UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060004 |
|---|---|
| Receipt number | R000068628 |
| Scientific Title | Evaluation of Drainage Methods After Endoscopic Submucosal Dissection Including the Papilla (ESDIP) for Papillary-Involving Duodenal Tumors |
| Date of disclosure of the study information | 2025/12/09 |
| Last modified on | 2025/12/07 14:49:16 |
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Basic information
Public title
Evaluation of Drainage Methods After Endoscopic Submucosal Dissection Including the Papilla (ESDIP) for Papillary-Involving Duodenal Tumors
Acronym
Evaluation of Drainage Methods After Endoscopic Submucosal Dissection Including the Papilla (ESDIP) for Papillary-Involving Duodenal Tumors
Scientific Title
Evaluation of Drainage Methods After Endoscopic Submucosal Dissection Including the Papilla (ESDIP) for Papillary-Involving Duodenal Tumors
Scientific Title:Acronym
Evaluation of Drainage Methods After Endoscopic Submucosal Dissection Including the Papilla (ESDIP) for Papillary-Involving Duodenal Tumors
Region
| Japan |
Condition
Condition
deuodenal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of gel-assisted drainage during cannulation after endoscopic submucosal dissection (ESD) for duodenal tumors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Procedure time to achieve successful cannulation
Key secondary outcomes
Bleeding, Perforation, Pancreatitis, Total procedure time. Rate of hemoglobin decrease>2 g/dL, Blood transfusion
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients undergoing biliary and pancreatic duct cannulation for drainage after ESDIP for duodenal adenoma
2.Patients aged >19 and <100 years at the time of consent
3.Patients who provide written informed consent to participate in this study
Key exclusion criteria
1.Patients with invasive cancer who are eligible for surgical treatment
2.Cases in which the attending physician judges participation in this study to be inappropriate
3.Patients who withdraw their consent and refuse participation after enrollment
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Kawasaki |
Organization
Keio University School of Medicine
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL
03-3353-1211
s.kawasaki@keio.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Kawasaki |
Organization
Keio University School of Medicine
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL
03-3353-1211
Homepage URL
s.kawasaki@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
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, Keio University School of Medicine
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
Tel
03-3353-1211
s.kawasaki@keio.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
| 2025 | Year | 12 | Month | 09 | 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
| 2025 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2025 | Year | 12 | Month | 07 | Day |
Last modified on
| 2025 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068628
