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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041599
Receipt No. R000046201
Scientific Title Clinical trial of the efficacy of traction method with a band in endoscopic submucosal dissection for colorectal tumor
Date of disclosure of the study information 2020/09/01
Last modified on 2020/09/01

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Basic information
Public title Clinical trial of the efficacy of traction method with a band in endoscopic submucosal dissection for colorectal tumor
Acronym Traction band trial
Scientific Title Clinical trial of the efficacy of traction method with a band in endoscopic submucosal dissection for colorectal tumor
Scientific Title:Acronym Traction band trial
Region
Japan

Condition
Condition Colorectal tumor
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the usefulness of traction using a band in endoscopic submucosal dissection (ESD) for colorectal tumor.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of submucosal resection during colorectal ESD
Key secondary outcomes Procedure time of colorectal ESD,
Adverse event during ESD,
Adverse event after ESD,
Colorectal ESD procedure time and adverse events for each operator,
Procedure time according to macroscopic type,
Pathological assessment (size, adenoma or cancer, depth of cancer, en bloc resection rate, complete en bloc resection rate)
Time required to attach band

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
Maneuver
Interventions/Control_1 Conventional ESD group
Interventions/Control_2 Band-assisted ESD group
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)Early colorectal cancer, size: > 20mm and <= 30mm, depth of cancer invasion: M or SM1.
2)Adequate organ functions defined as;
Hemoglobin of 8.0 g/dl or more
Platelet count 100,000 or more
3)Aged 20 years old or more
4)PS(ECOG), 0 or 1.
5)Written informed consent
Key exclusion criteria 1)Patients with lesions in the Rb.
2)Patients with multiple lesions to be treated.
3)Patients with a bleeding tendency.
4)Patients deviating from the "Gastrointestinal endoscopy practice guidelines for antithrombotic drug recipients (including supplements)" and patients who cannot comply.
5)During dialysis.
6)Inflammatory bowel disease or familial adenomatous polyposis.
7)Lesion on the endoscopic resection scar (EMR or ESD)
8)Past history of colectomy or radiotherapy.
9)Patient considered unsuitable for a clinical trial as determined by the clinician.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Yasuda
Organization St. Marianna University School of Medicine Hospital
Division name Gastroenterology and Hepatology
Zip code 216-8511
Address 2-16-1 Sugao, Gastroenterology and HepatologyMiyamae-ku, Kawasaki-shi, Kanagawa
TEL 0449778111
Email hyasuda@marianna-u.ac.jp

Public contact
Name of contact person
1st name Yasumasa
Middle name
Last name Matsuo
Organization St. Marianna University School of Medicine Hospital, Yokohama City Seibu Hospital
Division name Gastroenterology and Hepatology
Zip code 2410811
Address 1197-1, Yasashi-cho, Asahi-ku, Yokohama-shi, Kanagawa
TEL 0453661111
Homepage URL
Email yasumasa_matsuo@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine Hospital
Institute
Department

Funding Source
Organization St. Marianna University School of Medicine
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 St. Marianna University School of Medicine
Address 2-16-1 Sugao, Gastroenterology and HepatologyMiyamae-ku, Kawasaki-shi, Kanagawa
Tel 0449778111
Email k-sienbu.mail@marianna-u.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
2020 Year 09 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 08 Month 29 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 14 Day
Last follow-up date
2022 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
2020 Year 08 Month 29 Day
Last modified on
2020 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046201

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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