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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042640
Receipt No. R000048655
Scientific Title Long-Term Outcomes of Bridge to Surgery with Colonic Stents Compared to Transanal Decompression Tubes for Stage II/III Obstructive Left-sided Colorectal Cancer: A Multicenter Randomized Controlled Trial
Date of disclosure of the study information 2021/03/15
Last modified on 2020/12/03

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Basic information
Public title Long-Term Outcomes of Bridge to Surgery with Colonic Stents Compared to Transanal Decompression Tubes for Stage II/III Obstructive Left-sided Colorectal Cancer: A Multicenter Randomized Controlled Trial
Acronym Long-Term Outcomes of Bridge to Surgery with Colonic Stents Compared to Transanal Decompression Tubes for Stage II/III Obstructive Left-sided Colorectal Cancer: A Multicenter Randomized Controlled Trial
Scientific Title Long-Term Outcomes of Bridge to Surgery with Colonic Stents Compared to Transanal Decompression Tubes for Stage II/III Obstructive Left-sided Colorectal Cancer: A Multicenter Randomized Controlled Trial
Scientific Title:Acronym Long-Term Outcomes of Bridge to Surgery with Colonic Stents Compared to Transanal Decompression Tubes for Stage II/III Obstructive Left-sided Colorectal Cancer: A Multicenter Randomized Controlled Trial
Region
Japan

Condition
Condition Colon cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify that BTS with colonic stents is not inferior to TDT in long-term outcomes for cStage II/III left-sided obstructive colorectal cancers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes DFS
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 BTS with TDT
Interventions/Control_2 BTS with SEMS
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. Obstructive left-sided colonic cancer
2. CROSS 0,1
3. cStgae II, III
4. PS 0,1,2
Key exclusion criteria 1. Metachronous cancers
2. Patients with other cancers
3. Tumors located within 10cm from the anal verge.
4. IBD or polyposis syndrome
Target sample size 140

Research contact person
Name of lead principal investigator
1st name Toshio
Middle name Kuwai
Last name Kuwai
Organization Kure Medical Center
Division name Department of Gastroenterology
Zip code 737-0023
Address 3-1 Aoyamacho, Kure, Japan
TEL 0823223111
Email toshiokuwai@gmail.com

Public contact
Name of contact person
1st name Toshio
Middle name
Last name Kuwai
Organization Kure Medical Center
Division name Department of Gastroenterology
Zip code 737-0023
Address 3-1 Aoyamacho, Kure, Japan
TEL 0823223111
Homepage URL
Email toshiokuwai@gmail.com

Sponsor
Institute Kure Medical Center
Institute
Department

Funding Source
Organization AMED
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 Kure Medical Center
Address 3-1 Aoyamacho, Kure, Japan
Tel 0823223111
Email kuwai.toshio.ur@mail.hosp.go.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
2021 Year 03 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
2021 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 12 Month 03 Day
Last modified on
2020 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048655

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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