UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048310 |
|---|---|
| Receipt number | R000055053 |
| Scientific Title | Immediate Necrosectomy vs. Step-up Approach After EUS-guided Drainage of Walled-off Necrosis: a Multicenter Randomized Controlled Trial (WONDER-01) |
| Date of disclosure of the study information | 2022/07/07 |
| Last modified on | 2023/12/24 11:20:36 |
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Basic information
Public title
Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis: a Randomized Trial (WONDER-01)
Acronym
WONDER-01 study
Scientific Title
Immediate Necrosectomy vs. Step-up Approach After EUS-guided Drainage of Walled-off Necrosis: a Multicenter Randomized Controlled Trial (WONDER-01)
Scientific Title:Acronym
WONDER-01 study
Region
| Japan |
Condition
Condition
Walled-off necrosis
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Infectious disease |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of immediate endoscopic necrosectomy (EN) following endoscopic ultrasonography (EUS)-guided drainage compared to the step-up treatment in patients with symptomatic walled-off necrosis (WON).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to clinical success from randomization
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
-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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
[Immediate necrosectomy group]
Endoscopic necrosectomy will be conducted in the same session of EUS-guided drainage (or at least within 72 hours of randomization) and be repeated until clinical success.
Interventions/Control_2
[Step-up approach group]
Step-up treatment will be conducted if a patient's condition does not improve after EUS-guided drainage. The step-up approach includes increasing the number of stents, adding another EUS-guided drainage, and performing percutaneous drainage after 72-96 hours of the initial drainage. Endoscopic necrosectomy is considered when clinical improvement is not observed even after two times of step-up treatment.
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 WON defined according to the revised Atlanta classification
-The longest diameter of WON is 4 cm or larger
-Patients with at least one out of the following conditions; signs of infection, gastrointestinal symptoms, abdominal symptoms, obstructive jaundice
-Patients who need drainage for WON
-Age of 18 years or older
-Patients or their representatives provide informed consent
-Patients who visit or are hospitalized at the participating institutions
Key exclusion criteria
-WON inaccessible by EUS-guided approach
-AXIOS stent has already been placed into the WON prior to the enrollment
-Severe coagulopathy; Platelet count < 50,000/mm3 or prothrombin time international normalized ratio (PT-INR) >1.5
-Patients on antithrombotic agents which cannot be managed according to the "guideline for gastroenterological endoscopy in patients undergoing antithrombotic treatment (Dig Endosc. 2014 Jan;26(1):1-14.)"
-Patients who cannot tolerate endoscopic procedures
-Pregnant women
-Patients considered inappropriate for inclusion by investigators
Target sample size
70
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
Graduate School of Medicine, 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
2021005P
Org. issuing International ID_1
Research Ethics Committee, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Study ID_2
jRCT1032220055
Org. issuing International ID_2
jRCT
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)、友愛医療センター(沖縄県)、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）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2031 | Year | 04 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 07 | Day |
Last modified on
| 2023 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055053
