UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038529 |
|---|---|
| Receipt number | 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 | 2023/11/13 21:42:14 |
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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
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
mitsuru10jp@yahoo.co.jp
Sponsor or person
Institute
Shonan Fujisawa Tokushukai Hospital
Institute
Department
Personal name
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
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
No longer 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
| 2023 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043911
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
