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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024394
Receipt No. R000026529
Scientific Title Randomized controlled study of Pocket-creation method versus conventional method in endoscopic submucosal dissection for superficial colorectal neoplasms.
Date of disclosure of the study information 2016/10/13
Last modified on 2018/10/15

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Basic information
Public title Randomized controlled study of Pocket-creation method versus conventional method in endoscopic submucosal dissection for superficial colorectal neoplasms.
Acronym Randomized study comparing colorectal ESD method.
Scientific Title Randomized controlled study of Pocket-creation method versus conventional method in endoscopic submucosal dissection for superficial colorectal neoplasms.
Scientific Title:Acronym Randomized study comparing colorectal ESD method.
Region
Japan

Condition
Condition Superficial colorectal neoplasms
Classification by specialty
Gastroenterology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of PCM compared with CM in colorectal ESD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of ESD completion
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 ESD using PCM
Interventions/Control_2 ESD using CM
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 Superficial colorectal neoplasms 20mm - 50mm in diameter.
Key exclusion criteria 1)Local recurrence after endoscopic resection.
2)Patients with colitis ulcerosa, Crohn disease, familial adenomatous polyposis.
3)Patients with hematological abnormality.
4)Patients with severe organ failure
5)Patients who have been judged as inappropriate for this study
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironori Yamamoto
Organization Jichi Medical University
Division name Division of Gastroenterology
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
TEL 0285-58-7348
Email yamamoto@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Yamashina
Organization Osaka Red Cross Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 5-30 Fudegasaki, Tenouji, Osaka 543-8555, Japan
TEL 06-(6774)-5111
Homepage URL
Email d1623@jichi.ac.jp

Sponsor
Institute Jichi Medical University
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
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
2016 Year 10 Month 13 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 Completed
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 13 Day
Last modified on
2018 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026529

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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