UMIN-CTR Clinical Trial

Basic information
Public title	Safety and Efficacy of a modified small-caliber-tip transparent hood in endoscopic decompression for obstructive colorectal cancer
Acronym	Safety and Efficacy of a modified ST hood in endoscopic decompression for obstructive colorectal cancer
Scientific Title	Safety and Efficacy of a modified small-caliber-tip transparent hood in endoscopic decompression for obstructive colorectal cancer
Scientific Title:Acronym	Safety and Efficacy of a modified ST hood in endoscopic decompression for obstructive colorectal cancer
Region	Japan

Condition
Condition	Obstructive left-sided colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Endoscopic decompression for obstructive colorectal cancer may become easier and more successful by using modified small-caliber-tip transparent hood than by using conventional hood. Comparison on success rate and procedure time in endoscopic decompression for obstructive colorectal cancer between conventional hood and modified ST hood.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Success rate and procedure time to pass the guide-wire through the colorectal stricture site.
Key secondary outcomes	Safety of endoscopic decompression by using modified small-caliber-tip transparent hood.

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	Device,equipment
Interventions/Control_1	Endoscopic decompression using modified ST hood (Replaced with conventional hood only if failure occurs with modified ST hood within a specified time).
Interventions/Control_2	Endoscopic decompression using conventional hood (Replaced with modified ST hood only if failure occurs with conventional hood within a specified time).
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	Patients with colorectal obstruction caused by advanced cancer in the left colon.
Key exclusion criteria	Patients who are under age or patients who informed consent cannot be obtained in person or from the surrogate. Patients who are not candidates for colonoscopy because of concomitant severe infectious disease or underlying severe diseases such as respiratory, circulatory diseases, and etc.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tomohiko Miyata
Organization	Jichi Medical University, Department of Medicine, Division of Gastroenterology and Hepatology
Division name	Endoscopy Center
Zip code
Address	3311-1 Yakushiji Shimotsuke-shi, Tochigi-ken 329-0498
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Jichi Medical University, Department of Medicine, Division of Gastroenterology and Hepatology
Division name	Endoscopy center
Zip code
Address
TEL	0285-58-7539
Homepage URL
Email

Sponsor
Institute	Jichi Medical University, Department of Medicine, Division of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	Jichi Medical University, Department of Endoscopic Research and International Education (Funded by Fujifilm)
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
Address
Tel
Email

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	2009 Year 09 Month 14 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	Open public recruiting
Date of protocol fixation	2009 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date	2009 Year 09 Month 01 Day
Last follow-up date	2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 09 Month 14 Day
Last modified on	2011 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002956

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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