UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035293 |
|---|---|
| Receipt number | R000040202 |
| Scientific Title | Effectiveness and safety of endoscopic submucosal dissection for ulcerative colitis associated neoplasia |
| Date of disclosure of the study information | 2018/12/20 |
| Last modified on | 2022/06/29 09:03:29 |
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Basic information
Public title
Effectiveness and safety of endoscopic submucosal dissection for ulcerative colitis associated neoplasia
Acronym
ESD for UC associated neoplasia
Scientific Title
Effectiveness and safety of endoscopic submucosal dissection for ulcerative colitis associated neoplasia
Scientific Title:Acronym
ESD for UC associated neoplasia
Region
| Japan |
Condition
Condition
Ulcerative colitis associated neoplasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness and safety of ESD for ulcerative colitis associated neoplasia as the method of obtaining tissue specimen
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effectiveness of pathological diagnosis of ESD specimen comparing to forceps biopsy.
Key secondary outcomes
Safety(intra-prcedual perforation, delayed perforation, post-procedural bleeding),
Efficacy(operation duration, ratio ofcomplete resection and local recurrence)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patient who has the history of ulcerative colitis was enrolled in this study.
2)Patient has Intra-mucosal neoplasia
3)Distant metastasis and lymph node metastasis were excluded by CT or ultrasonography
4)Identifiable demrcation confirmed by pathological diagnosis of specimens taken from adjacent mucosa to the lesion
5)Remission or mild active UC (Mayo Endoscopic scoring 0-1)
6)Patient who has better understanding and regarded as suitable for this study
Key exclusion criteria
Patient regarded as unsuitable for this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Mizuno |
Organization
Graduate School of Medical and Dental Sciences, Niigata University
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
757-1, Asahimachidori, Chuo-ku, NIigata-city, Niigata 9518510, Japan
TEL
0252272207
kenken_mjp@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Mizuno |
Organization
Graduate School of Medical and Dental Sciences, Niigata University
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
757-1, Asahimachidori, Chuo-ku, NIigata-city, Niigata 9518510, Japan
TEL
0252272207
Homepage URL
kenken_mjp@yahoo.co.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Niigata university medical and dental hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2018 | Year | 12 | Month | 20 | 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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 09 | Month | 30 | Day |
Other
Other related information
We continue to observe the patients and investigate the recurrence of neoplasia.
Management information
Registered date
| 2018 | Year | 12 | Month | 17 | Day |
Last modified on
| 2022 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040202
