UMIN-CTR Clinical Trial

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
Email	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
Email	qttsp974@gmail.com

Sponsor
Institute	Department of Gastroenterology, Japanese Red Cross Okayama Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046709