Evidence map›Paper›PMID 32036515›Full record

ArticleDigestive diseases and sciences2020

Utility and Safety of a Novel Fully Covered Metal Stent in Unresectable Distal Malignant Biliary Obstruction.

Kentaro Yamao, Mamoru Takenaka, Takeshi Ogura, Hiroaki Hashimoto, Hisakazu Matsumoto, Masashi Yamamoto, Tsukasa Ikeura, Akira Kurita, Zhao Liang Li, Hideyuki Shiomi and 3 more

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in Digestive diseases and sciences, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06453590 (Palliative Treatment of Distal Malignant Biliary Obstruction by Endoscopic Stents), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 25% 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.

NCT06453590 naactive not recruitingnot on this map

Palliative Treatment of Distal Malignant Biliary Obstruction by Endoscopic Stents: Uncovered, Partially Covered, or Fully Covered Metal Stents: A Prospective Randomized Multicenter Study

TypeinterventionalSponsorRegion StockholmRan2020 to 2027Enrolled450ConditionsPancreatic Cancer Non-resectable, Bile Duct Cancer, Papillary Carcinoma, Duodenal CancerArmsRandomization to uncovered SEMS treating jaundice due to distal malignant biliary obstruction., Randomization to partially covered SEMS treating jaundice due to distal malignant biliary obstruction., Randomization to fully covered SEMS treating jaundice due to distal malignant biliary obstruction.
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

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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

13 authors at 11 institutions in 1 country.

Kentaro YamaoDepartment of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, 589-8511, Japan. yamaken_volvo@yahoo.co.jp.ORCID 0000-0003-2497-7740
Mamoru TakenakaDepartment of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, 589-8511, Japan.
Takeshi OguraThe Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Osaka, 569-8686, Japan.
Hiroaki HashimotoDepartment of Gastroenterology, Bell Land General Hospital, Sakai, Osaka, 599-8247, Japan.
Hisakazu MatsumotoDepartment of Gastroenterology, Japanese Red Cross Wakayama Medical Center, Wakayama, 640-8558, Japan.
Masashi YamamotoDepartment of Gastroenterology, Toyonaka Municipal Hospital, Toyonaka, Osaka, 560-8565, Japan.
Tsukasa IkeuraThe Third Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka, 573-1191, Japan.
Akira KuritaDigestive Disease Center, Kitano Hospital, Osaka, 530-8480, Japan.
Zhao Liang LiDepartment of Gastroenterology, Takarazuka City Hospital, Takarazuka, Osaka, 665-0827, Japan.
Hideyuki ShiomiDivision of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Hyogo, 650-0017, Japan.
Yasutaka ChibaClinical Research Center, Kindai University Hospital, Osaka-Sayama, Osaka, 589-8511, Japan.
Masatoshi KudoDepartment of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, 589-8511, Japan.
Tsuyoshi SanukiDepartment of Gastroenterology, Kita-Harima Medical Center, Ono, Hyogo, 675-1392, Japan.
Kindai University · JPBerurando General Hospital · JPJapanese Red Cross Society Wakayama Medical Center · JPKansai Medical University · JPKindai University Hospital · JPKitano Hospital · JPKobe University · JPOsaka Medical and Pharmaceutical University · JPTakarazuka City Hospital · JPTokyo-Kita Medical Center · JPToyonaka Municipal Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSelf-expandable metal stents (SEMSs) are widely used in patients with distal malignant biliary obstruction. A SEMS that can avoid occlusion as much as possible is desirable.

aimsThe aim of this multicenter single-arm prospective study was to assess the clinical effectiveness and safety of a novel fully covered braided SEMS.

methodsWe enrolled consecutive patients with distal malignant biliary obstruction between February 2016 and November 2017 at ten tertiary-care medical centers.

resultsWe included 79 patients with a median age of 76 years; 47 (59.5%) patients were men. The technical and clinical success rate was 98.7% and 93.6%, respectively. Recurrent biliary obstruction occurred in 14 patients (17.9%); stent ingrowth, overgrowth, migration, and other occurred in five (6.4%), four (5.1%), four (5.1%), and one (1.3%) patients, respectively. All reinterventions in patients with recurrent biliary obstruction were successful via the transpapillary approach. Adverse events occurred in 15 patients (19.2%); cholangitis, pancreatitis, and others occurred in ten (12.8%), three (3.8%), and two (2.6%) patients, respectively. The stent patency probability at 6 months was 48.5%. Median time to stent patency was 171 days, median time to recurrent biliary obstruction was 536 days, and median survival time was 195 days.

conclusionsWe confirmed the utility and safety of a novel fully covered braided SEMS with low axial force and high radial force in patients with malignance biliary obstruction. This novel SEMS is recommended in patients with distal malignant biliary obstruction.

Indexed as

Bile Duct NeoplasmsCholangitisCholestasisDecompression, SurgicalPancreatitisPostoperative ComplicationsAgedEquipment Failure AnalysisFemaleHumansJapanMaleOutcome and Process Assessment, Health CareProsthesis FailureRecurrenceSelf Expandable Metallic StentsBile duct obstructionBiliary surgical procedureMalignancyObstructive jaundiceRecurrenceSelf-expandable metal stents

Identifiers

PMID32036515
OpenAlexW3005278030

What OpenQuestion holds

Textmetadata
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.