UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051227 |
|---|---|
| Receipt number | R000058416 |
| Scientific Title | Safety and efficacy of hydrogen peroxide lavage during endoscopic treatments for walled-off necrosis |
| Date of disclosure of the study information | 2023/06/07 |
| Last modified on | 2023/06/01 21:00:20 |
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Basic information
Public title
A study of hydrogen peroxide for endoscopic management of pancreatic walled-off necrosis
Acronym
Hydrogen peroxide for walled-off necrosis
Scientific Title
Safety and efficacy of hydrogen peroxide lavage during endoscopic treatments for walled-off necrosis
Scientific Title:Acronym
Hydrogen peroxide for walled-off necrosis
Region
| Japan |
Condition
Condition
Pancreatic walled-off necrosis (WON)
Classification by specialty
| Hepato-biliary-pancreatic medicine | Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety and effectiveness of hydrogen peroxide for endoscopic management of pancreatic walled-off necrosis (WON)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Moderate or severe adverse events during the index hospitalization
Key secondary outcomes
1. Clinical success (defined as a WON reduction in size with relief of symptoms)
2. Time to clinical success (treatment period)
3. Length of stay
4. All adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lavage using hydrogen peroxide during endoscopic interventions for WON
Interventions/Control_2
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
1. Patients diagnosed with WON according to the Revised Atlanta classification (Banks PA et al. Gut 2013;62:102-11)
2. Patients with symptoms associated with WON (e.g., fever, abdominal pain, abdominal distention, GI obstruction, obstructive jaundice) requiring endoscopic drainage
Key exclusion criteria
1. Patients for whom endoscopic interventions are not suitable, including the following
1) Endoscopic or percutaneous approach to WON is not possible
2) Bleeding tendency (platelet count <50000/mm3 or PT-INR >1.5)
3) Antithrombotic agents cannot be discontinued according to the recommendations by the Japan Gastroenterological Endoscopy Society
4) Investigators consider that patients are not suitable for endoscopic or percutaneous treatment of WON
2. A history of severe allergic reactions (e.g., anaphylactic shock) to drugs
3. A history of an allergic reaction to hydrogen peroxide
4. Investigators consider that patients are not eligible for this study for any reasons
Target sample size
10
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 City, Tokyo
TEL
+81-3-3815-5411
ynakai-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tomotaka |
| Middle name | |
| Last name | Saito |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo City, Tokyo
TEL
+81-3-3815-5411
Homepage URL
tomsaito-gi@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
No outside funding source.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo Hospital
Address
7-3-1 Hongo, Bunkyo City, Tokyo
Tel
+81-3-3815-8743
CReSjimu-tokyo@umin.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | 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 | 06 | Month | 01 | Day |
Last modified on
| 2023 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058416
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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