Evidence map›Paper›PMID 24379581›Full record

Trial reportWorld journal of gastroenterology2013

Randomized trial in malignant biliary obstruction: plastic vs partially covered metal stents.

Peter L Moses, Khalid M Alnaamani, Alan N Barkun, Stuart R Gordon, Roger D Mitty, M Stanley Branch, Thomas E Kowalski, Myriam Martel, Viviane Adam

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in World journal of gastroenterology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  16. Survival, stent patency, and cost-effectiveness of plastic biliary stentJGH open : an open access journal of gastroenterology and hepatology · 2021
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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

9 authors.

Peter L MosesPeter L Moses, Division of Gastroenterology and Hepatology, University of Vermont, Burlington, VT 05401, United States.
Khalid M AlnaamaniPeter L Moses, Division of Gastroenterology and Hepatology, University of Vermont, Burlington, VT 05401, United States.
Alan N BarkunPeter L Moses, Division of Gastroenterology and Hepatology, University of Vermont, Burlington, VT 05401, United States.
Stuart R GordonPeter L Moses, Division of Gastroenterology and Hepatology, University of Vermont, Burlington, VT 05401, United States.
Roger D MittyPeter L Moses, Division of Gastroenterology and Hepatology, University of Vermont, Burlington, VT 05401, United States.
M Stanley BranchPeter L Moses, Division of Gastroenterology and Hepatology, University of Vermont, Burlington, VT 05401, United States.
Thomas E KowalskiPeter L Moses, Division of Gastroenterology and Hepatology, University of Vermont, Burlington, VT 05401, United States.
Myriam MartelPeter L Moses, Division of Gastroenterology and Hepatology, University of Vermont, Burlington, VT 05401, United States.
Viviane AdamPeter L Moses, Division of Gastroenterology and Hepatology, University of Vermont, Burlington, VT 05401, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo compare efficacy and complications of partially covered self-expandable metal stent (pcSEMS) to plastic stent (PS) in patients treated for malignant, infrahilar biliary obstruction.

methodsMulticenter prospective randomized clinical trial with treatment allocation to a pcWallstent(®) (SEMS) or a 10 French PS. Palliative patients aged ≥ 18, for infrahilar malignant biliary obstruction and a Karnofsky performance scale index > 60% from 6 participating North American university centers. Primary endpoint was time to stent failure, with secondary outcomes of death, adverse events, Karnofsky performance score and short-form-36 scale administered on a three-monthly basis for up to 2 years. Survival analyses were performed for stent failure and death, with Cox proportional hazards regression models to determine significant predictive characteristics.

resultsEighty-five patients were accrued over 37 mo, 42 were randomized to the SEMS group and 83 patients were available for analyses. Time to stent failure was 385.3 ± 52.5 d in the SEMS and 153.3 ± 19.8 d in the PS group, P = 0.006. Time to death did not differ between groups (192.3 ± 23.4 d for SEMS vs 211.5 ± 28.0 d for PS, P = 0.70). The only significant predictor was treatment allocation, relating to the time to stent failure (P = 0.01). Amongst other measured outcomes, only cholangitis differed, being more common in the PS group (4.9% vs 24.5%, P = 0.029). The small number of patients in follow-up limits longitudinal assessments of performance and quality of life. From an initially planned 120 patients, only 85 patients were recruited.

conclusionPartially covered SEMS result in a longer duration till stent failure without increased complication rates, yet without accompanying measurable benefits in survival, performance, or quality of life.

Indexed as

MetalsStentsAcademic Medical CentersAgedAged, 80 and overChi-Square DistributionCholestasisDrainageFemaleHumansKaplan-Meier EstimateKarnofsky Performance StatusMaleMiddle AgedNeoplasmsNorth AmericaMetalsBiliaryCommon bile ductMetalObstructionPalliativePlasticRandomizedStent

Identifiers

PMID24379581
PMCPMC3870509

What OpenQuestion holds

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Registered trials

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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.