Digestive diseases and sciences · 2026
    Review
  2. Article
  3. Article
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  9. Biliary and pancreatic stents.iGIE : innovation, investigation and insights · 2023
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 10 institutions in 4 countries.

Stuart ShermanDivision of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Richard A KozarekDepartment of Gastroenterology, Digestive Disease Institute, Virginia Mason Medical Center, Seattle, Washington, USA.
Guido CostamagnaFondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
D Nageshwar ReddyAsian Institute of Gastroenterology, Hyderabad, India.
Paul TarnaskyDivision of Gastroenterology, Methodist Dallas Medical Center, Dallas, Texas, USA.
Raj J ShahDivision of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Adam SlivkaDepartment of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Evan FogelDivision of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, Indiana, USA.
James WatkinsDivision of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Myriam DelhayeDepartment of Gastroenterology, Hôpital Erasme, Brussels, Belgium.
Shayan S IraniDepartment of Gastroenterology, Digestive Disease Institute, Virginia Mason Medical Center, Seattle, Washington, USA.
Andrea TringaliFondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
Sundeep LakhtakiaAsian Institute of Gastroenterology, Hyderabad, India.
Prashant KediaDivision of Gastroenterology, Methodist Dallas Medical Center, Dallas, Texas, USA.
Steven EdmundowiczDivision of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Joyce A PeetermansEndoscopy Division, Boston Scientific Corporation, Marlborough, Massachusetts, USA.
Matthew J RousseauEndoscopy Division, Boston Scientific Corporation, Marlborough, Massachusetts, USA.
Jacques DevièreDepartment of Gastroenterology, Hôpital Erasme, Brussels, Belgium.
Pancreatic SEMS in Chronic Pancreatitis Study Group
Agostino Gemelli University Polyclinic · ITAsian Institute of Gastroenterology · INBoston Scientific (United States) · USErasmus Hospital · BEIndiana University School of MedicineMethodist Dallas Medical Center · USUniversity of Colorado Anschutz Medical Campus · USVirginia Mason Medical Center · USIndiana University – Purdue University Indianapolis · USUniversity of Pittsburgh Medical Center · US

Funding

Indiana University (IU) Clinical Center for Chronic Pancreatitis Clinical Research NetworkU01DK108323 · NIDDK · INDIANA UNIVERSITY INDIANAPOLIS · PI Jeffrey James Easler, Evan L Fogel · 2015 to 2026
$6.5M
NIDDK NIH HHS U01 DK108323
6 · The paper itself

Abstract

BACKGROUND AND

aimsFully covered self-expandable metal stents (FCSEMSs) may offer a treatment option for pain associated with a dilated pancreatic duct (PD) in chronic pancreatitis (CP), but optimal patient selection and FCSEMS design, efficacy, and safety remain uncertain. We studied an investigational pancreatic FCSEMS for treatment of CP-associated pain.

methodsPatients with painful CP, a dominant distal PD stricture, and PD dilation upstream were enrolled in a prospective, multicenter, single-arm trial studying 6-month indwell of a 4- to 6-cm-long soft pancreatic FCSEMS. Primary efficacy and safety endpoints were pain reduction 6 months after FCSEMS indwell (performance goal ≥53%) and PD stenting-related serious adverse events (SAEs), respectively (performance goal <32%). The primary efficacy endpoint was assessed in patients with sufficiently severe and frequent pain at FCSEMS placement as a first stent or in exchange of a plastic stent.

resultsAmong 67 patients (mean age, 52.7 ± 12.5 years; mean time since CP diagnosis, 6.4 ± 6.4 years), 34 (50.7%) had plastic stent placement within 90 days of FCSEMS placement, and 46 patients were eligible for the primary efficacy endpoint analysis. Technical success was 97.0% (65/67). The observed primary efficacy (26.1%, 12/46) and safety endpoints (31.3%, 21/67) failed to meet the a priori study hypotheses. Study stent migration occurred in 47.7% of patients (31/65).

conclusionsSix-month treatment with an FCSEMS did not lead to an expected degree of pain reduction, and migrations and SAEs were common. Further study is needed to clarify optimal decompressive strategy, FCSEMS design, and patient selection. (Clinical trial registration number: NCT02802020.).

Indexed as

Gastrointestinal DiseasesPancreatitis, ChronicSelf Expandable Metallic StentsAdultAgedCholangiopancreatography, Endoscopic RetrogradeConstriction, PathologicHumansMiddle AgedPainPancreatic DuctsPlasticsProspective StudiesStentsTreatment OutcomePlastics

Identifiers

PMID36208796
PMCPMC10122209
OpenAlexW4302024788

What OpenQuestion holds

Textmetadata
LicenceTDM
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.