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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044059
Receipt No. R000050218
Scientific Title A prospective randomized trial comparing the pocket-creation method with clip traction and the pocket-creation method of colonic endoscopic submucosal dissection
Date of disclosure of the study information 2021/04/28
Last modified on 2021/05/06

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Basic information
Public title A prospective randomized trial comparing the pocket-creation method with clip traction and the pocket-creation method of colonic endoscopic submucosal dissection
Acronym A prospective randomized trial comparing PCM-CT and PCM of colonic ESD
Scientific Title A prospective randomized trial comparing the pocket-creation method with clip traction and the pocket-creation method of colonic endoscopic submucosal dissection
Scientific Title:Acronym A prospective randomized trial comparing PCM-CT and PCM of colonic ESD
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-CT compared PCM in colonic ESD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dissection speed and procedure time of ESD
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-CT
Interventions/Control_2 ESD using PCM
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Superficial colorectal neoplasms 20 mm - 100 mm in diameter
Key exclusion criteria 1)Patients with lesions extending into the appendix orifice
2)Patients with lesions extending into the diverticulum
3)Patients with lesions extending the ileocecal valve
4)Patients with ulcerative colitis, Crohn disease
5)Patients with sever organ failure
6)Patients with lesion length diameter less than 2 cm, giant lesions with lesion length diameter exceeding 10 cm
7)Patients with rectal (Ra, Rb) lesions
8)Minors (19 years old or younger), seniors 91 years old or older
9)Patients who have been judged as inappropriate for this study
Target sample size 100

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

Public contact
Name of contact person
1st name Takaaki
Middle name
Last name Morikawa
Organization Jichi Medical University
Division name Department of Medicine, Division of Gastroenterology
Zip code 329-0498
Address 3311-1 Yakushiji, Shimotsuke, Tochigi Japan
TEL 0285-58-7348
Homepage URL
Email d2023@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 Jichi Medical University Clinical Research Ethics Committee
Address 3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498
Tel 0285-58-7637
Email rinri@jichi.ac.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
2021 Year 04 Month 28 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
2021 Year 04 Month 27 Day
Date of IRB
2021 Year 04 Month 27 Day
Anticipated trial start date
2021 Year 04 Month 28 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 04 Month 27 Day
Last modified on
2021 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050218

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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