UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040202