Evidence map›Paper›PMID 39182137›Full record

ArticleTrials2024

WONDER-02: plastic stent vs. lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic pseudocysts-study protocol for a multicentre randomised non-inferiority trial.

Tomotaka Saito, Mamoru Takenaka, Masaki Kuwatani, Shinpei Doi, Hiroshi Ohyama, Toshio Fujisawa, Atsuhiro Masuda, Takuji Iwashita, Hideyuki Shiomi, Nobuhiko Hayashi and 22 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06133023 (WONDER-02), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT06133023 nanot yet recruitingnot on this map

WONDER-02: Plastic Stent vs. Lumen-apposing Metal Stent for Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts-a Multicentre Randomised Non-inferiority Trial

TypeinterventionalSponsorTokyo UniversityRan2023 to 2033Enrolled80ConditionsPancreatic Fluid Collection, Pancreatitis, Pancreatic PseudocystArmsPlastic stent, LAMS
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

32 authors.

Tomotaka Saito *Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.ORCID http://orcid.org/0000-0001-6008-1648
Mamoru Takenaka *Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osaka, Japan.
Masaki Kuwatani *Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Hokkaido, Japan.
Shinpei DoiDepartment of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa, Japan.
Hiroshi OhyamaDepartment of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba, Japan.
Toshio FujisawaDepartment of Gastroenterology, Graduate School of Medicine, Juntendo University, Tokyo, Japan.
Atsuhiro MasudaDivision of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Hyogo, Japan.
Takuji IwashitaFirst Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.
Hideyuki ShiomiDivision of Hepatobiliary and Pancreatic Diseases, Department of Gastroenterology, Hyogo Medical University, Hyogo, Japan.
Nobuhiko HayashiThird Department of Internal Medicine, University of Toyama, Toyama, Japan.
Keisuke IwataDepartment of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan.
Akinori MarutaDepartment of Gastroenterology, Gifu Prefectural General Medical Center, Gifu, Japan.
Tsuyoshi MukaiDepartment of Gastroenterological Endoscopy, Kanazawa Medical University, Ishikawa, Japan.
Saburo MatsubaraDepartment of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
Tsuyoshi HamadaDepartment of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Tadahisa InoueDepartment of Gastroenterology, Aichi Medical University, Aichi, Japan.
Kazuyuki MatsumotoDepartment of Gastroenterology and Hepatology, Okayama University Hospital, Okayama, Japan.
Sumio HiroseDepartment of Gastroenterology, Yamanashi Prefectural Central Hospital, Yamanashi, Japan.
Nao FujimoriDepartment of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Kosuke KashiwabaraData Science Office, Clinical Research Promotion Center, The University of Tokyo Hospital, Tokyo, Japan.
Hideki KamadaDepartment of Gastroenterology and Neurology, Kagawa University, Kagawa, Japan.
Shinichi HashimotoDigestive and Life-Style Diseases, Kagoshima University Graduate School of Medicine and Dental Sciences, Kagoshima, Japan.
Toshiyasu ShiratoriDepartment of Gastroenterology, Kameda Medical Center, Chiba, Japan.
Reiko YamadaDepartment of Gastroenterology and Hepatology, Mie University Hospital, Mie, Japan.
Hirofumi KogureDivision of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.
Kazunari NakaharaDepartment of Gastroenterology, St. Marianna University School of Medicine, Kanagawa, Japan.
Takeshi OguraEndoscopy Center, Osaka Medical and Pharmaceutical University Hospital, Osaka, Japan.
Masayuki KitanoDepartment of Gastroenterology, Wakayama Medical University School of Medicine, Wakayama, Japan.
Ichiro Yasuda *Third Department of Internal Medicine, University of Toyama, Toyama, Japan.
Hiroyuki Isayama *Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Tokyo, Japan.
Yousuke Nakai *Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. ynakai-tky@umin.ac.jp.ORCID http://orcid.org/0000-0001-7411-1385
WONDERFUL study group in Japan and collaborators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEndoscopic ultrasound (EUS)-guided transluminal drainage has become a first-line treatment modality for symptomatic pancreatic pseudocysts. Despite the increasing popularity of lumen-apposing metal stents (LAMSs), plastic stents may resolve non-necrotic fluid collections effectively with lower costs and no LAMS-specific adverse events. To date, there has been a paucity of data on the appropriate stent type in this setting. This trial aims to assess the non-inferiority of plastic stents to a LAMS for the initial EUS-guided drainage of pseudocysts.

methodsThe WONDER-02 trial is a multicentre, open-label, non-inferiority, randomised controlled trial, which will enrol pancreatic pseudocyst patients requiring EUS-guided treatment in 26 centres in Japan. This trial plans to enrol 80 patients who will be randomised at a 1:1 ratio to receive either plastic stents or a LAMS (40 patients per arm). In the plastic stent group, EUS-guided drainage will be performed using two 7-Fr double pigtail stents. In the LAMS group, the treatment will be performed in the same way except for LAMS use. The step-up treatment will be performed via endoscopic and/or percutaneous procedures at the trial investigator's discretion. The primary endpoint is clinical success, which is defined as a decrease in a pseudocyst size to ≤ 2 cm and an improvement in inflammatory indicators (i.e. body temperature, white blood cell count, and serum C-reactive protein). Secondary endpoints include technical success, adverse events including mortality, pseudocyst recurrence, and medical costs. DISCUSSION: The WONDER-02 trial will investigate the efficacy and safety of plastic stents compared to a LAMS in EUS-guided treatment of symptomatic pancreatic pseudocysts with a particular focus on the non-inferior efficacy of plastic stents. The findings will help establish a new treatment algorithm for this population.

trial registrationClinicalTrials.gov NCT06133023 registered on 9 November 2023. UMIN000052647 registered on 30 October 2023. jRCT1032230444 registered on 7 November 2023.

Indexed as

DrainageEndosonographyMulticenter Studies as TopicPancreatic PseudocystPlasticsStentsAdultEquivalence Trials as TopicHumansJapanMaleMetalsTreatment OutcomeUltrasonography, InterventionalMetalsPlasticsDrainageEndoscopyEndosonographyMortalityPancreatic fistulaPancreatic pseudocystPancreatitisRandomised clinical trialSepsisStents

Identifiers

PMID39182137
PMCPMC11344301

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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.