UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052647 |
|---|---|
| Receipt number | R000060077 |
| Scientific Title | WONDER-02: plastic stent vs. lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic pseudocysts-a multicentre randomised non-inferiority trial |
| Date of disclosure of the study information | 2023/10/30 |
| Last modified on | 2023/10/30 10:13:06 |
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Basic information
Public title
WONDER-02: plastic stent vs. lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic pseudocysts-a multicentre randomised non-inferiority trial
Acronym
WONDER-02 trial
Scientific Title
WONDER-02: plastic stent vs. lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic pseudocysts-a multicentre randomised non-inferiority trial
Scientific Title:Acronym
WONDER-02 trial
Region
| Japan |
Condition
Condition
Pancreatic Pseudocyst
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Infectious disease |
| Hepato-biliary-pancreatic surgery | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This trial aims to assess the non-inferiority of plastic stents to a LAMS for the initial EUS-guided drainage of pseudocysts
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical success within 180 days of randomisation
Key secondary outcomes
-Adverse events
-Mortality
-Technical success rate of initial EUS-PCD (Endoscopic ultrasonography-guided pseudocyst drainage)
-Incidence of biliary and gastrointestinal stricture
-Number and time of interventions
-Indwelling time of endoscopic and percutaneous drainage
-Time to success
-Success rate and operation time of surgical procedures
-Hospital stay and ICU stay
-Duration of antibiotics administration
-Cost of interventions and hospital stay
-Recurrence of WON
-Time to recurrence of WON
-Treatment duration of recurrent WON
-New onset of pseudocyst
-Treatment duration of new-onset pseudocyst
-Incidence of new-onset diabetes, clinical symptoms of pancreatic exocrine insufficiency, and pancreatic cancer
-The presence and timing of medications for pancreatic exocrine insufficiency
-The presence and timing of sarcopenia
-Morphological change of pancreas
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The plastic stent group: Two (at least one) 7-Fr double pigtail stents will be placed. Following EUS guided puncture of a pseudocyst, a guidewire will be coiled within the lesion, and another guidewire will be inserted alongside the prepositioned guidewire. The puncture tract will be dilated if needed.
Interventions/Control_2
LAMS group: A LAMS with electrocautery enhanced delivery will be placed (Hot AXIOS; Boston Scientific Japan, Tokyo, Japan). A guidewire or dilator will be used if needed.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Patients with pancreatic pseudocyst defined by the revised Atlanta classification
-The longest diameter of a targeted pseudocyst is more than 5 cm
-Patients requiring drainage for symptoms associated with a pseudocyst
-Patients aged 18 years or older
-Written informed consent obtained from patients or their representatives
Key exclusion criteria
-A pseudocyst that is inaccessible via the EUS-guided approach
-A plastic or lumen-apposing metal stent in situ
-Coagulopathy (e.g., platelet count < 50,000/mm3 or prothrombin time
international normalised ratio [PT-INR] >1.5)
-Users of antithrombotic agents that cannot be discontinued according to
the Japan Gastroenterological Endoscopy Society [JGES] guidelines
-Patients who do not tolerate endoscopic procedures
-Pregnant women
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yousuke |
| Middle name | |
| Last name | Nakai |
Organization
The University of Tokyo Hospital
Division name
Department of Endoscopy and Endoscopic Surgery
Zip code
113-8655
Address
7-3-1, Hongo Bunkyo-ku, Tokyo, JAPAN 113-8655
TEL
03-3815-5411
ynakai-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tomotaka |
| Middle name | |
| Last name | Saito |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
113-8655
Address
7-3-1, Hongo Bunkyo-ku, Tokyo, JAPAN 113-8655
TEL
03-3815-5411
Homepage URL
tomsaito-gi@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1, Hongo Bunkyo-ku, Tokyo, Japan, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2023002P
Org. issuing International ID_1
Research Ethics Committee, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
富山大学病院(富山県)、順天堂大学医学部附属順天堂医院(東京都)、岐阜大学医学部附属病院(岐阜県)、兵庫医科大学病院(兵庫県)、近畿大学病院(大阪府)、神戸大学病院(兵庫県)、金沢医科大学病院(石川県)、岐阜県総合医療センター(岐阜県)、岐阜市民病院(岐阜県)、埼玉医科大学総合医療センター(埼玉県)、大阪医科薬科大学病院(大阪府)、帝京大学医学部附属溝口病院(神奈川県)、鹿児島大学病院(鹿児島県)、愛知医科大学(愛知県)、北海道大学病院(北海道)、香川大学病院(香川県)、千葉大学病院(千葉県)、亀田総合病院(千葉県)、日本大学医学部附属板橋病院(東京都)、三重大学医学部附属病院（三重県）、聖マリアンナ医科大学病院（神奈川県）、岡山大学病院（岡山県）、和歌山県立医科大学附属病院（和歌山県）、山梨県立中央病院（山梨県）、九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2033 | Year | 08 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 30 | Day |
Last modified on
| 2023 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060077
