Evidence map›Paper›PMID 37169945›Full record

Trial reportScientific reports2023

Efficacy of a newly developed guidewire for selective biliary access.

Do Hyun Park, Joung-Ho Han, Tae Hoon Lee, Jae Kook Yang, Ji Sung Lee, Yong Hun Lee, Mamoru Takenaka, Sang-Heum Park

Open access · goldAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Scientific reports, 2023. 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
1.3field-weighted citation impact, top 19% 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.

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, 5 citations in OpenAlex.

  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

8 authors at 5 institutions in 2 countries.

Do Hyun Park *Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Joung-Ho Han *Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea.
Tae Hoon LeeDepartment of Internal Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, 31, Sooncheonhyang 6-gil, Dongnam-gu, Cheonan, Chungcheongnam-do, 31151, South Korea. thlee9@schmc.ac.kr.
Jae Kook YangDepartment of Internal Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, 31, Sooncheonhyang 6-gil, Dongnam-gu, Cheonan, Chungcheongnam-do, 31151, South Korea.
Ji Sung LeeClinical Research Center, Asan Institute for Life Sciences, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Yong Hun LeeResearch and Development, Sungwon Medical Co., Ltd., Cheongju, South Korea.
Mamoru TakenakaDepartment of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osaka, Japan.
Sang-Heum ParkDepartment of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Asan Medical Center · KRSoonchunhyang University · KRChungbuk National University Hospital · KRKindai University · JPUlsan College · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A clinical efficacy study of 0.025-inch guidewires (GWs) according to mechanical property analysis has not been reported yet. This study was designed to evaluate the clinical efficacy of a newly developed 0.025-inch GW for biliary access according to the basic mechanical property. Commercially available 0.025-inch GWs were in vitro tested based on parameters of mechanical property. Patients with naïve papilla requiring diagnostic or therapeutic ERCP were randomly assigned to an experimental 0.025-inch newly developed GW or a control 0.025-inch GW group. Technical success rate of wire-guided cannulation (WGC), difficult biliary cannulation (DBC), and adverse event rates were measured in this multicenter randomized trial. The technical success rate of primary WGC was 79.1% (151 of 191) in the experimental group and 70.8% (131 of 185) in the control group (95% two-sided confidence interval: 8.25%; p < 0.001; for a noninferiority margin of 15%). The technical success rate including cross-over to each other was also non-inferior. However, the chi-square test showed a statistical difference (81.7% vs. 68.1%; p = 0.002). Median biliary cannulation time was shorter in the experimental group (53 s vs. 77 s; p = 0.047). The rate of DBC was more frequent in the control group (34.6% vs. 50.3% p = 0.002). Multivariate analysis revealed that control group was one of contributing factors for DBC. Overall rate of post-ERCP pancreatitis was not different (4.7% vs. 8.6%; p = 0.125). WGC using a newly developed GW with superior physical performance GW in a bench test showed similar clinical efficacy and the rate of DBC was significantly lower in experimental GW.

Indexed as

Biliary TractPancreatitisCatheterizationCholangiopancreatography, Endoscopic RetrogradeHumansTreatment Outcome

Identifiers

PMID37169945
PMCPMC10175558
OpenAlexW4376225101

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.