UMIN-CTR Clinical Trial

Basic information
Public title	A comparative study of the treatment outcome of transanal decompression tube and colorectal stent for stage II/III obstructive colorectal cancer; retrospective multicenter observational study
Acronym	A comparative study of the treatment outcome of transanal decompression tube and colorectal stent for stage II/III obstructive colorectal cancer; retrospective multicenter observational study
Scientific Title	A comparative study of the treatment outcome of transanal decompression tube and colorectal stent for stage II/III obstructive colorectal cancer; retrospective multicenter observational study
Scientific Title:Acronym	Outcome of transanal decompression tube and colorectal stent for obstructive colorectal cancer
Region	Japan

Condition
Condition	Obstructive Colorectal Cancer
Classification by specialty	Gastrointestinal surgery Operative medicine Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the treatment results of transanal ileus tube and colorectal stent placement for obstructive colorectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relapse Free Survival
Key secondary outcomes	Overall Survival, Postoperative Complication

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	1) 20 to 80 years old 2) Performance status 0-2 3) Histopathologically diagnosed as advanced stage II or III (UICC TNM classification 8th edition) 4) No preoperative chemotherapy or preoperative radiation therapy 5) A transanal decompression tube or colorectal stent was placed before surgery. 6) Radical resection was performed from January 2008 to December 2019.
Key exclusion criteria	1) multiple cancers 2) a history of other cancers within 5 years before surgery (However, carcinoma in situ or intramucosal cancer, which are considered to be cured by local treatment, do not include) 3) Those with lesions in the lower rectum (Rb)
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Koji Middle name Last name Numata
Organization	Kanagawa Cancer Center
Division name	Gastrointestinal Surgery
Zip code	2418515
Address	2-3-2 Nakao, Asahiku, Yokohama, Kanagawa, Japan
TEL	0455202222
Email	koji-numata@hotmail.co.jp

Public contact
Name of contact person	1st name Koji Middle name Last name Numata
Organization	Kanagawa Cancer Center
Division name	Gastrointestinal Surgery
Zip code	2418515
Address	2-3-2 Nakao, Asahiku, Yokohama, Kanagawa, Japan
TEL	0455202222
Homepage URL
Email	koji-numata@hotmail.co.jp

Sponsor
Institute	Kanagawa Cancer Center
Institute
Department

Funding Source
Organization	None
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	Kanagawa Cancer Center
Address	2-3-2 Nakao, Asahiku, Yokohama, Kanagawa, Japan
Tel	0455202222
Email	koji-numata@hotmail.co.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	2022 Year 02 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	No longer recruiting
Date of protocol fixation	2021 Year 12 Month 22 Day
Date of IRB	2022 Year 01 Month 07 Day
Anticipated trial start date	2022 Year 01 Month 07 Day
Last follow-up date	2022 Year 05 Month 10 Day
Date of closure to data entry	2022 Year 11 Month 30 Day
Date trial data considered complete	2022 Year 12 Month 31 Day
Date analysis concluded

Other
Other related information	Retrospective observational study

Management information
Registered date	2022 Year 02 Month 15 Day
Last modified on	2022 Year 12 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052935