UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040911 |
|---|---|
| Receipt number | R000046709 |
| Scientific Title | Prospective observational study of preoperative complete colorectal evaluation after colorectal stent placement for obstructive colorectal cancer. |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2020/06/26 14:15:11 |
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Basic information
Public title
Prospective observational study of preoperative complete colorectal evaluation after colorectal stent placement for obstructive colorectal cancer.
Acronym
Prospective observational study of preoperative complete colorectal evaluation after colorectal stent placement for obstructive colorectal cancer.
Scientific Title
Prospective observational study of preoperative complete colorectal evaluation after colorectal stent placement for obstructive colorectal cancer.
Scientific Title:Acronym
Prospective observational study of preoperative complete colorectal evaluation after colorectal stent placement for obstructive colorectal cancer.
Region
| Japan |
Condition
Condition
obstructive colorectal cancer
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of preoperative colorectal evaluation after colorectal stent placement for obstructive colorectal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of synchronous colon cancers on the oral side of stenosis
Key secondary outcomes
1.Success rate of complete colonoscopy after colorectal stent placement
2.Complication rate of complete colonoscopy after colorectal stent placement
3.Risk factor of unsuccessful complete colonoscopy after colorectal stent placement
4.Detection rate of neoplastic lesions on the oral side of stenosis using complete colonoscopy
5.Detection rate of neoplastic lesions on the oral side of stenosis using CT colonography
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. Patients who underwent colorectal stent placement for resectable colorectal cancer with stenosis.
2. Provided written informed consent.
Key exclusion criteria
1. Severe complication
2. Within 2 days until surgery after colorectal stent placement
3. Inappropriate cases by investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Akimoto |
Organization
Japanese Red Cross Okayama Hospital
Division name
Department of Gastroenterology
Zip code
700-8607
Address
2-1-1 Aoe, Kita-ku, Okayama City, Okayama, Japan
TEL
086-222-8811
qttsp974@gmail.com
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Akimoto |
Organization
Japanese Red Cross Okayama Hospital
Division name
Department of Gastroenterology
Zip code
700-8607
Address
2-1-1 Aoe, Kita-ku, Okayama City, Okayama, Japan
TEL
086-222-8811
Homepage URL
qttsp974@gmail.com
Sponsor or person
Institute
Department of Gastroenterology, Japanese Red Cross Okayama Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Okayama Hospital
Address
2-1-1 Aoe, Kita-ku, Okayama City, Okayama, Japan
Tel
0862228811
oka-rcgh@okayama-med.jrc.or.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
| 2020 | Year | 07 | Month | 01 | 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
| 2020 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Single center, open-label, prospective cohort study. Between July 1, 2020, and December 31, 2022, consecutive patients with obstructive colorectal cancer who met inclusion criteria.
Management information
Registered date
| 2020 | Year | 06 | Month | 26 | Day |
Last modified on
| 2020 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046709
