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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038529
Receipt No. R000043911
Scientific Title A randomized controlled trial on the usefulness of underwater endoscopic submucosal dissection (ESD) versus conventional ESD for colorectal tumors
Date of disclosure of the study information 2019/11/10
Last modified on 2019/11/10

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Basic information
Public title A randomized controlled trial on the usefulness of underwater endoscopic submucosal dissection (ESD) versus conventional ESD for colorectal tumors
Acronym A randomized controlled trial on the usefulness of underwater endoscopic submucosal dissection (ESD) versus conventional ESD for colorectal tumors
Scientific Title A randomized controlled trial on the usefulness of underwater endoscopic submucosal dissection (ESD) versus conventional ESD for colorectal tumors
Scientific Title:Acronym A randomized controlled trial on the usefulness of underwater endoscopic submucosal dissection (ESD) versus conventional ESD for colorectal tumors
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the usefulness of underwater ESD for colorectal tumors
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dissection speed
Key secondary outcomes Total volume of injection solution used during the ESD procedure; perforation rate; Frequency of the intraoperative bleeding that requires hemostatic forceps; Post-ESD bleeding rate; Post-ESD coagulation syndrome rate; Variation in white blood cell count, blood CRP level, and blood Na level on the day of and the day after the ESD procedure; Time required to create the mucosal flap; Frequency of UESD interruptions due to bleeding; Time required to return to UESD post-UESD interruption due to bleeding; Frequency of CESD interruptions due to bleeding; Time required to return to CESD post-CESD interruption due to bleeding; Dissection speed according to the lesion location; ESD procedure time according to the lesion location; Dissection speed according to the presence of fibrosis; ESD procedure time according to the presence of fibrosis; Dissection speed according to the positional relationship with gravity; Time for the ESD procedure according to the positional relationship with gravity

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 YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Underwater ESD group
Interventions/Control_2 Conventional 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
94 years-old >
Gender Male and Female
Key inclusion criteria 1) Colorectal tumors that are difficult to resect by EMR
2) No recurrent lesion after an endoscopic treatment
3) No complication such as inflammatory bowel disease
4) Lesion does not extend to the appendix or ileum
5) Written informed consent by the patient
6) Patient age between 20 and 94 years
Key exclusion criteria 1) Pregnant patients or with the possibility of the pregnancy
2) Lactating patients
3) Patients disqualified for this study by the physician
4) Patients who have participated in this study
Target sample size 140

Research contact person
Name of lead principal investigator
1st name Mitsuru
Middle name
Last name Nagata
Organization Shonan Fujisawa Tokushukai Hospital
Division name Department of Endoscopy
Zip code 2510041
Address 1-5-1 TUJIDOUKANDAI FUJISAWA-SHI KANAGAWA JAPAN
TEL 0466351177
Email mitsuru10jp@yahoo.co.jp

Public contact
Name of contact person
1st name Mitsuru
Middle name
Last name Nagata
Organization Shonan Fujisawa Tokushukai Hospital
Division name Department of Endoscopy
Zip code 251-0041
Address 1-5-1 TUJIDOUKANDAI FUJISAWA-SHI KANAGAWA JAPAN
TEL 0466351177
Homepage URL
Email mitsuru10jp@yahoo.co.jp

Sponsor
Institute Shonan Fujisawa Tokushukai Hospital
Institute
Department

Funding Source
Organization Shonan Fujisawa Tokushukai Hospital
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 Mirai Iryo Research Center
Address 1-8-7, Koji-machi, Chiyoda-ku, Tokyo 102-0083, Japan
Tel 03-3263-4801
Email shimizu@mirai-iryo.com

Secondary IDs
Secondary IDs YES
Study ID_1 TGE01276-008
Org. issuing International ID_1 Mirai Iryo Research Center
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 湘南藤沢徳洲会病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 10 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
2019 Year 08 Month 20 Day
Date of IRB
2019 Year 08 Month 20 Day
Anticipated trial start date
2019 Year 11 Month 10 Day
Last follow-up date
2024 Year 12 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
2019 Year 11 Month 10 Day
Last modified on
2019 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043911

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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