UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026317 |
|---|---|
| Receipt number | R000030226 |
| Scientific Title | Evaluation of the efficacy and safety of underwater endoscopic submucosal dissection with pocket creation method for superficial colorectal neoplasms |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2019/03/03 17:33:33 |
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Basic information
Public title
Evaluation of the efficacy and safety of underwater endoscopic submucosal dissection with pocket creation method for superficial colorectal neoplasms
Acronym
Water-pocket ESD for colorectal neoplasms
Scientific Title
Evaluation of the efficacy and safety of underwater endoscopic submucosal dissection with pocket creation method for superficial colorectal neoplasms
Scientific Title:Acronym
Water-pocket ESD for colorectal neoplasms
Region
| Japan |
Condition
Condition
The indicated lesions for ESD in the colorectum
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the efficacy and safety of WP-ESD in the colorectum
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The dissection speed
Key secondary outcomes
The procedure time
The rate of en bloc resection
Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
The group with conventional ESD
Interventions/Control_2
The group with WP-ESD
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
The size of lesion is larger than 2cm and less than 5cm
It is possible to follow the clinical course more than 28 d after ESD
Key exclusion criteria
Patients who have hematological abnormality and/or undergoing hemodialysis
Patients who have serious complications
Patients who are considered to be inappropriate for this study by doctors
Patients who have polypoid lesions and/or inflammatory bowel disease
Women who have baby and are pregnant
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Harada |
Organization
New Tokyo Hospital
Division name
Gastroenterology
Zip code
Address
1271 Wanagaya, Matsudo, Chiba 270-2232 Japan
TEL
047-711-8700
nerimaendo@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Hayasaka |
Organization
New Tokyo Hospital
Division name
Gastroenterology
Zip code
Address
1271 Wanagaya, Matsudo, Chiba 270-2232 Japan
TEL
047-711-8700
Homepage URL
dr25027@gk2.so-net.ne.jp
Sponsor or person
Institute
New Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
New Tokyo 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
Address
Tel
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
| 2017 | Year | 04 | 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | 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
| 2017 | Year | 02 | Month | 27 | Day |
Last modified on
| 2019 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030226
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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