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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035293
Receipt No. 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 2018/12/17

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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
Email 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
Email kenken_mjp@yahoo.co.jp

Sponsor
Institute Division of Gastroenterology and Hepatology, Niigata university medical and dental hospital
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2016 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2018 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040202

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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