UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036257 |
|---|---|
| Receipt number | R000041245 |
| Scientific Title | Efficacy and safety of water-pocket endoscopic submucosal dissection for supeficial duodenal epithelial neoplasia |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2019/07/03 08:54:21 |
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Basic information
Public title
Efficacy and safety of water-pocket endoscopic submucosal dissection for supeficial duodenal epithelial neoplasia
Acronym
Water-pocket endoscopic submucosal dissection for supeficial duodenal epithelial neoplasia
Scientific Title
Efficacy and safety of water-pocket endoscopic submucosal dissection for supeficial duodenal epithelial neoplasia
Scientific Title:Acronym
Water-pocket endoscopic submucosal dissection for supeficial duodenal epithelial neoplasia
Region
| Japan |
Condition
Condition
Patients who undergo endoscopic submucosal dissection for superficilal duodenal epithelial neoplasis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of water-pocket ESD for superficial duodenal neoplasia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
En bloc resection
Key secondary outcomes
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who will undergo duodenal ESD at our hospital and have given written informed consent to this sutdy.
Key exclusion criteria
Patients who have hematological abnormality and/or undergoing hemodialysis
Patients who have serious complications
Patients who are considered to be inappropriate for this study by doctors
Patients who have polypoid lesions and/or inflammatory bowel disease
Women who have baby and are pregnant
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Harada |
Organization
New Tokyo Hospital
Division name
Gastroenterology
Zip code
270-2232
Address
1271 Wanagaya
TEL
0081477118700
nerimaendo@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Hayasaka |
Organization
New Tokyo Hospital
Division name
Gastroenterology
Zip code
270-2232
Address
1271 Wanagaya
TEL
0081477118700
Homepage URL
nerimaendo@hotmail.co.jp
Sponsor or person
Institute
New Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
New Tokyo Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
New Tokyo Hospital
Address
1271 Wanagaya
Tel
0081477118700
nerimaendo@hotmail.co.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
| 2019 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
20 Patients who will undergo water-pocket ESD for superficila duodenal epithelial eoplasias to evaluate the en bloc resection rates compared to historical records.
Management information
Registered date
| 2019 | Year | 03 | Month | 19 | Day |
Last modified on
| 2019 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041245
