UMIN-CTR Clinical Trial

Basic information
Public title	Endoscopic Phenotype of the J pouch in Patients with Ulcerative Colitis: A multi-center retrospective study in Japan
Acronym	Endoscopic Phenotype of the J pouch in Patients with Ulcerative Colitis: A multi-center retrospective study in Japan
Scientific Title	Endoscopic Phenotype of the J pouch in Patients with Ulcerative Colitis: A multi-center retrospective study in Japan
Scientific Title:Acronym	Endoscopic Phenotype of the J pouch in Patients with Ulcerative Colitis: A multi-center retrospective study in Japan
Region	Japan

Condition
Condition	Ulcerative Colitis
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This multi-center retrospective study aims to understand contributing factors to pouch outcomes (chronic pouchitis and pouch failure) by evaluating clinical data and endoscopic pouch phenotypes in patients with ulcerative colitis treated by total proctocolectomy and ileal pouch-anal anastomosis.
Basic objectives2	Others
Basic objectives -Others	To clarify the relevance between endoscopic pouch phenotype and outcomes using multi-center data
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The frequency of chronic pouchitis and pouch failure
Key secondary outcomes	Acute pouchitis, Endoscopic phenotype in patients with acute or chronic pouchitis, Early endoscopic phenotype in patients with chronic pouchitis, co-relationship between clinical symptoms and endoscopic phenotype, and so on

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
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Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Ulcerative colitis patients with medically refractory disease or colitis-associated cancer who required total proctocolectomy with IAA (Ileoanal anastomosis) or IACA (Ileoanal canal anastomosis) between January 2000 and March 2020. Age of the included patients is 18 or more than 18 years old.
Key exclusion criteria	(1) Patients who were preoperatively diagnosed with Crohn's disease or indeterminate colitis (IBD unclassified) (2) Patients who did not perform pouchoscopies after ileostomy takedown
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Kiichiro Middle name Last name Tsuchiya
Organization	University of Tsukuba
Division name	Department of Gastroenterology, Faculty of Medicine
Zip code	305-8575
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-3218
Email	kii.gast@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Shintaro Middle name Last name Akiyama
Organization	University of Tsukuba
Division name	Department of Gastroenterology, Faculty of Medicine
Zip code	305-8575
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-3218
Homepage URL
Email	akiyama@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	University of tsukuba hospital
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel	029-853-3219
Email	tcredo@md.tsukuba.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

国立大学法人　筑波大学　医学医療系　消化器内科　 〒305-8575　茨城県つくば市天王台1-1-1 Tel/Fax：029-853-3218 学校法人　兵庫医科大学　医学部　消化器外科学講座　炎症性腸疾患外科 〒663-8501　兵庫県西宮市武庫川町1-1 Tel/Fax：0798-45-6111 国立大学法人　佐賀大学　医学部　消化器内科 〒849-8501　佐賀県佐賀市鍋島5-1-1 Tel/Fax：0952-31-6511 横浜市立市民病院　炎症性腸疾患科 〒221-0855　神奈川県横浜市神奈川区三ツ沢西町1-1 Tel/Fax：045-316-4580 公立学校法人　奈良県立医科大学　医学部　消化器・総合外科　中央内視鏡部 〒634-8522　奈良県橿原市四条町840 Tel/Fax：0744-22-3051 学校法人　慶應義塾大学　医学部　消化器内科　内視鏡センター 〒160-8582　東京都新宿区信濃町35 Tel/Fax：03-3353-1211 医療法人社団　康喜会　辻中病院柏の葉　消化器内科 〒277-0871　千葉県柏市若柴178番地2柏の葉キャンパス148街区6 Tel/Fax：04-7137-3737 国立大学法人　東京医科歯科大学　医学部　消化器内科　 〒113-8519　東京都文京区湯島1-5-45 Tel/Fax：03-3813-6111 国立大学法人　広島大学　医学部　消化器内科　 〒734-8551　広島県広島市南区霞1-2-3 Tel/Fax：082-257-5555 国立大学法人　旭川医科大学　医学部　内科学講座　病態代謝・消化器・血液腫瘍制御内科学分野（消化器・内視鏡学部門） 〒078-8510 北海道旭川市緑が丘東2条1丁目1-1 Tel/Fax：0166-68-2462 学校法人　関西医科大学　医学部　内科学第三講座　 〒573-1191　大阪府枚方市新町2-3-1 Tel/Fax：072-804-0101 東北大学病院　医科診療部門　総合外科　 〒980-8574　宮城県仙台市青葉区星陵町1-1 Tel/Fax：022-717-7000

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 15 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	Preinitiation
Date of protocol fixation	2022 Year 05 Month 17 Day
Date of IRB
Anticipated trial start date	2022 Year 07 Month 01 Day
Last follow-up date	2028 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We will start collecting data at 12 institutes as a multi-center retrospective study from July 2022.

Management information
Registered date	2022 Year 05 Month 18 Day
Last modified on	2022 Year 05 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054489

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
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