Evidence map›Paper›PMID 39971830›Full record

Observational studyDigestive diseases and sciences2025

Uncovered Self-Expandable Metallic Stent with an Ultra-Thin Delivery Sheath in Unresectable Malignant Hilar Biliary Obstruction: A Multicenter Prospective Observational Study.

Kotaro Takeshita, Susumu Hijioka, Kenji Ikezawa, Takeshi Ogura, Masaki Kuwatani, Nao Fujimori, Shinpei Doi, Masato Endo, Saburo Matsubara, Reiko Yamada and 11 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Digestive diseases and sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
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

21 authors.

Kotaro TakeshitaDepartment of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Susumu HijiokaDepartment of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan. shijioka@ncc.go.jp.
Kenji IkezawaDepartment of Hepatobiliary and Pancreatic Oncology, Osaka International Cancer Institution, Osaka, Japan.
Takeshi OguraEndoscopy Center, Osaka Medical and Pharmaceutical University Hospital, Osaka, Japan.
Masaki KuwataniDepartment of Gastroenterology and Hepatology, Hokkaido University Hospital, Hokkaido, Japan.
Nao FujimoriDepartment of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Shinpei DoiDepartment of Gastroenterology, Teikyo University Mizonoguchi Hospital, Kanagawa, Japan.
Masato EndoDepartment of Gastroenterology, University of Tsukuba Hospital, Ibaragi, Japan.
Saburo MatsubaraDepartment of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
Reiko YamadaDepartment of Gastroenterology and Hepatology, Mie University Hospital, Mie, Japan.
Hirosato MashimaDepartment of Gastroenterology, Jichi Medical University Saitama Medical Center, Saitama, Japan.
Mikinori KataokaDepartment of Gastroenterology, Mita Hospital, International University of Health and Welfare, Tokyo, Japan.
Ryoji TakadaDepartment of Hepatobiliary and Pancreatic Oncology, Osaka International Cancer Institution, Osaka, Japan.
Atsushi OkudaEndoscopy Center, Osaka Medical and Pharmaceutical University Hospital, Osaka, Japan.
Akihisa OhnoDepartment of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Nobuhiro KatsukuraDepartment of Gastroenterology, Teikyo University Mizonoguchi Hospital, Kanagawa, Japan.
Hirosumi SuzukiDepartment of Gastroenterology, University of Tsukuba Hospital, Ibaragi, Japan.
Takamitsu TanakaDepartment of Gastroenterology and Hepatology, Mie University Hospital, Mie, Japan.
Masanari SekineDepartment of Gastroenterology, Jichi Medical University Saitama Medical Center, Saitama, Japan.
Hidetoshi KitamuraDepartment of Gastroenterology, Mita Hospital, International University of Health and Welfare, Tokyo, Japan.
Takuji OkusakaDepartment of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.

Funding

The National Cancer Center Research and Development Fund 2022-A-16
6 · The paper itself

Abstract

backgroundAlthough various self-expandable metallic stents (SEMSs) for malignant hilar biliary obstruction (MHBO) have been introduced, the optimal SEMS for MHBO has not yet been established. PURPOSE: This study aimed to evaluate outcomes of the transpapillary placement of an uncovered laser-cut SEMS with an ultra-thin delivery sheath (YABUSAME) for MHBO.

methodsThis multicenter, prospective study was conducted in 11 hospitals for 10 months (from March 2022 to December 2022). The primary outcome was the stent patency rate at 6 months. Key secondary outcomes were the technical success rate, clinical success rate, time to recurrent biliary obstruction (RBO), overall survival (OS), and adverse events.

resultsOf 45 enrolled patients, 43 patients underwent biliary drainage, including 42 patients who underwent YABUSAME placement; 66.7% of patients received chemotherapy, and 60% had previously undergone biliary drainage. Drainage methods were partial stent-in-stent, side-by-side, and unilateral in 65.1%, 7.0%, and 27.9% of patients, respectively. Technical and clinical success rates were 93.2% (41/45) and 79.1% (34/45), respectively. The incidence rate of early postprocedural adverse events was 2.2%. The stent patency rate at 6 months was 55.3%. The median time to RBO was 231 days. The median OS was 125 days.

conclusionThis study showed that the primary outcome, the 6-month stent patency rate, exceeded the expected rate of 55%, which indicates the efficacy of YABUSAME placement for MHBO.

Indexed as

Bile Duct NeoplasmsCholestasisSelf Expandable Metallic StentsAgedAged, 80 and overDrainageFemaleHumansMaleMiddle AgedProspective StudiesTreatment OutcomeDrainageEndoscopic retrograde cholangiopancreatographyHilar biliary obstructionMalignancyMetallic stent

Identifiers

PMID39971830
PMCPMC11972213

What OpenQuestion holds

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LicenceCC BY-NC
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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.