Evidence map›Paper›PMID 31148908›Full record

Trial reportWorld journal of gastroenterology2019

New antireflux plastic stent for patients with distal malignant biliary obstruction.

Xiang-Lei Yuan, Bin Wei, Lian-Song Ye, Chun-Cheng Wu, Qing-Hua Tan, Ming-Hong Yao, Yu-Hang Zhang, Xian-Hui Zeng, Yan Li, Yu-Yan Zhang and 1 more

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in World journal of gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. 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

11 authors.

Xiang-Lei YuanDepartment of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China.
Bin WeiDepartment of Gastroenterology, the First Hospital of Xi'an City, Xi'an 710002, Shaanxi Province, China.
Lian-Song YeDepartment of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China.
Chun-Cheng WuDepartment of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China.
Qing-Hua TanDepartment of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China.
Ming-Hong YaoDepartment of Epidemiology and Health Statistics, West China School of Public Health, Sichuan University, Chengdu 610041, Sichuan Province, China.
Yu-Hang ZhangDepartment of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China.
Xian-Hui ZengDepartment of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China.
Yan LiDepartment of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China.
Yu-Yan ZhangDepartment of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China.
Bing HuDepartment of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China. hubingnj@163.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEndoscopic biliary stenting is a well-established palliative treatment for patients with unresectable distal malignant biliary obstruction (MBO). However, the main problem with stent placement is the relatively short duration of stent patency. Although self-expanding metal stents (SEMSs) have a longer patency period than plastic stents (PSs), the higher costs limit the wide use of SEMSs. A PS with an antireflux valve is an attractive idea to prolong stent patency, but no ideal design for an antireflux PS (ARPS) has been proposed. We developed a new ARPS with a "duckbilled" valve attached to the duodenal end of the stent.

aimTo compare the patency of ARPSs with that of traditional PSs (TPSs) in patients with unresectable distal MBO.

methodsWe conducted a single-center, prospective, randomized, controlled, double-blind study. This study was conducted at the West China Hospital of Sichuan University. Consecutive patients with extrahepatic MBO were enrolled prospectively. Eligible patients were randomly assigned to receive either an ARPS or a TPS. Patients were followed by clinic visits or telephone interviews every 1-2 mo until stent exchange, death, or the final study follow-up in October 2018. The primary outcome was the duration of stent patency. Secondary outcomes included the rate of technical success, the rate of clinical success, adverse events, and patient survival.

resultsBetween February 2016 and December 2017, 38 patients were randomly assigned to two groups, with 19 patients in each group, to receive ARPSs or TPSs. Stent insertion was technically successful in all patients. There were no significant differences between the two groups in the rates of clinical success or the rates of early or late adverse events (

conclusionThe new ARPS is safe and effective for the palliation of unresectable distal MBO, and has a significantly longer stent patency than a TPS.

Indexed as

Prosthesis DesignAgedAged, 80 and overBile RefluxCholangiopancreatography, Endoscopic RetrogradeCholestasis, ExtrahepaticDouble-Blind MethodFemaleHumansMaleMiddle AgedNeoplasmsPalliative CarePlasticsProspective StudiesProsthesis FailurePlasticsAntireflux valveDistal malignant biliary obstructionEndoscopic retrograde cholangiopancreatographyPlastic biliary stentStent patency

Identifiers

PMID31148908
PMCPMC6529883

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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.