UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047795 |
|---|---|
| Receipt number | R000054489 |
| Scientific Title | Endoscopic Phenotype of the J pouch in Patients with Ulcerative Colitis: A multi-center retrospective study in Japan |
| Date of disclosure of the study information | 2022/06/15 |
| Last modified on | 2022/05/18 18:48:20 |
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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
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
| 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
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
akiyama@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054489
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| Registered date | File name |
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