UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046922 |
|---|---|
| Receipt number | R000052935 |
| 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 |
| Date of disclosure of the study information | 2022/02/15 |
| Last modified on | 2022/12/01 12:00:29 |
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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
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
koji-numata@hotmail.co.jp
Sponsor or person
Institute
Kanagawa Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052935
