UMIN-CTR Clinical Trial

Basic information
Public title	Magnifying endoscopic assessment for mucosal healing by leukocytoapheresis in ulcerative colitis patients
Acronym	Magnifying endoscopy, leukocytoapheresis and ulcerative colitis
Scientific Title	Magnifying endoscopic assessment for mucosal healing by leukocytoapheresis in ulcerative colitis patients
Scientific Title:Acronym	Magnifying endoscopy, leukocytoapheresis and ulcerative colitis
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess relationship between magifying endoscopic findings and prognosis of ulcerative colitis treated by LCAP
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate clinical course of ulcerative colitis with magnifying endoscopic findings change of mucosal healing before and after LCAP
Key secondary outcomes	remission period, endoscopic findings, and severity in ulcerative colitis

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	Ulcerative colitis patients treated by LCAP in whom informed consent was obtained to enroll in this study
Key exclusion criteria	severe concomitant diseases such as liver, kidney and heart diseases prengnant or lactating cases patients prescribed with ACE inhibitors unsuitable patients judged by responsible persons
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hajime Middle name Last name Isomoto
Organization	Nagasaki University Hospital
Division name	Endoscopy
Zip code	8528501
Address	1-7-1, Skamoto, Nagasaki
TEL	095-819-7336
Email	hajimei2002@yahoo.co.jp

Public contact
Name of contact person	1st name Hajime Middle name Last name Isomoto
Organization	Nagasaki University Hospital
Division name	Endoscopy
Zip code	8528501
Address	1-7-1 Nagasaki
TEL	095-819-7336
Homepage URL
Email	hajimei2002@yahoo.co.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Funding Source
Organization	Gastroenterology, Nagasaki University Hospital
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	Nagasaki university hospital
Address	1-7-1 Sakamoto, Nagasaki
Tel	0958197481
Email	kmatsu@nagasaki-u.ac.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	2015 Year 01 Month 01 Day

Related information
URL releasing protocol	http://www.mh.nagasaki-u.ac.jp/research/rinsho/patients/open_gastro.html
Publication of results	Unpublished

Result
URL related to results and publications	http://www.mh.nagasaki-u.ac.jp/research/rinsho/patients/open_gastro.html
Number of participants that the trial has enrolled	0
Results	none
Results date posted	2021 Year 01 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	none
Participant flow	none
Adverse events	none
Outcome measures	none
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 20 Day
Date of IRB	2014 Year 12 Month 17 Day
Anticipated trial start date	2015 Year 01 Month 01 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	patients' background: age, sex, diagnosis disease information: diagnosis, operation, treatment details labratory data: leukocyte counts and fraction, erythrocyte counts, Hb, platelet counts, CRP image findings: endoscopic and magnifying endoscopic findings disease activity index score

Management information
Registered date	2014 Year 12 Month 20 Day
Last modified on	2021 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018620