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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028505
Receipt No. R000032621
Scientific Title Efficacy of preoperative ultrathin colonoscopy for colorectal cancer with stenosis
Date of disclosure of the study information 2017/08/10
Last modified on 2019/08/05

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Basic information
Public title Efficacy of preoperative ultrathin colonoscopy
for colorectal cancer with stenosis
Acronym Ultra C trial
Scientific Title Efficacy of preoperative ultrathin colonoscopy
for colorectal cancer with stenosis
Scientific Title:Acronym Ultra C trial
Region
Japan

Condition
Condition colorectal cancer with stenosis
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of preoperative ultrathin colonoscopy for colorectal cancer with stenosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Passage rate and cecal insertion rate
Key secondary outcomes 1. Neoplastic lesions on the oral side of stenosis
2. Necessity of emergency decompressive treatment
3. Complication rate
4. Neoplastic lesions detected in the initial surveillance colonoscopy after surgery

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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Colorectal cancer cases
2. Cases without standard colonoscopy passage
3. Written informed consent
Key exclusion criteria 1. Intestinal obstruction cases requiring emergency decompressive treatment
2. Unnecessary total colonoscopy
3. Stent insertion cases
4. Inappropriate cases by investigators
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Sayo
Middle name
Last name Ito
Organization Shizuoka Cancer Center
Division name Division of Endoscopy
Zip code 4118777
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL 055-989-5222
Email sa.ito@scchr.jp

Public contact
Name of contact person
1st name Sayo
Middle name
Last name Ito
Organization Shizuoka Cancer Center
Division name Division of Endoscopy
Zip code 4118777
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL 055-989-5222
Homepage URL
Email sa.ito@scchr.jp

Sponsor
Institute Division of Endoscopy, Shizuoka Cancer Center
Institute
Department

Funding Source
Organization Division of Endoscopy, Shizuoka Cancer Center
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 Shizuoka Cancer Cencter
Address 1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
Tel 055-989-5222
Email tansaku_office@scchr.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
2017 Year 08 Month 10 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
2017 Year 07 Month 21 Day
Date of IRB
2017 Year 07 Month 21 Day
Anticipated trial start date
2017 Year 09 Month 04 Day
Last follow-up date
2020 Year 03 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Ultrathin colonoscope: PCF-PQ260L (outer diameter 9.2 mm), Olympus

Management information
Registered date
2017 Year 08 Month 02 Day
Last modified on
2019 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032621

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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