Evidence map›Paper›PMID 32993731›Full record

ArticleTrials2020

Comparison of endoscopic ultrasound-guided hepaticogastrostomy and the antegrade technique in the management of unresectable malignant biliary obstruction: study protocol for a prospective, multicentre, randomised controlled trial.

Ye Liao, Marc Giovannini, Ning Zhong, Tingyue Xiao, Shiyun Sheng, Yufan Wu, Jingjing Zhang, Sheng Wang, Xiang Liu, Siyu Sun and 1 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 46% 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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Endoscopic Ultrasound-Guided Biliary Drainage.Journal of clinical medicine · 2023
    Review
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 at 4 institutions in 2 countries.

Ye LiaoDepartment of gastroenterology, Shengjing Hospital of China Medical University, No. 36, Sanhao Street, Shenyang, 110004, China.
Marc GiovanniniEndoscopy Unit, Paoli Calmettes Institute, 232 bd Ste Marguerite, 13009, Marseille, France.
Ning ZhongDepartment of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, 250012, China.
Tingyue XiaoThe Sixth People's Hospital of Shenyang, Shenyang, 110006, China.
Shiyun ShengDepartment of gastroenterology, Shengjing Hospital of China Medical University, No. 36, Sanhao Street, Shenyang, 110004, China.
Yufan WuDepartment of gastroenterology, Shengjing Hospital of China Medical University, No. 36, Sanhao Street, Shenyang, 110004, China.
Jingjing ZhangDepartment of gastroenterology, Shengjing Hospital of China Medical University, No. 36, Sanhao Street, Shenyang, 110004, China.
Sheng WangDepartment of gastroenterology, Shengjing Hospital of China Medical University, No. 36, Sanhao Street, Shenyang, 110004, China.
Xiang LiuDepartment of gastroenterology, Shengjing Hospital of China Medical University, No. 36, Sanhao Street, Shenyang, 110004, China.
Siyu SunDepartment of gastroenterology, Shengjing Hospital of China Medical University, No. 36, Sanhao Street, Shenyang, 110004, China. sun-siyu@163.com.
Jintao GuoDepartment of gastroenterology, Shengjing Hospital of China Medical University, No. 36, Sanhao Street, Shenyang, 110004, China. guojt@sj-hospital.org.ORCID http://orcid.org/0000-0001-9026-8438
China Medical University · CNInstitut Paoli-Calmettes · FRQilu Hospital of Shandong University · CNThe Sixth People's Hospital of Shenyang · CN

Funding

National Natural Science Foundation of China 81900601Natural Science Foundation of Liaoning Province 207541024Shengjing Free Researcher Project Foundation 201702
6 · The paper itself

Abstract

backgroundEndoscopic ultrasound-guided biliary drainage (EUS-BD) is used after failed endoscopic retrograde cholangiopancreatography. Based on existing studies, intrahepatic (IH) approaches are preferred in patients with dilated IH bile ducts. Both ultrasound-guided hepaticogastrostomy (EUS-HGS) and ultrasound-guided antegrade treatment (EUS-AG) are appropriate for patients with unreachable papillae. Nevertheless, there have been no direct comparisons between these two approaches. Therefore, we aim to evaluate and compare the safety and efficiency of EUS-HGS and EUS-AG in patients with an unreachable papilla.

methodsThis is a prospective, randomised, controlled, multicentre study with two parallel groups without masking. One hundred forty-eight patients from three hospitals who met the inclusion criteria will be randomly assigned (1:1) to undergo either EUS-HGS or EUS-AG for relief of malignant biliary obstruction. The final study follow-up is scheduled at 1 year postoperatively. The primary endpoint is efficiency, described by technical and clinical success rates of EUS-HGS and EUS-AG in patients with unreachable papillae. The secondary endpoints include stent patency, overall survival rates, complication rates, length of hospital stays, and hospitalisation expenses. The chi-square test, Kaplan-Meier methods, log-rank test, and Cox regression analysis will be used to analyse the data. DISCUSSION: To our knowledge, this is the first study to compare these two EUS-BD approaches directly using a multicentre, randomised, controlled trial design. The clinical economic indexes will also be compared, as they may also affect the patient's choice. The result may contribute to establishing a strategic guideline for choosing IH EUS-BD approaches.

trial registrationChinese Clinical Trial Registry (ChiCTR) ChiCTR1900020737 . Registered on 15 January 2019.

Indexed as

CholestasisDrainageEndosonographyHumansMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicStentsUltrasonography, InterventionalEUS-AGEUS-HGSIntrahepatic EUS-BDMalignant biliary obstructionRandomised controlled trial

Identifiers

PMID32993731
PMCPMC7525949
OpenAlexW3089880223

What OpenQuestion holds

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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.